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

Phase 1
18 Years
Not Enrolling
Brain and Central Nervous System Tumors

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Trial Information

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

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.

Inclusion 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

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Kevin O. Lillehei, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Colorado, Denver


United States: Federal Government

Study ID:



Start Date:

November 1994

Completion Date:

December 1999

Related Keywords:

  • Brain and Central Nervous System Tumors
  • recurrent adult brain tumor
  • adult glioblastoma
  • adult anaplastic astrocytoma
  • adult anaplastic oligodendroglioma
  • adult mixed glioma
  • adult giant cell glioblastoma
  • adult gliosarcoma
  • Brain Neoplasms
  • Nervous System Neoplasms
  • Central Nervous System Neoplasms



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