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Radioactive Gold Nanoparticle Brachytherapy for imaging and treatment of canine prostate cancer - The purpose of this study is to demonstrate preliminary tolerability and efficacy of radioactive gold nanoparticle (GA198AuNP) brachytherapy when administered intratumorally.
Criteria:
- Dogs with a cytologic or histologic diagnosis of prostatic carcinoma.
- Life expectancy of > 6 weeks; must be good candidate for 5-7 days in radiation isolation.
- NSAIDS or steroids allowed if patient has been on them for > 2 weeks prior to injection.
- Prior chemotherapy allowed if performed > 3 weeks prior to injection.
- CBC, Chemistry panel, Urinalysis, Thoracic rads and Abdominal Ultrasound required.
- Exclusion: Metastasis to distant locations
- No weight restriction
Therapy:
- Dogs will receive GA- 198AuNPs injected with CT guidance into the tumor. CT scans will be done prior to injection to allow for dosimetry.
- All dogs will be hospitalized in radiation isolation for 5-7 days
- Weekly CBC, chemistry panel and urinalysis for 4 weeks post release from radiation isolation.
- CT scan 4 weeks following treatment.
Benefit:
- Treatment is provided at no cost to the owner. This includes initial staging; CT scans prior to and after treatment, gold nanoparticle, board in radiation isolation and follow-up blood work and imaging done at the VMTH. Owners may pursue alternate treatment following the CT scan at 4 weeks and treatment following completion of the study. This will be the financial responsibility of the owner.
Contact Faculty Person: Dr. Sandra Axiak
CTI-52010 is a new nanoparticle taxane drug that has been developed to avoid the allergic reactions of earlier taxanes. It has already been shown to be safe in normal dogs. This clinical trial will refine the proper dosage for dogs with cancer and determine whether there is evidence of efficacy.
Criteria:
- Any tumor (except osteosarcoma, lymphoma , prostate carcinoma) confirmed by histopathology or cytology
- Normal CBC, renal and liver function, UA and thoracic radiographs at first visit.
- 28 day washout from last chemotherapy
- Patient must weigh over 10 kgs
Therapy:
- CTI-52010 every 3 weeks for a total of 4 treatments
- CBC, chemistry panel, UA on days 0, 7, 21, 28, 42, 49, 63, 70 and 84. Thoracic radiographs on day 0 and 63, then every 2 months thereafter.
Benefit:
- Once enrolled study is fully funded. Treatment includes: free drug and drug administration, hospitalization for 1st night, blood work, imaging (rads & U/S) and office calls.
- Initial workup is owner’s responsibility.
Contact Faculty Person: Dr. Kim Selting
Tavocept use to mitigate nephrotoxicity associated with cisplatin and piroxicam treatment of canine bladder cancer
The purpose of this study is to evaluate the efficacy of Tavocept in preventing drug-induced toxicity (especially nephrotoxicity) associated with cisplatin and piroxicam therapy for canine bladder cancer and to demonstrate that administration of Tavocept prior to cisplatin chemotherapy in tumor-bearing dogs facilitates the safe use of a shortened diuresis protocol as is the case in people. The overall study goal is to develop a safer (non-nephrotoxic) and more efficacious treatment regimen for dogs with TCC of the urinary bladder by the use of the novel cytoprotective and antitumor potentiating agent, Tavocept.
Criteria:
- Measureable confirmed TCC of the urinary bladder
- No previous chemotherapy, radiation therapy or excisional surgery for TCC
- NSAID’s must be discontinued for at least 14 days prior to study enrollment
- Adequate renal function-normal creatinine and BUN on VMTH panel and adequate urine specific gravity.
- No serious or life –threatening concurrent disease reducing life expectancy to < 16 weeks
- PCV > 25%, neutrophil count > 2500/ul, platelet count > 100,000
- Initial: CBC, UA, chem. panel, fecal occult blood, thoracic rads, abdominal ultrasound/rads, abdominal CT.
Therapy and Monitoring:
- Tavocept infusion over 45 mins, 30 mins into Tavocept infusion patient will begin 20 minute normal saline diuresis, followed by cisplatin infusion over 20 minutes, then another 20 minutes of normal saline diuresis.
- Treatment will be scheduled every three weeks, with a total of four treatments planned.
- Piroxicam will be administered beginning on Day 1 and continue throughout the study
- CBC and renal panel to be checked 7 days post chemo administration and prior to each subsequent therapy.
- Tumor response will be assessed on day 42 (+/- 2 days) and day 84 (+/- 2 days) with full staging including abdominal CT and US.
Benefit:
- Treatment provided at no cost to the owner. Owner to pay for fecal occult blood. This includes initial staging and follow-up CT scans and abdominal ultrasounds, blood work done at the VMTH, radiographs, chemotherapy, hospitalization and subsequent office visits at recheck exams.
Contact Faculty Person: Dr. Carolyn Henry
Pulse Palladia™ plus Lomustine for treatment of nonresectable canine MCT This study will assess the maximum tolerated dose, tolerability and adverse effect profile of combined treatment with pulse-dose toceranib and lomustine in dogs with MCT. It will also assess the objective response rate and progression-free interval in dogs with measurable MCT treated with combined pulse dose therapy.
Criteria:
- Histologically or cytologically confirmed cutaneous/subcutaneous MCT, any stage or grade, where surgical excision is not feasible or has been declined will be treated.
- All dogs will undergo complete clinical staging; CBC, Chemistry, FNA of regional lymph node, abdominal U/S +/- thoracic radiographs, FNA for c-kit mutation status using rapid PCR.
- Adequate renal, hepatic and hematologic parameters.
- Prior surgery and chemo allowable with a 2 week washout.
- No weight limit
Exclusion:
- Prior toceranib or lomustine use
Therapy:
- Minimum of 72 hours treatment with diphenhydramine, omeprazole, and prednisone prior to toceranib treatment. Toceranib administered QOD on days 1, 3 and 5 ONLY of each 21 day cycle. Lomusine on day 3, approximately 4 hours post-toceranib dosing.
Benefit:
- Free drug and blood work
- Initial staging, recheck office calls, and cost of restaging are owner’s financial responsibility.
Contact Faculty Person: Dr. Sandra Axiak
Artemisinin-Lymphoma Study-The purpose of this study is to evaluate the ability of artemisinin to down regulate genes that cause resistance to chemotherapy, and evaluate response to doxorubicin chemotherapy and artemisinin together as compared to a doxorubicin/placebo combination.
Criteria:
- Confirmed B cell multicentric, Stage IIIa or IVa lymphoma
- Complete staging including CBC, chemistry panel, flow cytometry, abdominal U/S, BMA, study echo and thoracic radiographs at first visit.
- No previous chemotherapy including prednisone.
- No cardiac, renal or hepatic insufficiency
- Request owners consent for a necropsy if patient dies or is euthanized during course of the study.
- Patients will undergo two separate lymph node biopsies, one prior to artemisinin or placebo administration and another three days later.
- Owners are expected to keep a drug log to record administration for duration of the study
Therapy:
- Twice daily oral medication of either artemisinin or placebo for the duration of the study
- Doxorubicin (30mg/m2) every 3 weeks for a total of three treatments.
- CBC prior to and one week after each scheduled chemotherapy
- Monthly rechecks for the duration of the study.
Benefit:
- Once enrolled study is fully funded. Treatment includes: Sample collection, free drug and drug administration, blood work, re-evaluating disease burden and office calls.
- Owner is responsible for diagnosis and staging, if accepted into the study owner will only pay first $300.00 of staging.
Contact Faculty Person: Dr. Jeffrey Bryan
Evaluation of immunological and tumor defining response to an IV infusion of C. novyi-NT for the treatment of melanoma, STS or select carcinomas in dogs is a study that involves an IV infusion of C. novyi-NT . An apathogenic strain of Clostridium novyi that exploits the anaerobic environment within tumors to elicit immune response following spore germination is being developed for therapy of cancer in humans and dogs. The overall goals of the proposed trial are: to better characterize effective immune response to this agent; to fully understand the interaction between the tumor hypoxic environment, spore germination, and efficacy of this agent; and to objectively identify tumor responses by means other than standard RECIST criteria in a large animal, naturally occurring model of cancer.
Criteria:
- Melanoma, oral squamous cell carcinoma, soft tissue sarcoma or cutaneous carcinoma that is resectable by a regional or smaller resection.
- Body weight > 10 kgs
- Longest tumor dimension > 2 cm.
- No evidence of metastasis
- Survival expectations of greater than six weeks
- Adequate liver and renal function; no grade 2 elevations in ALT, BUN or creatinine, persistant neutropenia/thrombocytopenia, No cardiac disease
- No antimicrobial therapy within 7 days prior to study enrollment or active bacterial infection requiring systemic therapy.
- No chemotherapy, radiation or immunotherapy within 3 weeks
- Tumor location where abscess would be catastrophic (nasal or disease which enters body cavity)
- Not pregnant or might become pregnant
- CBC, chemistry panel, UA, thoracic rads, fine-needle aspirate of draining LN by CT or U/S.
Therapy:
- Blood/tumor samples collected. CT, PET scan, two day stay in rad isolation post PET scan
- Treatment with C.novyi-NT , monitoring for 6 hrs post infusion, recheck visits on days 2-4 with PET/CT performed once evidence of early inflammation develops.
- Recheck visits on Days 7, 14, 28 and 56: CBC, Chem panel, PT/PTT, UA, flow cytometry, Tumor biopsy or surgery on day 28, CT/PET on day 28
Benefit:
- Study is fully funded, this includes initial staging, CT and PET scans, blood work , radiation isolation, office calls, tumor biopsy and surgery are covered by the study.
Contact Faculty Person: Dr.’s Jeffrey Bryan and Sandra Axiak
COTC018 Iniparib Study-Iniparib is a novel anticancer agent with demonstrated activity in early human clinical studies. The purpose of this study is to define tumor drug and metabolite levels, as well as genetic and proteomic effects of iniparib as a single agent and in combination with conventional chemotherapy. Additionally, higher doses of iniparib than currently used in human trials will be tested and may reveal additional benefits induced from a newly elucidated mechanism of action.
Criteria:
- Histologic or cytologic confirmed melanoma, head and neck carcinoma (No thyroid, HSA) , soft tissue sarcoma (amenable to serial biopsy; histology may be confirmed by pre-treatment biopsy) Must have measurable disease.
- CBC, chemistry panel, UA within 2 weeks of enrollment at COTC site.
- Patient must weigh > 10 kg’s.
- No cardiac, renal or hepatic insufficiency or clinical coagulopathy
- Owners must consent to a necropsy if patients dies or is euthanized during course of the study.
- No previous or concurrent chemotherapy, immunotherapy or radiation therapy
- Thoracic rads, +/- abd U/S, tumor measurement and pre-treatment tumor and normal tissue biopsies < 3 days before drug administration.
- Must start the study on a MONDAY!!!!
Therapy:
- Day 1-CBC, Chem panel, UA, PT/PTT, plasma and serum collection, iniparib administration, serial PK, Tumor biopsy
- Day 4- Iniparib administration, serum collection and PK
- Day 8- CBC, Chem panel, UA, PT/PTT, Plasma and serum collection, iniparib administration, carboplatin administration, serial PK, tumor biopsy
- Day 11- Iniparib administration, serum collection and PK
- Day 15- CBC, Chem panel, UA, PT/PTT, Plasma and serum collection, tumor biopsy, PK collection
- Day 22- CBC, Chem panel, UA, PT/PTT, Serum collection
Benefit:
- Once enrolled study is fully funded. Treatment includes: Sample collection, free drug and drug administration, blood work, re-evaluating disease burden and office calls.
- Owner is responsible for cost associated with diagnosis and initial blood work.
- At the study’s completion owner’s receive $1000.00 towards additional treatment at the VMTH.
Contact Faculty Person: Dr. Carolyn Henry
Evaluation of Four STA-1474 dosing regimens with MCT Heat shock protein 90 (HSP90) is a chaperone protein important in the maintenance of several client cellular proteins. HSP90 activity is upregulated in many cancer cells in an effort to maintain appropriate folding and expression of client proteins, particularly if those proteins are over expressed or mutated. STA-1474 is a novel water-soluble resorcinol-containing compound, is metabolized to STA-9090, a potent HSP90 inhibitor. This clinical trial will assess changes in gene and protein expression and function, refine the proper dosage for dogs with MCT and determine whether there is evidence of efficacy using four different dosing regimens.
Criteria:
- Histologic or cytologic diagnosis of MCT
- Normal CBC, Chem panel, UA, abdominal U/S at first visit.
- Must be at least one year of age
- No previous chemotherapy or radiation therapy, although can have received prednisone.
- Life expectancy of at least 8 weeks.
- No evidence of systemic mast cell disease
- Must be at least 3 weeks from a major surgical procedure
Therapy:
- Dogs will be randomized to receive either a single dose of STA-1474 over 1 hr, over 8 hrs, over 1 hrs for two consecutive days or over 1 hr twice/week. Tumor biopsy will be obtained prior to the first treatment and at 24 and 72 hours after last dose of STA-1474 during the first cycle. Treatment schedule will be repeated once weekly for four weeks.
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Benefit:
- Once enrolled study is mostly funded. Treatment includes: free drug and drug administration, blood work, Abd U/S, biopsies, hospitalization and additional meds.
- Office calls are owner’s responsibility.
Contact Faculty Person: Dr. Sandra Axiak
Bcl-2 Canine Lymphoma Study is an imaging study that involves injection of a radioisotope (indium) to detect the presence of the bcl-2 gene product inside tumor cells of canines with B cell lymphoma. Patients will receive three separate scans…one at enrollment; another after the patient has been in a durable remission (6-8 week range) and one at relapse. All dogs participating in this study will be placed on the University of Wisconsin-Madison lymphoma protocol. This 25 week protocol is considered the gold standard for treating canine lymphoma.
Criteria:
- B Cell lymphoma confirmed by histopathology
- Complete tumor staging including: CBC, chemistry panel, UA, thoracic radiographs, abdominal radiographs+ US, bone marrow aspirate and lymph node biopsy.
- Life expectancy of > 12 weeks, NO previous chemo other than prednisone for < 2 weeks. Adequate renal, hepatic and hematopoietic perimeters.
- Exclusion criteria: hypercalcemia and mediastinal lymph node involvement
Therapy:
- Two nuclear medicine (indium) scans- one at enrollment, one after a durable remission (6-8 weeks).
- University of Wisconsin-Madison lymphoma protocol
Benefit:
- Owner to pay $500.00 of initial staging, all nuclear medicine scans, chemotherapy and blood work cost are covered by the study.
Contact Faculty Person: Dr.’s Sandra Axiak and Mike Lewis
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