Cytotoxic T Cells and Interleukin-2 in Treating Adult Patients With Recurrent Brain Tumors

Phase 1

Completed

• Conditions: Brain and Central Nervous System Tumors

• Registration Number: NCT00002572
• Lead Sponsor: University of Colorado, Denver

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.

Study Timeline

• Study Start: 1994-11
• Study First Submitted: 1999-11-01
• Primary Completion: 1999-12
• Study Completion: 1999-12
• Status Verified: 2000-07
• Study First Submitted QC: 2004-07-28
• Study First Posted: 2004-07-29
• Last Update Submitted: 2013-05-28
• Last Update Posted: 2013-05-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (3)

Children's Health Center; 🇺🇸 Denver, Colorado, United States

Veterans Affairs Medical Center - Denver; 🇺🇸 Denver, Colorado, United States

University of Colorado Cancer Center; 🇺🇸 Denver, Colorado, United States