Intracavitary Allogenic Cytotoxic T Lymphocytes and Human Recombinant Interleukin-2 Therapy for Recurrent Primary Brain Tumors
aldesleukin
+ muromonab-CD3
+ therapeutic tumor infiltrating lymphocytes
Brain Diseases+16
+ Central Nervous System Diseases
+ Neoplasms
Treatment Study
Summary
Study start date: November 1, 1994
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.10 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
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 Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 3 locations
Veterans Affairs Medical Center - Denver
Denver, United StatesUniversity of Colorado Cancer Center
Denver, United States