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

Brain and Central Nervous System Tumors Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002572
• Other study ID #: 93-0426.cc
• Secondary ID: UCHSC-COMIRB-934
• Status: Completed
• Phase: Phase 1
• First received: November 1, 1999
• Last updated: May 28, 2013
• Start date: November 1994
• Est. completion date: December 1999

Study information

• Verified date: July 2000
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: December 1999
• Est. primary completion date: December 1999
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

DISEASE CHARACTERISTICS: Kernohan Grade III/IV primary malignant brain tumor that has failed conventional surgical resection and radiotherapy Evidence of recurrent tumor on gadolinium-enhanced MRI following completion of radiotherapy (minimum 5,000 cGy for adults) required The following histologies are eligible: Anaplastic astrocytoma Anaplastic oligodendroglioma Glioblastoma multiforme Mixed anaplastic glioma Surgical resection of progressing brain tumor feasible No evidence of tumor extending across the midline from one hemisphere to the other No multifocal tumor or leptomeningeal spread

PATIENT CHARACTERISTICS: Age: Over 18 Performance status: Karnofsky 60-100% Life expectancy: At least 2 months Hematopoietic: WBC greater than 2,000 Platelets greater than 100,000 Hct at least 28% Hepatic: Bilirubin less than 1.5 mg/dl Renal: Creatinine less than 1.5 mg/dl Cardiovascular: No major cardiovascular problems Pulmonary: No major pulmonary problems Other: Seronegative for HTLV/HIV, syphilis, and hepatitis B and C No concurrent systemic infection Ability to maintain proper nutrition (orally or intravenously) during the study period required No pregnant women

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: More than 4 weeks since systemic chemotherapy (6 weeks since carmustine), with the WBC increasing on 2 consecutive determinations at least 3 days apart Endocrine therapy: Not specified Radiotherapy: At least 8 weeks since radiotherapy Surgery: See Disease Characteristics

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Brain and Central Nervous System Tumors
• Brain Neoplasms
• Central Nervous System Neoplasms
• Nervous System Neoplasms

Intervention

Biological:
• aldesleukin

• muromonab-CD3

• therapeutic tumor infiltrating lymphocytes

Procedure:
• conventional surgery

Locations

Country	Name	City	State
United States	Children's Health Center	Denver	Colorado
United States	University of Colorado Cancer Center	Denver	Colorado
United States	Veterans Affairs Medical Center - Denver	Denver	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
University of Colorado, Denver	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States,