Cytotoxic T Cells and Interleukin-2 in Treating Adult Patients With Recurrent Brain Tumors
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Brain and Central Nervous System Tumors |
Biological: aldesleukin Biological: muromonab-CD3 Biological: therapeutic tumor infiltrating lymphocytes Procedure: conventional surgery |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | INTRACAVITARY ALLOGENEIC CYTOTOXIC T LYMPHOCYTES AND HUMAN RECOMBINANT INTERLEUKIN-2 THERAPY FOR RECURRENT PRIMARY BRAIN TUMORS |
| Estimated Enrollment: | 10 |
| Study Start Date: | November 1994 |
| Study Completion Date: | December 1999 |
| Primary Completion Date: | December 1999 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United States, Colorado | |
| Children's Health Center | |
| Denver, Colorado, United States, 80218 | |
| University of Colorado Cancer Center | |
| Denver, Colorado, United States, 80262 | |
| Veterans Affairs Medical Center - Denver | |
| Denver, Colorado, United States, 80220 | |
| Study Chair: | Kevin O. Lillehei, MD | University of Colorado, Denver |
More Information
Additional Information:
No publications provided
| Responsible Party: | University of Colorado, Denver |
| ClinicalTrials.gov Identifier: | NCT00002572 History of Changes |
| Other Study ID Numbers: | 93-0426, UCHSC-COMIRB-93426, NCI-T94-0065O |
| Study First Received: | November 1, 1999 |
| Last Updated: | February 26, 2013 |
| Health Authority: | United States: Federal Government |
Keywords provided by University of Colorado, Denver:
|
recurrent adult brain tumor adult glioblastoma adult anaplastic astrocytoma adult anaplastic oligodendroglioma |
adult mixed glioma adult giant cell glioblastoma adult gliosarcoma |
Additional relevant MeSH terms:
|
Brain Neoplasms Nervous System Neoplasms Central Nervous System Neoplasms Neoplasms by Site Neoplasms Brain Diseases Central Nervous System Diseases Nervous System Diseases Aldesleukin Interleukin-2 Muromonab-CD3 Antineoplastic Agents Therapeutic Uses |
Pharmacologic Actions Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Central Nervous System Agents Immunologic Factors Immunosuppressive Agents Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents |
ClinicalTrials.gov processed this record on May 23, 2013