- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00002572
Cytotoxic T Cells and Interleukin-2 in Treating Adult Patients With Recurrent Brain Tumors
Intracavitary Allogenic Cytotoxic T Lymphocytes and Human Recombinant Interleukin-2 Therapy for Recurrent Primary Brain Tumors
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.
Study Overview
Status
Conditions
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 Type
Enrollment (Anticipated)
Phase
- Phase 1
Contacts and Locations
Study Locations
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Colorado
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Denver, Colorado, United States, 80220
- Veterans Affairs Medical Center - Denver
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Denver, Colorado, United States, 80262
- University of Colorado Cancer Center
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Denver, Colorado, United States, 80218
- Children's Health Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: Kevin O. Lillehei, MD, University of Colorado, Denver
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Neoplasms
- Neoplasms by Site
- Brain Neoplasms
- Nervous System Neoplasms
- Central Nervous System Neoplasms
- Physiological Effects of Drugs
- Anti-Infective Agents
- Antiviral Agents
- Anti-HIV Agents
- Anti-Retroviral Agents
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Aldesleukin
- Muromonab-CD3
Other Study ID Numbers
- 93-0426.cc
- UCHSC-COMIRB-93426
- NCI-T94-0065O
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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