For general information please contact the referral coordinator, Lisa Wallenkamp, at 608-263-7600 or 1-800-386-8684 or email her at referral@vetmed.wisc.edu.
4/10/12: Many new Oncology Clinical Trials Announced
DOGS WITH NEWLY DIAGNOSED OR RECURRENT LYMPHOMA
This clinical trial sponsored by the National Cancer Institute (NCI) assesses the safety and effectiveness of three newly developed chemotherapy agents (Indenoisoquinolines) when given to dogs with lymphoma. Studies in mice and non-tumor-bearing dogs have shown indenoisoquinolines to be safe.
The study involves intravenous administration of an indenoisoquinoline daily for 5 consecutive days. Blood samples, bone marrow biopsies, and tumor biopsies will be collected prior to treatment and following the first and fifth treatment. The first week of this study will necessitate some (minimum of 2 nights) if not all, overnight boarding at the VMTH. Dogs will then return weekly for re-evaluation and subsequent blood collection (Day 8, 15, 22 and 29). Continuance on study beyond day 29 will be based on response to indenoisoquinoline therapy. Costs associated with this study will be provided by the study. In the event any complications arise during the study period, their management will be covered by study funds up to $2000/per dog/per event. This would include any unanticipated hospitalizations. In addition, a gift of $1,000 (one thousand dollars) will be credited to the owner’s VMTH account.
DOGS WITH CUTANEOUS T CELL LYMPHOMA
The most common type of lymphoma in dogs is multicentric, meaning it involves several lymph nodes. A less common type of lymphoma, called cutaneous T cell lymphoma (CTCL), presents as tumors in the skin. While dogs with multicentric lymphoma initially respond to currently available chemotherapy protocols, response rates are considerably lower and generally briefer in duration in patients with CTCL. We previously demonstrated the effectiveness of the novel chemotherapy agent GS-9219 in dogs with multicentric lymphoma in which 100% of newly diagnosed dogs and 60% of previously treated (with chemotherapy drugs other than GS-9219) dogs experienced antitumor responses. One of the observed toxicities in GS-9219-treated dogs was a skin reaction characterized by redness, hair loss, and itching, implying significant delivery of GS-9219 to the skin. Given the lack of effective therapy for canine CTCL and the demonstrated anti-lymphoma activity and apparent skin accumulation of GS-9219, we are evaluating the effectiveness of GS-9219 in canine CTCL. GS-9219 will be administered as a 30-minute intravenous infusion once every 21 days. The owner will be responsible for the costs of the initial examination and tests to insure eligibility to participate (approximately $400). Costs associated with this study will be provided by the study. In addition, a gift of $500 (five hundred dollars) will be credited to the owner’s VMTH account.
DOGS WITH ANY MALIGNANT TUMOR
Doxorubicin is an effective chemotherapy drug commonly used for the treatment of various cancers in dogs including lymphoma, hemangiosarcoma, and osteosarcoma. The lifetime dose of doxorubicin is limited due to its cardiac toxicity, which limits the longterm use of this drug. Doxil®, a doxorubicin containing liposome, has been shown to decrease cardiac toxicity, prolong drug circulation times, and enhance anticancer effects (when compared to free doxorubicin). However, unlike free doxorubicin, a skin reaction (ranging from mild redness and hair loss to severe crusting, ulceration, and peeling of the skin) termed Palmar-Plantar Erythrodysesthesia Syndrome (PPES) or hand-foot syndrome can be dose-limiting for Doxil® in both dogs and people and often prevents repeated dosing. A new formulation of a doxorubicin containing liposome, called PLDMS, has been found to have increased anticancer activity and a reduced incidence of PPES when compared to Doxil®. The purpose of this study is to determine the maximum tolerated dose in dogs and compare the incidence of PPES to dogs in a previous study that had received Doxil®.
This trial is scheduled to open in early May 2012. Dogs with any measurable malignant tumor may be eligible for this study. The study involves intravenous administration of PLDMS once every 3 weeks for a total of 5 treatments. At the time of each treatment, blood and urine tests, and a skin biopsy will be performed. One week after each treatment, a blood test will be performed. The owner will be responsible for the costs of the initial examination and tests to insure eligibility to participate (approximately $400). Costs associated with this study (all treatments and follow-up examinations and procedures) will be provided by the study. In the event any drug-related complications arise during the study period, their management will be covered by study funds up to $3000/per dog. This would include any unanticipated hospitalizations.
DOGS WITH ANY MALIGNANT TUMOR
Computerized tomography (CT) is a commonly used diagnostic tool which provides information regarding the presence of tumors often too small to detect using conventional X-rays. Contrast agents that preferentially bind to tumors are often administered just prior to a CT scan to further enhance the chance of detecting a tumor. One of the limitations of currently used contrast agents is their short half-life, disappearing from the body within hours of administration. A contrast agent that remains in the body longer (for several days without adverse effects) would allow for the performance of multiple CT scans over time which could provide valuable information regarding the effectiveness of anticancer treatments. The purpose of this study is to evaluate a novel imaging agent that has a half-life of at least 24 hours, allowing for the performance of multiple CT scans over time following a single injection, and has been found to provide greater resolution of the CT images which may increase the ability to detect tumors at an earlier stage of development. This is extremely important with regard to the ability to detect metastatic lesions in patients diagnosed with cancer and for the evaluation of the effect of their cancer treatment.
Dogs with any metastatic malignant tumor for which the owner has elected treatment or euthanasia may be eligible for this study. The study involves the performance of 3 CT scans; one prior to administration of the contrast agent, and then again at one and 24 hours after intravenous administration of the contrast agent. The study will cover all costs associated with the performance of the CT scans and, in addition, $1,000 will be credited to the owner’s VMTH account if the dog will be undergoing treatment or $500 will be credited to the owner’s VMTH account if the dog will be euthanized following completion of the CT scans.
DOGS WITH A MALIGNANT MAMMARY TUMOR, MELANOMA, HEAD AND NECK CARCINOMA, OR SOFT TISSUE SARCOMA
The purpose of this study is to assess the safety and effectiveness of iniparib, a novel anticancer agent, in combination with one dose of carboplatin, when given to dogs with cancer. Iniparib has been safely evaluated in human patients with cancer and in normal, non-tumor-bearing dogs. Carboplatin is a commonly used chemotherapy drug for the treatment of cancer in dogs.
Dogs that have been diagnosed with a new or recurrent malignant mammary tumor, melanoma, head and neck carcinoma, or soft tissue sarcoma may be eligible for this study. Dogs will be excluded from this study if they have had any prior therapy for their cancer other than surgery. The study involves four intravenous administrations of iniparib over the course of 22 days and one intravenous administration of chemotherapy (carboplatin) study day 8. Tumor biopsies will be performed prior to starting treatment and then once following each iniparib treatment. Additionally, a physical examination will be performed and a blood sample will be collected prior to starting treatment and then again on study days 1, 4, 8, 11, 15 and 22. After Day 22, dogs will be off study and eligible to pursue other treatments and therapies. Costs associated with this study will be provided by the study. In the event any complications arise during the study period, their management will be covered by study funds up to $2000/per dog/per event. This would include any unanticipated hospitalizations. In addition, a gift of $1,000 (one thousand dollars) will be credited to the owner’s VMTH account.
DOGS WITH MAST CELL TUMORS
Mast cell tumors (MCT) are a common skin tumor of dogs. Current treatment options available for MCT include various combinations of surgery, chemotherapy drugs such as vinblastine or lomustine, radiation therapy, and the new oral MCT drug Palladia® (toceranib). We currently have three clinical trials for dogs with MCT:
• In this third trial, we are investigating a novel anticancer agent which has been shown to have activity in a previous study in pet dogs with naturally occurring tumors. In this study, we will be comparing 4 dosing regimens in dogs with MCT. Dogs with a measurable confirmed MCT that have not received prior chemotherapy (with the exception of prednisone) or radiation therapy may be eligible for this study. Dogs will be randomly assigned to one of 4 dosing regimens and each dog will undergo a total of 4 treatment cycles. The duration of the study is 29 days starting at the time of the first treatment. The owner will be responsible for the costs of the initial examination and tests to insure eligibility to participate (approximately $400). Costs associated with this study (all treatments and follow-up examinations and procedures) will be provided by the study.
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