Biological Therapy in Treating Patients With Metastatic Cancer
|ClinicalTrials.gov Identifier: NCT00002733|
Recruitment Status : Completed
First Posted : July 1, 2004
Last Update Posted : May 11, 2011
RATIONALE: Biological therapies use different ways to stimulate the immune system and stop cancer cells from growing. Combining different types of biological therapies, including interferon alfa, interleukin-2, and tumor infiltrating lymphocytes, may kill more cancer cells.
PURPOSE: Phase II trial to study the effectiveness of biological therapies, including interferon alfa, interleukin-2, and tumor infiltrating lymphocytes, in treating patients with metastatic cancer.
|Condition or disease||Intervention/treatment||Phase|
|Kidney Cancer Melanoma (Skin) Unspecified Adult Solid Tumor, Protocol Specific||Biological: aldesleukin Biological: recombinant interferon alfa Biological: therapeutic tumor infiltrating lymphocytes Drug: cimetidine||Phase 2|
OBJECTIVES: I. Determine the response rate and failure-free survival in patients with metastatic cancer (preferably melanoma or renal cell) treated with autologous tumor infiltrating lymphocytes (TIL), interferon alfa (IFN-A), and interleukin-2 (IL-2). II. Describe the toxic effects and costs associated with this therapy to assess risk benefit and cost benefit. III. Assess the relative value of administering low- or high-dose TIL, as well as the value of administering IFN-A before TIL, IL-2 with TIL, or cimetidine with TIL.
OUTLINE: This is a multicenter study. Patients are stratified according to center, tumor infiltrating lymphocyte (TIL) dose (low vs high), and medical condition suitable for interferon alfa (IFN-A)/interleukin-2 (IL-2) (yes vs no). Patients are assigned to one of two treatment regimens based on entry criteria. Regimen A (preferred): Patients meeting the preferred entry criteria receive IFN-A subcutaneously on days 1-4, TIL expanded in vitro with IL-2 IV on day 5, and IL-2 IV continuously over 72 hours following TIL infusion. Regimen B: All other patients receive TIL infusion once followed by oral cimetidine every 6 hours for 4 weeks. Treatment repeats in both regimens every 3-6 weeks in the absence of disease progression and according to TIL availability. Patients are followed every 6 months.
PROJECTED ACCRUAL: A total of 20-30 patients with melanoma and 20-30 patients with renal cell carcinoma will be accrued for this study.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Official Title:||ALPHA INTERFERON, TUMOR INFILTRATING LYMPHOCYTES, AND INTERLEUKIN-2 IN THE TREATMENT OF CANCER|
|Study Start Date :||January 1996|
|Primary Completion Date :||January 2000|
|Study Completion Date :||January 2000|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002733
|United States, California|
|Hoag Memorial Hospital Presbyterian|
|Newport Beach, California, United States, 92658|
|Study Chair:||Robert O. Dillman, MD, FACP||Cancer Biotherapy Research Group|