Cytotoxic T Cells and Interleukin-2 in Treating Adult Patients With Recurrent Brain Tumors
|ClinicalTrials.gov Identifier: NCT00002572|
Recruitment Status : Completed
First Posted : July 29, 2004
Last Update Posted : May 30, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Brain and Central Nervous System Tumors||Biological: aldesleukin Biological: muromonab-CD3 Biological: therapeutic tumor infiltrating lymphocytes Procedure: conventional surgery||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Official Title:||Intracavitary Allogenic Cytotoxic T Lymphocytes and Human Recombinant Interleukin-2 Therapy for Recurrent Primary Brain Tumors|
|Study Start Date :||November 1994|
|Actual Primary Completion Date :||December 1999|
|Actual Study Completion Date :||December 1999|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002572
|United States, Colorado|
|Children's Health Center|
|Denver, Colorado, United States, 80218|
|Veterans Affairs Medical Center - Denver|
|Denver, Colorado, United States, 80220|
|University of Colorado Cancer Center|
|Denver, Colorado, United States, 80262|
|Study Chair:||Kevin O. Lillehei, MD||University of Colorado, Denver|