Intracavitary Allogenic Cytotoxic T Lymphocytes and Human Recombinant Interleukin-2 Therapy for Recurrent Primary Brain Tumors

University of Colorado, Denver3 sites in 1 country10 target enrollmentNovember 1994

ConditionsBrain and Central Nervous System Tumors

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Brain and Central Nervous System Tumors
Sponsor: University of Colorado, Denver
Enrollment: 10
Locations: 3
Status: Completed
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Detailed Description

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.

Registry

clinicaltrials.gov

Start Date

November 1994

End Date

December 1999

Last Updated

12 years ago

Study Type

Interventional

Sex

All