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71 active trials for Kidney Cancer

A Phase 2 Study of the MET Kinase Inhibitor INC280 in Papillary Renal Cell Cancer

Background: Papillary RCC is the second most common histologic subtype of kidney cancer, accounting for approximately 10-15% of cases Type 1 papillary RCC occurs in both sporadic and hereditary forms, which are histologically identical. Non familial type 1 papillary RCC can present as both solitary renal tumors and as bilateral, multifocal disease There are no standard agents of proven efficacy for patients with advanced papillary RCC. Patients with disease localized to the kidney are managed surgically while patients with advanced/unresectable disease are usually managed in the community with VEGF pathway antagonists or mTOR inhibitors. Activating mutations of MET were identified in the germline of affected HPRC patients, who have a predilection for the development of bilateral, multifocal type 1 papillary RCC. Somatic MET mutations have been found in a subset of patients with non-inherited, sporadic papillary renal carcinoma The investigational agent INC280 is a selective MET inhibitor lacking activity against the VEGF pathway This is a proof-of-concept study using INC280 in patients with papillary RCC to test the idea that effectively blocking the HGF/MET pathway will lead to clinical activity in patients with papillary renal cell cancer Objectives: Primary Objective: -To determine the overall response rate (RECIST 1.1) in patients with papillary renal cell carcinoma treated with single agent INC280 Eligibility: Diagnosis of hereditary papillary renal carcinoma (HPRC) or sporadic papillary renal cell carcinoma (RCC) Patients with bilateral multifocal disease can have tumors localized to the kidney or have metastatic disease Patients with sporadic papillary RCC (but without multifocal disease) should have advanced disease that is considered unresectable ECOG 0-2 Measurable disease Adequate organ function No active brain metastases Prior therapy No more than 3 prior lines of systemic therapy Prior therapy with a MET inhibitor is allowed as long as the patient has not had progressive disease while receiving the agent Design: This is a phase 2 single center non-randomized trial. The study will be conducted using a Simon 2 stage minimax design. Initially 13 evaluable subjects will be recruited. If there are no responses to therapy, the study will be terminated. If there is at least 1 response an additional 7 evaluable subjects will be accrued. The two-stage minimax design is based on assuming an ineffective response rate of 5% and a targeted effective response rate of 25%. We also assume that the probability of accepting an ineffective treatment and the probability of rejecting an effective treatment are each 10%. Subjects will be dosed orally at a starting dose of 600 mg twice daily. The overall response rate (complete response + partial response) will be determined.

Bethesda, MarylandStart: January 2014
HERV-E TCR Transduced Autologous T Cells in People With Metastatic Clear Cell Renal Cell Carcinoma

Background: Gene transfer is a new cancer therapy takes white blood cells from a person and grows them in a lab. The cells are changed with a virus to attack tumor cells, then returned to the person. Researchers want to see if this therapy fights kidney cancer cells. Objective: To see if gene transfer is safe and causes tumors to shrink. Eligibility: People at least 18 years old with certain kidney cancer Design: Participants will be screened with blood and urine tests. They may have: Scans Heart, lung, and eye tests Lab tests Tumor samples taken Participants will have leukapheresis. Blood will be removed by a needle in an arm. It will go through a machine that removes white blood cells. Plasma and red cells will be returned through a needle in the participant s other arm. Participants cells will be grown in the lab and genetically changed. Participants will stay in the hospital 2-3 weeks. There they will: Get 2 chemotherapy drugs by catheter (thin plastic tube) inserted into a vein in the chest. Get the changed cells via catheter. Get a drug to increase white blood cell count and one to make the cells active. Recover for about a week. Have lab and blood tests. After leaving the hospital, participants will: Take an antibiotic for several months. Have leukapheresis. Have one- or two-day clinic visits every few weeks for 2 years, and then as determined by their doctor. These will include blood and lab tests, imaging studies, and physical exam. Participants will have follow-up checks for up to 15 years. Sponsoring Institute: National Heart, Lung, and Blood Institute ...

Bethesda, MarylandStart: July 2018