Study Name: Canine Soft Tissue Sarcoma Vaccine Study
Purpose of the Study: The purpose of this study is to evaluate the effectiveness, and to establish the most appropriate dose of a vaccine intended to inhibit the growth of new blood vessels in tumours. The vaccine is prepared using the DNA from human blood vessel growth factors. Using this specially prepared vaccine, we hope to stimulate a canine patient’s immune system to make antibodies against newly forming blood vessels in a tumour.
Patient Entry Criteria: In general, these studies are available to qualifying patients living within 100 miles of the Animal Cancer Centre at Colorado State University. The patient must have the disease of soft tissue sarcoma, which has been confirmed by biopsy. The soft tissue sarcoma must be measurable and accessible to biopsy. The disease may not have spread to any other area of the body. In order to qualify for this study, treatment prior to presentation to the Animal Cancer Centre must have been very limited. The patient is not to have received radiation therapy, any chemotherapy, or any holistic medical treatment for soft tissue sarcoma prior to entry into the study. The patient must not have received steroids or NSAIDs for four weeks before presentation. No other medical conditions may be present that might limit the patient’s life. No additional medication may be given once the patient is enrolled in the study. For more information regarding entry criteria, please contact the Consult Coordinator at 970-297-4195.
Owner Responsibilities: After the initial diagnostic visit, the client is required to bring the patient
to regularly scheduled visits for treatment and evaluation for up to a year. The client must allow a total of three biopsies to be taken (one pre-treatment and two during treatment) to assess the patient’s response to the vaccine. These biopsy procedures require the patient to be profoundly sedated or anesthetized. No additional medication may be given once the patient is enrolled in the study. Procedures or treatments unrelated to the study will be the owner’s financial responsibility.
Financial Incentives: The owner pays for the initial diagnostic work up, usually $300 to $400. The study pays for all treatment procedures and for all evaluation recheck visits for a period of one year. For more information regarding financial incentives, please contact the Consult Coordinator at
970-297-4195.
Patient Disease: Canine Hemangiosarcoma of the Spleen
Study Name: Hemangiosarcoma Metronomic Chemotherapy Study
Purpose of the Study: The purpose of this study is to evaluate the effectiveness of metronomic chemotherapy for the treatment of canine splenic hemangiosarcoma. Metronomic chemotherapy is a method of delivering chemotherapeutic agents at lower doses, but administering the doses more often. This study is designed as a randomized clinical trial. There are two treatment groups. One group receives doxorubicin (Adriamycin) chemotherapy every two weeks for five treatments. The other group receives metronomic chemotherapy using etoposide, cyclophosphamide, and piroxicam.
Patient Entry Criteria: In general, these studies are available to qualifying patients living within 100 miles of the Animal Cancer Centre at Colorado State University. The patient must have the disease of hemangiosarcoma of the spleen, which has been confirmed by biopsy and histopathology. The spleen must be surgically removed and the disease may not have spread to any other area of the body. In order to qualify for this study, the patient is not to have received radiation therapy, any chemotherapy, or any holistic medical treatment for splenic hemangiosarcoma prior to entry into the study. The patient must not have received steroids, like prednisone, for three weeks prior to presentation. No other medical conditions may be present that might prevent the patient from completing the study. No additional medication related to the disease may be given once the patient is enrolled in the study. For more information regarding entry criteria, please contact the Consult Coordinator at 970-297-4195.
Owner Responsibilities: This study requires frequents visits to the Animal Cancer Centre. The client must schedule and keep all appointments related to the study. Should the owner decide to withdraw from the study, the owner assumes responsibility for all costs incurred.
Financial Incentives: The owner pays for the initial diagnosis and surgical treatment of the disease. Additionally, the owner is responsible for the cost of the staging tests used to determine if the patient meets the eligibility requirements of the study (usually about $600). Once eligible, the study pays for all study-related examinations, tests, and chemotherapy treatments for up to one year. For more information regarding financial incentives, please contact the Consult Coordinator at 970-297-4195.
Patient Disease: Canine Osteosarcoma of a Limb
Study Name: Osteosarcoma and Meloxicam Study
Purpose of the Study: The purpose of this study is to evaluate the benefits of the drug meloxicam in the postoperative pain management of canine patients with osteosarcoma.
Patient Entry Criteria: In general, these studies are available to qualifying patients living within 100 miles of the Animal Cancer Centre at Colorado State University. Eligible patients are dogs with histologically confirmed osteosarcoma of an extremity. The patient’s treatment plan must include amputation of the effected limb followed by doxorubicin (Adriamycin) chemotherapy. Diagnostic evaluation must indicate no spread of cancer in the patient. Additionally, the patient must have no pre-existing heart condition that would make doxorubicin an inappropriate choice for treatment. Patients may not have concurrent disease that might prevent them from completing the study.
Owner Responsibilities: This study pays only the cost of meloxicam. The client is responsible for all costs related to the diagnosis and treatment of the patient’s cancer, and for all costs related to complications that might arise as a result of treatment of the patient’s cancer.
Financial Incentives: This study pays only the cost of meloxicam. For more information regarding financial incentives, please contact the Consult Coordinator at 970-297-4195.
Patient Disease: Canine Patients with Biopsy Confirmed Cancer
Study Name: Silibinin for Canine Tumours
Purpose of the Study: Silibinin is the active ingredient in the herbal compound milk thistle. In
mouse and human tumour cells, silibinin has been shown to inhibit the growth of many types of tumours. In this study we will determine the maximum dose of silibinin that can be safely given to tumour bearing dogs. We will also investigate how effective this compound is in the canine patient.
Patient Entry Criteria: In general, these studies are available to qualifying patients living within 100 miles of the Animal Cancer Centre at Colorado Sate University. The patient will be screened by a variety of diagnostic tests as well as undergo a small biopsy procedure. The owner is financially responsible for tests to meet entry criteria. The patient entry criteria
are as follows:
1. Dogs with a histologically confirmed malignant tumour that is in a location that is easily biopsied.
2. Conventional therapy must have been declined by the owner, or must have failed.
3. Dogs must be free of other life threatening disease.
4. Dogs may not have received chemotherapy within two weeks prior to study entry.
5. Dogs may not have received radiation therapy within six weeks prior to study entry.
6. Other medications are generally acceptable as long as they were begun before entry into the study.
7. Dogs must have relatively normal blood work
Owner Responsibilities: Owners are responsible for delivering the study medication (a powder that can be mixed in a small amount of food) three times daily. Owners are required to make and keep all appointments. Following the initial visit, the patient will be required to return after one week and
then again two weeks later. The owner is financially responsible for the initial tests to see if the patient qualifies for the study, and any costs that follow the 3 week recheck.
Financial Incentives: The study will pay for the blood tests and biopsy at the beginning of the study, and the one week and three week recheck appointments. The drug costs will be covered during the three week study period. After this time, if a patients disease is stable or improved, the drug will continue to be available at no cost; however, a small distribution fee will be assessed by the Pharmacy.
Patient Disease: Canine Mast Cell Tumour Disease
Study Name: Novel Drug Trial for Mast Cell Tumors
Purpose of the Study: The purpose of this study is to demonstrate the effectiveness and safety of a novel drug to control grade II and III mast cell tumours in the canine patient.
Patient Entry Criteria: In general, these studies are available to qualifying patients living within 100 miles of the Animal Cancer Centre at Colorado State University. The patient entry criteria are as follows:
1. Canine patients with one or several mast cell tumours (grade II or III) that have returned after surgery or have been described as non-resectable.
2. Dogs must be older than six months of age and weigh more than 7 pounds.
3. If patients have received chemotherapy, steroids, or had surgery, the study will be delayed by 2 weeks.
4. Dogs that have received radiation therapy must wait 6 weeks before beginning the study.
5. The patient may not have spread of the disease to the lymph nodes or other site.
6. Blood work must be relatively normal.
7. Dogs must be free of other life threatening disease.
Owner Responsibilities: The owner is responsible for the initial examination fee. The owner must schedule and keep all appointments as dictated by the study. The owner must administer the study medication on a daily basis, and must keep a treatment diary, for up to six months.
Financial Incentives: The patient will be screened by a variety of diagnostic tests and may undergo a small biopsy procedure. A portion of the cost of these tests will be paid for by the study. Upon entry into the study, the study pays for subsequent screening visits and diagnostic tests as well as all of the treatment visits.
Patient Disease: Canine patients with a Biopsy Confirmed Malignant Tumour
Study Name: Canine PEG -TNF Study
Purpose of the Study: PEG-TNF is a new formulation of a naturally occurring human hormone. In this study we will determine the maximum dose of PEG -TNF that can be safely given to tumour bearing dogs. We will also investigate how effective this compound is on tumours, that is, their size, the blood flow within tumours and on the tumour cells themselves.
Patient Entry Criteria: In general, these studies are available to qualifying patients living within 100 miles of the Animal Cancer Centre at Colorado State University. The patient will be screened by a variety of diagnostic tests and may undergo a small biopsy procedure. The owner is financially
responsible for tests to meet entry criteria. The patient entry criteria are as follows:
1. Dogs with a histologically confirmed malignant tumour that is in a location that is easily biopsied.
2. Dogs must be free of other life threatening disease.
3. Dogs must have relatively normal blood work.
4. Patients may not have received steroids or NSAIDs (aspirin-like drugs) for 72 hours prior to entry.
5. Dogs may not have received chemotherapy within two weeks prior to study entry.
6. Dogs may not have received radiation therapy within 6 weeks prior to study entry.
7. Candidates must weigh at least 25 pounds.
8. Owners must agree to a postmortem examination (autopsy) at the time of the pet’s death or euthanasia.
Owner Responsibilities: Owners are financially responsible for the diagnostic tests that determine if the patient qualifies for the study. Owners are required to make and keep all appointments. Following the initial visit, the patient will be required to return 4, 7, and 21 days after treatment. Owners must comply with the study protocol. It will be necessary for the patient to submit to having blood samples drawn, the tumour biopsied, and hospitalization. A Magnetic Resonance Image (MRI) may be requested in certain cases. The patient must be anesthetized for a MRI.
Financial Incentives: Once the patient has satisfied the eligibility requirements for the
study, all costs associated with the study will be paid. Additionally, a $250.00 VTH credit will be applied toward any future treatments.
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Jaime F. Modiano, V.M.D., PH. D.
Scientist, Centre for Cancer Causation and Prevention
AMC Cancer Research Centre
Associate Professor, Department of Immunology
University of Colorado Health Sciences Centre
303-239-3408
Dr. Modiano’s lab, is interested in understanding basic differences between normal cells and tumour cells. Their ultimate goal is to reduce the morbidity and mortality associated with cancer in humans and animals.? As they learn more about how cancer cells differ from normal cells, they can exploit these differences to improve diagnosis and treatment and devise better methods of prevention. The purpose of their website, is to provide information for individuals seeking to learn more about cancer, to facilitate recruitment into ongoing studies, and to foster communication among scientists interested in Cancer Biology, Immunology, and Immunotherapy. Vistoris to their website, will find links to publications, study information and recruitment materials, methods and reagents, collaborators, and other useful sites that have cancer information.
Suggestions and feedback are welcome at info@modianolab.org
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Oral Antimitotic Agent for Dogs with Lymphoma
Animal Cancer Institute Studies
Since its inception the Animal Cancer Institute and its Network of veterinary oncologists have offered cutting edge treatment options. The Animal Cancer Institute Network is based in Washington, DC and extends across the United States with sites in California, Connecticut, Florida, Maryland, Massachusetts, New Jersey, New York, Ohio, Texas, Virginia and Washington .
It is the goal of the Animal Cancer Institute to provide more effective and less toxic options for the treatment of cancer. Collaboration with the pharmaceutical industry allows these options to be provided, in many cases, at substantially reduced costs. For more information on the therapeutic diet clinical study for cats with lymphoma, and the Animal Cancer Institute, visit our website at:www.animalcancerinstitute.com.
The Animal Cancer Institute, LLC
Cutting edge options for cancer
C. Khanna DVM, PhD, DACVIM
T. Rusk DVM
For more information, contact
Jennifer Turner:
Phone: 202-363-7300
Fax: 202-363-7126
Email:jturner@animalcancerinstitute.com
You may register your clinic to receive electronic updates on trials available to your clients. Registration for eTrial Updates is available at our website,www.animalcancerinstitute.com.
Oral Antimitotic Agent for Dogs with Lymphoma
Eligibility Criteria Include:
measurable, cytologically diagnosed NH lymphoma (histology collected at study entry)
any clinical stage but must have nodal involvement- includes relapsed cases
favorable performance score
no concurrent chemotherapy (within 14 days of trial entry)
no concurrent radiation therapy (within 21 days of trial entry)
concurrent use of corticosteroids accepted providing treatment duration is greater than 21 days and/or no clinical improvement is noted. Measurable disease defined by examination, radiographs, ultra-sound, CT or MRI scan
Trial Design:
Diagnostic and staging tests may be performed at any veterinary hospital within 10 days of initiation of study:
Serum biochemistry
CBC
Urinalysis
Thoracic and abdominal radiographs
Patients will be treated at a participating Animal Cancer Institute Network clinic. Lymph node biopsies will be required at entry, Day 7, first objective response and at progression or relapse.
Trial Support/Funding Includes:
Laboratory, biopsy and professional fees (as required for the study) from time of enrollment through Day 56 (additional monthly exams beyond Day 56 will be owner?s financial responsibility)
Oral Antimitotic agent through Day 56 (beyond Day 56, additional monthly shipments of study drug supply will be billed to the clinic/investigator at a rate of $50 per shipment)
Dogs will receive the oral medication over a 4-week initial phase. Continued therapy will be available pending response to therapy. Long-term follow-up recheck examinations will be performed monthly.
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Antiangiogenic Therapy for Dogs with Measurable Soft Tissue Sarcomas
Animal Cancer Institute Studies
Since its inception the Animal Cancer Institute and its Network of veterinary oncologists have offered cutting edge treatment options. The Animal Cancer Institute Network is based in Washington, DC and extends across the United States with sites in California, Connecticut, Florida, Maryland, Massachusetts, New Jersey, New York, Ohio, Texas, Virginia and Washington .
The Animal Cancer Institute, LLC
Cutting edge options for cancer
C. Khanna DVM, PhD, DACVIM
T. Rusk DVM
Study Monitor? Kate Cadorette
Phone: 202-363-7300 Fax: 202-363-7126
Email:kcadorette@animalcancerinstitute.com
Trial eligibility criteria include:
client owned pet dogs
measurable, histologically confirmed soft tissue sarcomas, not including hemangiosarcomas
tumors must be accessible for histopath collection and objective measurement using direct caliper measurement, ultrasound, radiographs or CT/MRI scan.
favorable clinical performance status at entry (expected to remain clinically stable for 30 days).
no previous exposure to antiangiogenic therapies
no chemotherapy within 14 days of trial entry
no radiation therapy administered within 21 days of trial entry
corticosteroids and non-steroidal anti-inflammatory agents ok to continue if patient has been receiving for >14 days at time of study entry
Trial Support/Funding Includes:
Antiangiogenic peptide provided at no charge
Biopsy (as required at trial initiation, date of first objective response and date of relapse)
MRI at study entry, and every 3 months through Day 180 for selected patients
All patients must be evaluated and treated through a participating Animal Cancer Institute Network site, monthly.
Diagnostic and staging tests may be performed at any veterinary hospital within 10 days of initiation (full serum chemistry, CBC, U/A and thoracic radiographs).
Dogs will receive a supply of medication for in-home, daily subcutaneous injection or will be treated at a representative clinic every 14 days with a depot injection. Continued therapy will be available pending response to therapy.
All examination, tumor imaging and other diagnostic costs are patient?s responsibility.
Cases which relapse or are refractory following >30 days on antiangiogenic therapy will be eligible to receive open label gemcitabine therapy. Gemcitabine will be provided at no charge – all other costs associated with drug examination and drug administration will be owner responsibility. Assessment of response will be made following the first cycle of therapy and consideration for a
2nd cycle will be made based on patient response.