Oncology - Clinical Studies
Clinical study to assess the clinical safety and maximally tolerated dose of a new orally administered chemotherapy drug under development for dogs with lymphoma.
- Description: This sponsored clinical study seeks to assess the clinical safety and maximally tolerated dose of a new orally administered chemotherapy drug under development for dogs with lymphoma. Dogs with suspected or confirmed lymphoma will be screened and staged for disease. Dogs confirmed with B-cell lymphoma, and who meet patient eligibility criteria, will be enrolled in the study. Enrolled dogs will be treated with study medication and observed in the hospital for 2 days. Patients will be discharged, and owners will receive a supply of study medication to administer to their dog once daily by mouth. Patients will return to the hospital once weekly for 4 weeks.
- Eligibility: Referred patients will receive full staging and screening at NC State.
- Dogs must satisfy the following criteria:
- diagnosed with B-cell lymphoma, substage "a" (not clinically sick)
- Evidence of multiple lymph node enlargement
- Dogs with the following conditions will be excluded:
- T-cell lymphoma
- B-cell lymphoma subclassified as "b" with systemic signs of illness
- Dogs who have previously received chemotherapy for lymphoma
- Dogs previously treated with corticosteroids within 14 days of enrollment, or long-acting corticosteroids within 60 days of enrollment
- currently receiving cardiac, anticonvulsant, or behavioral medication
- diabetes mellitus or other uncontrolled endocrine disorders
- existing renal, cardiovascular, hepatic, or gastrointestinal tract dysfunction
- Dogs must satisfy the following criteria:
- Financial incentive: Study funding will cover all enrollment and study related examinations, blood and urine tests, radiographs, ultrasound, electrocardiograms, sample collections (including lymph node biopsy), anesthesia, hospitalization, and study medications for qualifying patients. In addition, participants will receive $1000 credit towards follow-up oncology care for all patients completing the study or removed per the study design.
- Who to contact: CCMTR Clinical Studies Core, Dr. Kim Chappell 919.513.6352, ccmtr_csc@ncsu.edu, or Oncology Service, Dr. Marlene Hauck 919.513.6690.
The Impact of the Multi-Kinase Inhibitor Palladia™ on Angiogenesis and Survival following Amputation and Carboplatin Chemotherapy in Canine Osteosarcoma
Description: Osteosarcoma is the most common bone cancer in dogs. Tumors are locally invasive and have a high rate of metastasis (spread to other places in the body). We are evaluating the use of a novel approach to the treatment of osteosarcoma involving the use of an oral medication (Palladia™) following standard of care treatment (amputation and four cycles of carboplatin chemotherapy). Palladia™ has the ability to disrupt the blood supply to tumor cells and may therefore help delay or prevent the onset of metastasis.
Eligibility: Dogs with appendicular osteosarcoma with no radiographic evidence of pulmonary metastasis following amputation and four cycles of carboplatin chemotherapy.
Treatment: Two weeks following completion of carboplatin chemotherapy dogs will begin Palladia™ and treatment will be continued until disease progression
Financial incentive: The study will cover the costs of Palladia™ and blood work associated with drug monitoring. Clients will be responsible for costs associated with initial evaluation, amputation, and every other month thoracic radiographs.
Who to contact: Study coordinator, Ms. Julie Osborne, RVT, at 919.513.6812 or via email at julie_osborne@ncsu.edu.
The Impact of the Multi-Kinase Inhibitor Palladia™ on Angiogenesis and Survival in Canine Osteosarcoma
Description: Osteosarcoma is the most common bone cancer in dogs. Tumors are locally invasive and have a high rate of metastasis. We are evaluating the use of a novel approach to the treatment of ostesarcoma using the an oral medication, Palladia™, following amputation. Palladia™ has the ability to disrupt the blood supply to tumor cells and may therefore help delay or prevent the onset of metastasis.
Eligibility: Dogs with appendicular osteosarcoma with no radiographic evidence of pulmonary metastasis undergoing amputation
Treatment: 5 days following amputation dogs will begin Palladia™ and treatment will be continued until disease progression
Financial incentive: The study will cover the costs of Palladia™ and blood work associated with drug monitoring. Clients will be responsible for costs associated with initial evaluation, amputation, and every other month thoracic radiographs.
Who to contact: Study coordinator, Ms. Julie Osborne, RVT, at 919.513.6812 or via email at julie_osborne@ncsu.edu.
Pulse Palladia plus CCNU for the Treatment of Measurable Canine Mast Cell Tumors
Description: Mast cell tumors are one of the most common skin tumors in dogs. Conventional treatment consists of surgery +/-radiation therapy. In some situations, however, tumors are highly malignant, inoperable and/or have spread to other places in the body, making systemic chemotherapy a worthwhile part of treatment. To date, studies have focused on the use of single or combined chemotherapy protocols consisting of prednisone, vinblastine, and CCNU, with response rates of approximately 20-45% lasting for a few to several months. More recently, a new drug called Palladia has been developed specifically for the treatment of canine mast cell tumors. This drug works in a unique way, targeting a specific mutation present in mast cell tumors. Response rates to Palladia are approximately 40-45%. The goal of the current study is to evaluate the combination of conventional CCNU chemotherapy with Palladia in hopes of improving outcome for dogs with mast cell tumors. This study will also determine the optimal dosage of combined CCNU and Palladia in dogs.
Eligibility: Dogs with measurable mast cell tumors.
Financial incentive: The study will provide the chemotherapy drugs CCNU and Palladia and will cover the majority of costs of blood work performed as part of treatment monitoring. Clients will be responsible for costs associated with initial evaluation, recheck visit evaluations, and any concurrent medications.
Who to contact: Study coordinator, Ms. Julie Osborne, RVT, at 919.513.6812 or via email at julie_osborne@ncsu.edu
Impact of Palladia™ on Canine Osteosarcoma
Description: Osteosarcoma is the most common bone cancer in dogs. Tumors are locally invasive and have a high rate of metastasis. We are evaluating the use of a novel approach to the treatment of ostesarcoma using an oral medication, Palladia™, following amputation. Palladia™ has the ability to disrupt the blood supply to tumor cells and may therefore help delay or prevent the onset of metastasis.
Eligibility: Dogs with appendicular osteosarcoma with no radiographic evidence of pulmonary metastasis undergoing amputation
Treatment: 5 days following amputation dogs will begin Palladia™ and treatment will be continued until disease progression
Financial incentive: The study will cover the costs of Palladia™ and blood work associated with drug monitoring. Clients will be responsible for costs associated with initial evaluation, amputation, and every other month thoracic radiographs (approx. $150/visit).
Who to contact: Study coordinator, Ms. Julie Osborne, RVT, at 919.513.6812 or via email at julie_osborne@ncsu.edu
Feline Fibrosarcoma Study
Description: Injection-site sarcomas are devastating tumors in cats, which occur at sites of a previous injection or vaccination. Vaccines were first suspected as an underlying cause of these sarcomas, but other types of injections also appear to cause the tumors. The laboratory of Dr. Marlene Hauck is evaluating the genetic changes that are seen in these tumors along with genetics changes seen in spontaneously arising sarcomas and injection site reactions. Our goal is to identify potential targets for treatment and prevention to improve the outcome for cats with sarcomas. A biopsy sample is obtained from the sarcoma for the genetic analysis. This can occur at NCSU or at the primary veterinarian.
Eligibility: Any cat diagnosed with an injection-site sarcoma or spontaneously arising sarcoma. The biopsy must be place immediately in a RNA preserving solution.
Financial Incentive: There is no financial incentive to take part in this study. We are happy to ship the RNA preservative solution to any veterinarian performing a biopsy on a cat suspected of one of the above conditions.
Who to contact: please call 919.513.8276 or email Julie Fisher.
Canine Soft Tissue Sarcoma Study
Description: Soft tissue sarcomas are the most common type of solid tumors in dogs. They are locally invasive tumors with a high local recurrence rate. The metastasis rate is around 25% depending on the tumor type and grade. The laboratory of Dr. Marlene Hauck is evaluating the genetic changes that are seen soft tissue sarcomas that metastasize versus ones that do not. Our goal is to identify a gene or protein “signature” to identify those tumors most likely to metastasize, and ultimately to improve the outcome for dogs with soft tissue sarcomas. A biopsy sample is obtained from the sarcoma for the genetic analysis. This can occur at NCSU or at the primary veterinarian.
Eligibility: Dogs diagnosed with the following types of soft tissue sarcomas: fibrosarcomas, hemangiopericytomas, peripheral nerve sheath tumors, liposarcomas, leiomyosarcomas, rhabdomyosarcomas, myxosarcomas and undifferentiated sarcomas.
Financial Incentive: There is no financial incentive to take part in this study.
Who to contact: please call 919.513.8276 or email Julie Fisher.