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	Treatment or Intervention	Phase
adult anaplastic oligodendroglioma adult glioblastoma multiforme adult anaplastic astrocytoma Mixed Gliomas recurrent adult brain tumor	Drug: interleukin-2  Drug: interleukin-2/tumor infiltrating lymphocytes  Drug: monoclonal antibody OKT3  Drug: tumor infiltrating lymphocytes	Phase I

Further Study Details: 

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.

PROTOCOL 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.

Ages Eligible for Study:  18 Years and above

Criteria

PROTOCOL ENTRY 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

--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

--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

Colorado
      Children's Health Center, Denver,  Colorado,  80218,  United States
      University of Colorado Cancer Center, Denver,  Colorado,  80262,  United States
      Veterans Affairs Medical Center - Denver, Denver,  Colorado,  80220,  United States

Study chairs or principal investigators

Kevin Owen Lillehei,  Study Chair,  University of Colorado Cancer Center   

Study ID Numbers:  CDR0000063621; UCHSC-COMIRB-93426; NCI-T94-0065O
Record last reviewed:  July 2004
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00002572
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08