VARIOUS LOCATIONS
Study: Combined Use of TANOVEA™-CA1 (Rabacfosadine for Injection) and Asparaginase in Dogs with
Relapsed Lymphoma: VC-011
Primary study contact: Kara Hall at csuoncologytrials@colostate.edu or 970-297-4001.
www.csuanimalcancercenter.org/protocol-combined-tanovea-rabacfosadine-injection-and-asparaginase-in-dogs-with-
relapsed-lymphoma
Locations:
Colorado State University--Fort Collins, Colorado
Veterinary Cancer Center--Norwalk, Connecticut
VCA Katonah Bedford Veterinary Center--Bedford Hills, New York
Hope Veterinary Specialists--Malvern, Pennsylvania
VCA Animal Diagnostic Clinic--Dallas, Texas
Specialty and Emergency Pet Hospital--Seattle, Washington
University of Wisconsin--Madison, Wisconsin
Purpose: To evaluate efficacy of rabacfosadine combined with l-asparaginase to treat dogs with relapsed lymphoma
Eligibility: Dogs with confirmed lymphoma that have failed prior treatment are eligible for this study. Dogs must undergo some
diagnostic testing prior to starting the study to ensure that they are eligible, including blood work (complete blood count,
chemistry profile) and urinalysis. Chest X-rays are strongly recommended. Dogs must have good function of liver and
kidneys, have acceptable blood cell counts, and be free of severe underlying disease.
Exclusion: Naive disease, one week washout from chemotherapy, previous pulmonary pathology that may prednisone to
fibrosis. Prior treatment with bleomycin. West Highland White terrier breed.
Summary: Lymphoma is a common cancer in dogs. Current treatment options include various types of chemotherapy;
however, there are no approved drugs for these cancers in dogs, very few dogs are cured and most will relapse. New drugs
remain necessary to treat these drug-resistant relapses. Rabacfosadine is an intravenous chemotherapy agent that has
been used both in normal dogs and in more than 350 dogs with cancer. It has been shown to induce remission in 60 to
100% of dogs with lymphoma. The goal of this study is to evaluate the effectiveness of rabacfosadine, given once every 21
days, when combined with another commonly used chemotherapy drug, asparaginase.
Study Procedures:
Pre-enrollment: Physical exam blood work and urine testing, cytology or histology of tumor, immunophenotyping of the tumor
Rabacfosadine will be administered Day 0 (first day of the clinical trial), Day 21, Day 42, Day 63, and Day 84; at each visit
there will be a physical exam and blood testing and urinalysis performed
L-asparaginase will be administered Day 0 and day 21. Day 7: physical exam and blood test. Once this treatment protocol is
finished, the patient will be rechecked monthly
Owner Responsibilities: To make and keep all appointment according to study protocol, and follow up examinations
Financial incentive: Clients will receive rabacfosadine at no cost. Clients will be responsible for costs of l-asparaginase,
recheck exams, blood tests and any ancillary medications, as well as treatment of any side effects that occur
VARIOUS LOCATIONS
Study: Multi-center prospective study investigating survival in dogs with lymphoma, presumed
intermediate-high grade, treated with prednisone alone
Primary study contact: Chad Johannes at cmj15@iastate.edu or 1-515-294-4900
Locations:
Iowa State University--Ames, Iowa
Veterinary Specialty Hospital--San Diego, California
Sage Centers for Veterinary Specialty and Emergency Care--Campbell, California
Veterinary Specialty Hospital--San Marcos, California
VCA West Los Angeles Animal Hospital--Los Angeles, California
Sage Centers for Veterinary Specialty and Emergency Care--Dublin, California
Pieper Memorial Veterinary Center--Middletown, Connecticut
Blue Pearl Georgia Veterinary Specialists--Atlanta, Georgia
MedVet Medical & Cancer Centers for Pets--Carmel, Indiana
Iowa Veterinary Specialties--Des Moines, Iowa
Oradell Animal Hospital--Paramus, New Jersey
Veterinary Medical Center of Central NY--Syracuse, New York
East End Veterinary Emergency and Specialty Center--Riverhead, New York
MedVet Medical and Cancer Center for Pets--Worthington, Ohio
Summit Veterinary Referral Center--Tacoma, Washington
Background:
Currently, there is no well-defined study regarding the survival and quality of life for dogs with lymphoma treated with
prednisone, an orally administered, inexpensive steroid, despite the drug's inclusion in almost every treatment protocol for
lymphoma. Chemotherapy for canine lymphoma is costly, time-consuming, and has a risk of serious complications.
Prednisone is thought to improve quality of life and reduce lymph node size. But the benefit of this inexpensive, orally
administered drug has not been formally studied.
Purpose of Study:
The Canine LYmPhoma Steriod Only (CALYPSO) is a multi-center study involving 100 dogs with high grade lymphoma from
approximately 15 contributing veterinary schools and specialty practices. We are interested in determining the response to
therapy, how long does it last, if certain types of lymphoma respond better than others to prednisone, and most importantly,
how quality of life is improved.
Eligibility:
Participant dogs need a confirmed diagnosis of intermediate to high-grade lymphoma. Your veterinarian can send aspirates
or tissue samples for analysis to the laboratory of her/his choice or we can do this for you at the hospital. Dogs with
lymphoma in peripheral lymph nodes qualify for the study. Dogs with skin or gastrointestinal lymphoma are not eligible for the
study. Dogs with lymphoma in the spleen and liver only without peripheral lymph node involvement are not eligible. Dogs
receiving any chemotherapy or prednisone before they visit our hospital are not eligible.
Study Procedures:
On the first day, your dog’s quality of life at home will be assessed by having you answer questions about how he/she is
feeling. This questionnaire will be repeated on Day 7, Day 14, and then monthly thereafter. Someone will contact you at
home and review the questions with you if you do not revisit the hospital. Because the response to prednisone may differ
between dogs based on the type of lymphoma (T-cell or B-cell), a fine needle aspiration of a lymph node will be obtained at
the beginning of the study so it can be sent to a lab for special staining. After routine lab tests and a thorough physical exam
including lymph node measurements are completed, your dog will start taking prednisone daily by mouth at home. All dogs
get the same dosage.
Cost:
Medication costs included, other costs go to owner.
INDIANA
Study: Application of Biodynamic Imaging for Personalized Chemotherapy in Canine Lymphoma: A Pilot
Study
Location: Purdue University-West Lafayette, Indiana
Contact information: Sarah Lahrman at salahrma@purdue.edu or 1-765-494-1107
https://vet.purdue.edu/pcop/clinical-trials.php
Objective:
The purpose of this study is to investigate whether an innovative tissue imaging technology, known as biodynamic imaging
(BDI), can be used to predict the responsiveness of canine diffuse large B-cell lymphoma (DLBCL) to chemotherapy. We will
also investigate whether BDI can select, from an array of available chemotherapy drugs, a single drug with best predicted
efficacy against each dog's lymphoma at the time of relapse. Half of the dogs in the study will be randomly assigned to BDI-
selected therapy, and half will be assigned to empiric therapy with lomustine. Dogs will be assessed by a clinician blinded as
to the treatment group during the randomized part of the trial.
Eligibility:
Biopsy- confirmed DLBCL diagnosis of lymphoma
No prior chemotherapy or radiation therapy, including prednisone
Expected survival of at least four weeks
Absence of other serious illness
Adequate bone marrow function in order to receive chemotherapy
Exclusion:
Prior chemotherapy or radiation therapy, including prednisone; Expected survival of less than four weeks; Other serious
illness present; Inadequate bone marrow function in order to receive chemotherapy
Client Compensation:
Cost of biopsies and initial staging tests are paid for by the study. Owners' financial responsibility for chemotherapy
treatments is capped at $50 per visit to Purdue. Pet owners are financially responsible for costs arising from medical
management of treatment-related side effects, as well as other medical conditions not related to lymphoma.
KANSAS
Study: Evaluation of the safety and efficacy of the combination of chemotherapy and ECI-LYM-1 to treat
dogs with newly diagnosed B cell lymphoma
Location: Kansas State University-Manhattan, Kansas
Contact information: Misty Bear at ClinicalTrials@vet.k-state.edu or 1-785-532-3046
www.vet.k-state.edu/vhc/services/clinical-trials
Objective:
The primary purpose of this study is to demonstrate the safety and efficacy of a combination therapeutic protocol,
incorporating chemotherapy and immunotherapy (ECI-LYM-1) which utilizes an autologous tumor vaccine and also infusion of
autologous tumor specific T-cells, in dogs with naturally-occurring B cell lymphoma.
Eligibility:
Histologically/cytologically confirmed canine B-cell lymphoma; ≥18kg dog in sufficiently good health with no underlying
cardiac disease that would preclude the use of doxorubicin. MUST NOT HAVE been previously treated for lymphoma with
steroids (prednisone), radiation, or chemotherapy. Enrolled dogs can be male (either sexually intact or neutered) or female
(either sexually intact or neutered) that is NOT pregnant and NOT lactating.
Exclusion:
Dogs with non-B-cell lymphoma; dogs <18kg; a dog with B-cell lymphoma currently receiving treatments with glucocorticoids
or other cytotoxic agents; the dog has a second malignancy that is not in remission as determined by the clinical investigator;
dog is already undergoing treatment for lymphoma or a secondary malignancy; or the owners have familial, sociological, or
geographical conditions that do not permit adequate medical follow-up and compliance with the study protocol.
Study Procedures:
All dogs will undergo lymph node removal with blood sample collection (for confirmation of diagnosis and vaccine
development) and three doses of doxorubicin chemotherapy for treatment of their lymphoma. Two weeks following the final
doxorubicin treatment, a course of three vaccinations will be administered at weekly intervals. At the time of the last
vaccination, a skin test will be performed to assess the immune response to the vaccine which will require 2 nights of
hospitalization. Apheresis will be performed to extract tumor-specific T lymphocytes from the blood one week after the final
vaccination. Your dog will remain hospitalized for two nights following this procedure and receive an additional skin test to
assess their immune response to the vaccine. Low-dose, oral chemotherapy (cyclophosphamide) will be administered over 2-
4 days at home in the week following apheresis. The T cells extracted during apheresis will be expanded at ELIAS Animal
Health and will be re-infused 1 week after apheresis. Low-dose IL-2 will be administered starting 24 hours after the T cell
infusion and will continue for 5 total injections under the skin on an every other day basis. A post treatment follow up visit will
occur on day 93.
Client Compensation:
Once informed consent is obtained and preliminary diagnosis and staging is performed, this trial provides full funding for all
treatment-related costs including surgery and all subsequent re-evaluations while on trial, all necessary diagnostics
(bloodwork, radiographs), treatment, vaccine administration, apheresis, T cell infusion, and management of adverse events
that are possibly attributed to therapy. The owner is responsible for the costs associated with the initial oncology
consultation, lymph node aspirate, and diagnostic cytometry to confirm diagnosis.
OHIO
Study: An Exploratory Study of the Safety and Efficacy of a Novel Small Molecule Inhibitor in Dogs with
Lymphoma
Location: Ohio State University-Columbus, Ohio
Contact information: Blue Buffalo Clinical Trials Office at CVM-ClinicalTrials@osu.edu or 1-614-2478706
http://vet.osu.edu/vmc/cto/clinical-trials/dogs-lymphoma
Purpose:
The primary objective of this study is to evaluate the activity of an investigational drug given to dogs with lymphoma that have
not yet been treated or have failed chemotherapy. This investigational drug inhibits a very important pathway that has been
shown to induce cell death in lymphoma cells holding great promise for treating lymphoma and possibly other cancers.
Eligibility:
To participate in this clinical trial your dog must have:
- A diagnosis of lymphoma
- Prior chemotherapy or radiation must be completed 2 weeks prior to study entry
- Dogs must have gross/measurable disease (approximately 2 cm)
- Dogs must be free of other diseases (heart, liver, and kidney) and be feeling good (playing, good appetite).
- Your dog will be screened for eligibility based on bloodwork (complete blood count, biochemistry profile, urinalysis, chest x-
rays, abdominal ultrasound)
Exclusion:
- Pregnant or lactating dogs
- Evidence of brain metastasis
- Dogs with uncontrolled autoimmune hemolytic anemia (AIHA) or immune mediated thrombocytopenia (ITP) are not eligible.
- Concurrent use of complementary or alternative medicines that in the opinion of the principal investigators would confound
the interpretation of toxicities and/or antitumor activity of the study drug
- Dogs with significant cardiovascular disease
- Less than 2 weeks from a major surgical procedure
- Any serious systemic disorder incompatible with the study (at the discretion of the principal investigators)
- Use of any other investigational drug within 1 week of study entry.
Study Procedures:
Your dog will receive the investigational drug intravenously (IV) weekly (every 7 days) or bi-weekly (every 14 days). Your
dog will return weekly for the first 4 weeks, then every other week thereafter as long as your dog has experienced a complete
response, partial response, or stable disease following treatment. Analysis for tumor response will be performed by direct
tumor measurement or through the use of imaging (radiographs, ultrasound, CT). Standard bloodwork will be performed at
each visit. Additional tests to be performed include blood draws, a collection of peripheral blood cells (PBCs), fine needle
aspirates (FNAs) and biopsies of the lymph nodes to determine how the investigational drug is affecting the cancer cells. For
the first and fourth treatments of the study, your dog will stay in the hospital overnight one or two nights so that blood
samples can be drawn over 24 hours to assess how the investigational drug blood levels change during the course of the
day. The total volume of blood involved in this collection is approximately 6 tablespoons.
Financial Incentive:
Following your dog’s completion of the clinical trial, you will receive a credit of $1000 for continued treatment of your dog at
the Veterinary Medical Center. The clinical trial will cover the costs associated with trial screening for dogs that are eligible
for the trial and enroll in the study. Screening costs will not be paid for ineligible dogs. For eligible, enrolled dogs, the clinical
trial will cover all costs associated with screening prior to study entry, all treatments, and treatment of any side effects
associated with the treatment.
NORTH CAROLINA
Study #1: Immunolight Therapy for Canine Cancer
Location: North Carolina State University-Raleigh, North Carolina
Contact information: Carrie Muller at 919-515-8380 or 919-513-6453 or ccmtr_csc@ncsu.edu
https://cvm.ncsu.edu/research/clinical-trials/list/
For a study flyer, please click here.
Objective:
After a successful phase I safety study, the goal of this new research project is to continue studying and refining Immunolight
Therapy, an innovative approach to cancer treatment. We will to evaluate the clinical and immunologic activity of Immunolight
Therapy (IT) in dogs with spontaneously-occurring solid tumors and lymphoma. This study is financially supported by
Immunolight, LLC., and NC State CVM. More information about Immunolight Therapy, and study eligibility, can be found at
www.immunolight.com
Eligibility:
Lymphoma (newly diagnosed, or if chemotherapy is no longer working), Oral Melanoma, Other tumor types (e.g., dogs with
tumors of the skin, toes, mouth, perineum and other sites MAY be eligible). Must be greater than 1 year old and have
histologic or cytologic evidence of neoplasia prior to treatment. Patients must have previous diagnosis to be eligible for
study. Testing requirements vary.
Please contact site for additional specific Inclusion/Exclusion criteria.
Exclusion:
Most internal tumors will NOT be eligible. Patients may not receive other treatments for their tumor prior to, or during
enrollment in study.
Client Compensation:
Patients will receive a variety of initial staging tests, free Immunolight Therapy sessions, free follow-up visits and
compensation up to $500 may be available.
Study #2: Quantitative Assessment of minimal residual disease kinetics during CHOP chemotherapy of
canine T-Cell lymphoma via next-generation TCRVB sequencing
Location: North Carolina State University-Raleigh, North Carolina
Contact information: Dr. Paul R. Hess at paul_hess@ncsu.edu
https://cvm.ncsu.edu/research/clinical-trials/list/
Summary:
While most dogs that receive chemotherapy for T-cell lymphoma temporarily attain remission and regain health, long-term
survivals are precluded by the inevitable expansion of tiny numbers of drug-resistant cancer cells that persist throughout
treatment. Measuring changing levels of these cancerous T cells could permit a lymphoma’s particular sensitivity pattern to
individual agents in a multidrug protocol to be deduced, so that only highly effective drugs are used; however, conventional
means of detection are unfortunately too insensitive for this purpose, exactly when cancer burdens are minimal and
consequently most susceptible to chemotherapy. Because each T cell bears a unique genetic fingerprint, we have shown
that next-generation DNA sequencing can be used to quantify rare lymphoma cells, even when concealed in large mixtures of
normal T cells. In the current clinical trial, such sequencing will be used to periodically measure changes in circulating
cancerous T cells in dogs with lymphoma as a means to estimate the acquisition of resistance to different drugs given on a
rotating basis in a commonly used treatment protocol. Ultimately, this revolutionary technology, when employed in “real-time”,
will allow veterinary oncologists to prescribe customized chemotherapy regimens that are continuously tailored to the
changing drug sensitivity of a patient’s cancer, preventing administration of ineffective treatments and increasing the chance
for cure.
Eligibility:
Participants for this study will be recruited from dogs with suspected high-grade, multicentric lymphoma that present to the
NC State Veterinary Hospital Medical Oncology Service for diagnostic evaluation and chemotherapy treatment. Eligible dogs
will be identified by analysis of cancerous cells taken from an enlarged lymph node by fine needle aspiration.
Client Compensation:
Flow cytometric immunophenotyping of lymph node fine needle aspirates.
Study: Combined Use of TANOVEA™-CA1 (Rabacfosadine for Injection) and Asparaginase in Dogs with
Relapsed Lymphoma: VC-011
Primary study contact: Kara Hall at csuoncologytrials@colostate.edu or 970-297-4001.
www.csuanimalcancercenter.org/protocol-combined-tanovea-rabacfosadine-injection-and-asparaginase-in-dogs-with-
relapsed-lymphoma
Locations:
Colorado State University--Fort Collins, Colorado
Veterinary Cancer Center--Norwalk, Connecticut
VCA Katonah Bedford Veterinary Center--Bedford Hills, New York
Hope Veterinary Specialists--Malvern, Pennsylvania
VCA Animal Diagnostic Clinic--Dallas, Texas
Specialty and Emergency Pet Hospital--Seattle, Washington
University of Wisconsin--Madison, Wisconsin
Purpose: To evaluate efficacy of rabacfosadine combined with l-asparaginase to treat dogs with relapsed lymphoma
Eligibility: Dogs with confirmed lymphoma that have failed prior treatment are eligible for this study. Dogs must undergo some
diagnostic testing prior to starting the study to ensure that they are eligible, including blood work (complete blood count,
chemistry profile) and urinalysis. Chest X-rays are strongly recommended. Dogs must have good function of liver and
kidneys, have acceptable blood cell counts, and be free of severe underlying disease.
Exclusion: Naive disease, one week washout from chemotherapy, previous pulmonary pathology that may prednisone to
fibrosis. Prior treatment with bleomycin. West Highland White terrier breed.
Summary: Lymphoma is a common cancer in dogs. Current treatment options include various types of chemotherapy;
however, there are no approved drugs for these cancers in dogs, very few dogs are cured and most will relapse. New drugs
remain necessary to treat these drug-resistant relapses. Rabacfosadine is an intravenous chemotherapy agent that has
been used both in normal dogs and in more than 350 dogs with cancer. It has been shown to induce remission in 60 to
100% of dogs with lymphoma. The goal of this study is to evaluate the effectiveness of rabacfosadine, given once every 21
days, when combined with another commonly used chemotherapy drug, asparaginase.
Study Procedures:
Pre-enrollment: Physical exam blood work and urine testing, cytology or histology of tumor, immunophenotyping of the tumor
Rabacfosadine will be administered Day 0 (first day of the clinical trial), Day 21, Day 42, Day 63, and Day 84; at each visit
there will be a physical exam and blood testing and urinalysis performed
L-asparaginase will be administered Day 0 and day 21. Day 7: physical exam and blood test. Once this treatment protocol is
finished, the patient will be rechecked monthly
Owner Responsibilities: To make and keep all appointment according to study protocol, and follow up examinations
Financial incentive: Clients will receive rabacfosadine at no cost. Clients will be responsible for costs of l-asparaginase,
recheck exams, blood tests and any ancillary medications, as well as treatment of any side effects that occur
VARIOUS LOCATIONS
Study: Multi-center prospective study investigating survival in dogs with lymphoma, presumed
intermediate-high grade, treated with prednisone alone
Primary study contact: Chad Johannes at cmj15@iastate.edu or 1-515-294-4900
Locations:
Iowa State University--Ames, Iowa
Veterinary Specialty Hospital--San Diego, California
Sage Centers for Veterinary Specialty and Emergency Care--Campbell, California
Veterinary Specialty Hospital--San Marcos, California
VCA West Los Angeles Animal Hospital--Los Angeles, California
Sage Centers for Veterinary Specialty and Emergency Care--Dublin, California
Pieper Memorial Veterinary Center--Middletown, Connecticut
Blue Pearl Georgia Veterinary Specialists--Atlanta, Georgia
MedVet Medical & Cancer Centers for Pets--Carmel, Indiana
Iowa Veterinary Specialties--Des Moines, Iowa
Oradell Animal Hospital--Paramus, New Jersey
Veterinary Medical Center of Central NY--Syracuse, New York
East End Veterinary Emergency and Specialty Center--Riverhead, New York
MedVet Medical and Cancer Center for Pets--Worthington, Ohio
Summit Veterinary Referral Center--Tacoma, Washington
Background:
Currently, there is no well-defined study regarding the survival and quality of life for dogs with lymphoma treated with
prednisone, an orally administered, inexpensive steroid, despite the drug's inclusion in almost every treatment protocol for
lymphoma. Chemotherapy for canine lymphoma is costly, time-consuming, and has a risk of serious complications.
Prednisone is thought to improve quality of life and reduce lymph node size. But the benefit of this inexpensive, orally
administered drug has not been formally studied.
Purpose of Study:
The Canine LYmPhoma Steriod Only (CALYPSO) is a multi-center study involving 100 dogs with high grade lymphoma from
approximately 15 contributing veterinary schools and specialty practices. We are interested in determining the response to
therapy, how long does it last, if certain types of lymphoma respond better than others to prednisone, and most importantly,
how quality of life is improved.
Eligibility:
Participant dogs need a confirmed diagnosis of intermediate to high-grade lymphoma. Your veterinarian can send aspirates
or tissue samples for analysis to the laboratory of her/his choice or we can do this for you at the hospital. Dogs with
lymphoma in peripheral lymph nodes qualify for the study. Dogs with skin or gastrointestinal lymphoma are not eligible for the
study. Dogs with lymphoma in the spleen and liver only without peripheral lymph node involvement are not eligible. Dogs
receiving any chemotherapy or prednisone before they visit our hospital are not eligible.
Study Procedures:
On the first day, your dog’s quality of life at home will be assessed by having you answer questions about how he/she is
feeling. This questionnaire will be repeated on Day 7, Day 14, and then monthly thereafter. Someone will contact you at
home and review the questions with you if you do not revisit the hospital. Because the response to prednisone may differ
between dogs based on the type of lymphoma (T-cell or B-cell), a fine needle aspiration of a lymph node will be obtained at
the beginning of the study so it can be sent to a lab for special staining. After routine lab tests and a thorough physical exam
including lymph node measurements are completed, your dog will start taking prednisone daily by mouth at home. All dogs
get the same dosage.
Cost:
Medication costs included, other costs go to owner.
INDIANA
Study: Application of Biodynamic Imaging for Personalized Chemotherapy in Canine Lymphoma: A Pilot
Study
Location: Purdue University-West Lafayette, Indiana
Contact information: Sarah Lahrman at salahrma@purdue.edu or 1-765-494-1107
https://vet.purdue.edu/pcop/clinical-trials.php
Objective:
The purpose of this study is to investigate whether an innovative tissue imaging technology, known as biodynamic imaging
(BDI), can be used to predict the responsiveness of canine diffuse large B-cell lymphoma (DLBCL) to chemotherapy. We will
also investigate whether BDI can select, from an array of available chemotherapy drugs, a single drug with best predicted
efficacy against each dog's lymphoma at the time of relapse. Half of the dogs in the study will be randomly assigned to BDI-
selected therapy, and half will be assigned to empiric therapy with lomustine. Dogs will be assessed by a clinician blinded as
to the treatment group during the randomized part of the trial.
Eligibility:
Biopsy- confirmed DLBCL diagnosis of lymphoma
No prior chemotherapy or radiation therapy, including prednisone
Expected survival of at least four weeks
Absence of other serious illness
Adequate bone marrow function in order to receive chemotherapy
Exclusion:
Prior chemotherapy or radiation therapy, including prednisone; Expected survival of less than four weeks; Other serious
illness present; Inadequate bone marrow function in order to receive chemotherapy
Client Compensation:
Cost of biopsies and initial staging tests are paid for by the study. Owners' financial responsibility for chemotherapy
treatments is capped at $50 per visit to Purdue. Pet owners are financially responsible for costs arising from medical
management of treatment-related side effects, as well as other medical conditions not related to lymphoma.
KANSAS
Study: Evaluation of the safety and efficacy of the combination of chemotherapy and ECI-LYM-1 to treat
dogs with newly diagnosed B cell lymphoma
Location: Kansas State University-Manhattan, Kansas
Contact information: Misty Bear at ClinicalTrials@vet.k-state.edu or 1-785-532-3046
www.vet.k-state.edu/vhc/services/clinical-trials
Objective:
The primary purpose of this study is to demonstrate the safety and efficacy of a combination therapeutic protocol,
incorporating chemotherapy and immunotherapy (ECI-LYM-1) which utilizes an autologous tumor vaccine and also infusion of
autologous tumor specific T-cells, in dogs with naturally-occurring B cell lymphoma.
Eligibility:
Histologically/cytologically confirmed canine B-cell lymphoma; ≥18kg dog in sufficiently good health with no underlying
cardiac disease that would preclude the use of doxorubicin. MUST NOT HAVE been previously treated for lymphoma with
steroids (prednisone), radiation, or chemotherapy. Enrolled dogs can be male (either sexually intact or neutered) or female
(either sexually intact or neutered) that is NOT pregnant and NOT lactating.
Exclusion:
Dogs with non-B-cell lymphoma; dogs <18kg; a dog with B-cell lymphoma currently receiving treatments with glucocorticoids
or other cytotoxic agents; the dog has a second malignancy that is not in remission as determined by the clinical investigator;
dog is already undergoing treatment for lymphoma or a secondary malignancy; or the owners have familial, sociological, or
geographical conditions that do not permit adequate medical follow-up and compliance with the study protocol.
Study Procedures:
All dogs will undergo lymph node removal with blood sample collection (for confirmation of diagnosis and vaccine
development) and three doses of doxorubicin chemotherapy for treatment of their lymphoma. Two weeks following the final
doxorubicin treatment, a course of three vaccinations will be administered at weekly intervals. At the time of the last
vaccination, a skin test will be performed to assess the immune response to the vaccine which will require 2 nights of
hospitalization. Apheresis will be performed to extract tumor-specific T lymphocytes from the blood one week after the final
vaccination. Your dog will remain hospitalized for two nights following this procedure and receive an additional skin test to
assess their immune response to the vaccine. Low-dose, oral chemotherapy (cyclophosphamide) will be administered over 2-
4 days at home in the week following apheresis. The T cells extracted during apheresis will be expanded at ELIAS Animal
Health and will be re-infused 1 week after apheresis. Low-dose IL-2 will be administered starting 24 hours after the T cell
infusion and will continue for 5 total injections under the skin on an every other day basis. A post treatment follow up visit will
occur on day 93.
Client Compensation:
Once informed consent is obtained and preliminary diagnosis and staging is performed, this trial provides full funding for all
treatment-related costs including surgery and all subsequent re-evaluations while on trial, all necessary diagnostics
(bloodwork, radiographs), treatment, vaccine administration, apheresis, T cell infusion, and management of adverse events
that are possibly attributed to therapy. The owner is responsible for the costs associated with the initial oncology
consultation, lymph node aspirate, and diagnostic cytometry to confirm diagnosis.
OHIO
Study: An Exploratory Study of the Safety and Efficacy of a Novel Small Molecule Inhibitor in Dogs with
Lymphoma
Location: Ohio State University-Columbus, Ohio
Contact information: Blue Buffalo Clinical Trials Office at CVM-ClinicalTrials@osu.edu or 1-614-2478706
http://vet.osu.edu/vmc/cto/clinical-trials/dogs-lymphoma
Purpose:
The primary objective of this study is to evaluate the activity of an investigational drug given to dogs with lymphoma that have
not yet been treated or have failed chemotherapy. This investigational drug inhibits a very important pathway that has been
shown to induce cell death in lymphoma cells holding great promise for treating lymphoma and possibly other cancers.
Eligibility:
To participate in this clinical trial your dog must have:
- A diagnosis of lymphoma
- Prior chemotherapy or radiation must be completed 2 weeks prior to study entry
- Dogs must have gross/measurable disease (approximately 2 cm)
- Dogs must be free of other diseases (heart, liver, and kidney) and be feeling good (playing, good appetite).
- Your dog will be screened for eligibility based on bloodwork (complete blood count, biochemistry profile, urinalysis, chest x-
rays, abdominal ultrasound)
Exclusion:
- Pregnant or lactating dogs
- Evidence of brain metastasis
- Dogs with uncontrolled autoimmune hemolytic anemia (AIHA) or immune mediated thrombocytopenia (ITP) are not eligible.
- Concurrent use of complementary or alternative medicines that in the opinion of the principal investigators would confound
the interpretation of toxicities and/or antitumor activity of the study drug
- Dogs with significant cardiovascular disease
- Less than 2 weeks from a major surgical procedure
- Any serious systemic disorder incompatible with the study (at the discretion of the principal investigators)
- Use of any other investigational drug within 1 week of study entry.
Study Procedures:
Your dog will receive the investigational drug intravenously (IV) weekly (every 7 days) or bi-weekly (every 14 days). Your
dog will return weekly for the first 4 weeks, then every other week thereafter as long as your dog has experienced a complete
response, partial response, or stable disease following treatment. Analysis for tumor response will be performed by direct
tumor measurement or through the use of imaging (radiographs, ultrasound, CT). Standard bloodwork will be performed at
each visit. Additional tests to be performed include blood draws, a collection of peripheral blood cells (PBCs), fine needle
aspirates (FNAs) and biopsies of the lymph nodes to determine how the investigational drug is affecting the cancer cells. For
the first and fourth treatments of the study, your dog will stay in the hospital overnight one or two nights so that blood
samples can be drawn over 24 hours to assess how the investigational drug blood levels change during the course of the
day. The total volume of blood involved in this collection is approximately 6 tablespoons.
Financial Incentive:
Following your dog’s completion of the clinical trial, you will receive a credit of $1000 for continued treatment of your dog at
the Veterinary Medical Center. The clinical trial will cover the costs associated with trial screening for dogs that are eligible
for the trial and enroll in the study. Screening costs will not be paid for ineligible dogs. For eligible, enrolled dogs, the clinical
trial will cover all costs associated with screening prior to study entry, all treatments, and treatment of any side effects
associated with the treatment.
NORTH CAROLINA
Study #1: Immunolight Therapy for Canine Cancer
Location: North Carolina State University-Raleigh, North Carolina
Contact information: Carrie Muller at 919-515-8380 or 919-513-6453 or ccmtr_csc@ncsu.edu
https://cvm.ncsu.edu/research/clinical-trials/list/
For a study flyer, please click here.
Objective:
After a successful phase I safety study, the goal of this new research project is to continue studying and refining Immunolight
Therapy, an innovative approach to cancer treatment. We will to evaluate the clinical and immunologic activity of Immunolight
Therapy (IT) in dogs with spontaneously-occurring solid tumors and lymphoma. This study is financially supported by
Immunolight, LLC., and NC State CVM. More information about Immunolight Therapy, and study eligibility, can be found at
www.immunolight.com
Eligibility:
Lymphoma (newly diagnosed, or if chemotherapy is no longer working), Oral Melanoma, Other tumor types (e.g., dogs with
tumors of the skin, toes, mouth, perineum and other sites MAY be eligible). Must be greater than 1 year old and have
histologic or cytologic evidence of neoplasia prior to treatment. Patients must have previous diagnosis to be eligible for
study. Testing requirements vary.
Please contact site for additional specific Inclusion/Exclusion criteria.
Exclusion:
Most internal tumors will NOT be eligible. Patients may not receive other treatments for their tumor prior to, or during
enrollment in study.
Client Compensation:
Patients will receive a variety of initial staging tests, free Immunolight Therapy sessions, free follow-up visits and
compensation up to $500 may be available.
Study #2: Quantitative Assessment of minimal residual disease kinetics during CHOP chemotherapy of
canine T-Cell lymphoma via next-generation TCRVB sequencing
Location: North Carolina State University-Raleigh, North Carolina
Contact information: Dr. Paul R. Hess at paul_hess@ncsu.edu
https://cvm.ncsu.edu/research/clinical-trials/list/
Summary:
While most dogs that receive chemotherapy for T-cell lymphoma temporarily attain remission and regain health, long-term
survivals are precluded by the inevitable expansion of tiny numbers of drug-resistant cancer cells that persist throughout
treatment. Measuring changing levels of these cancerous T cells could permit a lymphoma’s particular sensitivity pattern to
individual agents in a multidrug protocol to be deduced, so that only highly effective drugs are used; however, conventional
means of detection are unfortunately too insensitive for this purpose, exactly when cancer burdens are minimal and
consequently most susceptible to chemotherapy. Because each T cell bears a unique genetic fingerprint, we have shown
that next-generation DNA sequencing can be used to quantify rare lymphoma cells, even when concealed in large mixtures of
normal T cells. In the current clinical trial, such sequencing will be used to periodically measure changes in circulating
cancerous T cells in dogs with lymphoma as a means to estimate the acquisition of resistance to different drugs given on a
rotating basis in a commonly used treatment protocol. Ultimately, this revolutionary technology, when employed in “real-time”,
will allow veterinary oncologists to prescribe customized chemotherapy regimens that are continuously tailored to the
changing drug sensitivity of a patient’s cancer, preventing administration of ineffective treatments and increasing the chance
for cure.
Eligibility:
Participants for this study will be recruited from dogs with suspected high-grade, multicentric lymphoma that present to the
NC State Veterinary Hospital Medical Oncology Service for diagnostic evaluation and chemotherapy treatment. Eligible dogs
will be identified by analysis of cancerous cells taken from an enlarged lymph node by fine needle aspiration.
Client Compensation:
Flow cytometric immunophenotyping of lymph node fine needle aspirates.
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Last updated 2/19/2017
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