Cytotoxic T Cells and Interleukin-2 in Treating Adult Patients With Recurrent Brain Tumors
RATIONALE: Biological therapy uses different ways to stimulate the immune system and stop cancer cells from growing. Cytotoxic T cells combined with interleukin-2 may be an effective treatment for recurrent brain tumors.
PURPOSE: Phase I trial to study the effectiveness of cytotoxic T cells and interleukin-2 in treating adults with recurrent brain tumors.
Brain and Central Nervous System Tumors
Biological: therapeutic tumor infiltrating lymphocytes
Procedure: conventional surgery
|Study Design:||Primary Purpose: Treatment|
|Official Title:||Intracavitary Allogenic Cytotoxic T Lymphocytes and Human Recombinant Interleukin-2 Therapy for Recurrent Primary Brain Tumors|
|Study Start Date:||November 1994|
|Study Completion Date:||December 1999|
|Primary Completion Date:||December 1999 (Final data collection date for primary outcome measure)|
OBJECTIVES: I. Evaluate the toxicity of allogeneic cytotoxic T lymphocytes (CTL) when repeatedly instilled directly into the brain to treat recurrent primary brain tumors. II. Evaluate the response produced by allogeneic CTL and interleukin-2. III. Correlate CTL surface phenotype and degree of patient/donor HLA mismatch to response and toxicity.
OUTLINE: Surgery plus Biological Response Modifier Therapy. Tumor resection; plus intracavitary cytotoxic T lymphocytes, CTL; intracavitary Interleukin-2 (Chiron), IL-2, NSC-373364. CTL are generated in vitro by mixing irradiated patient lymphocytes (cultured with IL-2 and Monoclonal Antibody OKT 3, MOAB OKT 3, NSC-618843) with allogeneic lymphocytes and culturing the mixture with IL-2.
PROJECTED ACCRUAL: 10 patients will be treated. If severe toxicity occurs in the first 5 patients, the study will close.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002572
|United States, Colorado|
|Children's Health Center|
|Denver, Colorado, United States, 80218|
|University of Colorado Cancer Center|
|Denver, Colorado, United States, 80262|
|Veterans Affairs Medical Center - Denver|
|Denver, Colorado, United States, 80220|
|Study Chair:||Kevin O. Lillehei, MD||University of Colorado, Denver|