Sunitinib and Irradiated Donor Lymphocytes in Treating Patients With Metastatic Kidney Cancer
RATIONALE: Sunitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Infusing irradiated donor lymphocytes into the patient may help the patient's immune system kill tumor cells. Giving sunitinib together with irradiated donor lymphocytes may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving sunitinib together with irradiated donor lymphocytes works in treating patients with metastatic kidney cancer.
|Kidney Cancer||Biological: therapeutic allogeneic lymphocytes Drug: sunitinib malate||Phase 2|
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Phase II Study of Sunitinib Plus Extended Courses of Irradiated Allogeneic Lymphocytes for Patients With Renal Cell Carcinoma (SPECIAL Trial)|
- Progression-free survival [ Time Frame: Treatment start date to date of progression ]
- Rates and kinetics of clinical/radiographic response [ Time Frame: Treatment start date to best response ]
- Toxicity as assessed by NCI CTCAE v3.0 [ Time Frame: Treatment start date to off study ]
- Stable disease at 6 months [ Time Frame: Treatment start date to 6 months ]
- Overall survival [ Time Frame: Treatment start date to date of death ]
|Study Start Date:||February 2009|
|Study Completion Date:||February 22, 2014|
|Primary Completion Date:||February 22, 2014 (Final data collection date for primary outcome measure)|
|Experimental: Sunitinib plus Irradiated Allogeneic Lymphocytes||
Biological: therapeutic allogeneic lymphocytes
Patients with a partially HLA-matched family member who can serve as a hematopoietic stem cell transplant donor will receive partially HLA-matched irradiated donor lymphocytes approximately every 8 weeks depending upon responseDrug: sunitinib malate
Sunitinib will be administered orally at a dose of 50 mg qd for 4 consecutive weeks followed by 2 weeks off for every cycle.
- Determine progression-free survival of patients with metastatic clear cell renal cell carcinoma treated with sunitinib and irradiated allogeneic lymphocytes.
- Determine rates and kinetics of clinical/radiographic response in these patients.
- Determine toxicities associated with treatment in these patients.
- Assess stable disease at 6 months in these patients.
- Assess overall survival of these patients.
OUTLINE: Patients receive oral sunitinib malate once daily for 4 weeks. Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity. Beginning with course 2 of sunitinib malate, patients also receive irradiated allogeneic lymphocytes IV over 1 hour every 8-16 weeks for up to 6 infusions in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically for 60 days.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00853125
|United States, New Jersey|
|Rutgers Cancer Institute of New Jersey|
|New Brunswick, New Jersey, United States, 08903|
|Principal Investigator:||Roger Strair, MD, PhD||Rutgers Cancer Institute of New Jersey|