Biological Therapy in Treating Patients With Primary or Advanced Glioma
Status and phase
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Details and patient eligibility
About
RATIONALE: Biological therapies use different ways to stimulate the immune system and stop cancer cells from growing. Interleukin-2 may stimulate a person's white blood cells to kill cancer cells in patients with primary or advanced glioma.
PURPOSE: Clinical trial to study the effectiveness of biological therapy with interleukin-2 and lymphokine-activated killer cells in treating patients who have primary, recurrent, or refractory malignant glioma.
Full description
OBJECTIVES:
- Confirm the antitumor efficacy of intracavitary interleukin-2 plus autologous lymphokine-activated killer cells in patients with primary, recurrent or refractory malignant gliomas.
- Determine whether the induction of a regional, intracavitary, eosinophilia is a prognosticator of response to immunotherapy and long term survival in these patients.
OUTLINE: Patients receive cytoreductive tumor surgery and/or biopsy and implantation of intracavitary Ommaya reservoir prior to therapy induction.
Patients undergo outpatient leukapheresis on day -4 or -5, and cells are incubated ex vivo with interleukin-2 (IL-2). Lymphokine-activated killer (LAK) cells and IL-2 are infused on day 1. Bolus infusions of low-dose IL-2 are administered on days 3, 5, 8, 10, and 12, followed by a rest period on days 13-24. The course is repeated on day 25 starting with leukapheresis. Therapy courses are repeated for up to 1 year for stable disease or response to therapy. Maintenance doses repeat every 4-6 months thereafter.
Disease restaging is done every 8-12 weeks.
PROJECTED ACCRUAL: A total of 30 patients per year will be enrolled.
Sex
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Volunteers
Inclusion and exclusion criteria
DISEASE CHARACTERISTICS:
-
Histologically or radiographically proven primary, recurrent, or refractory malignant gliomas (glioblastoma, anaplastic astrocytoma, and mixed anaplastic glioma)
- Must be a candidate for neurosurgical biopsy or tumor debulking
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance Status:
- Karnofsky 60-100%
Life Expectancy:
- Greater than 4 months
Hematopoietic:
- Granulocytes greater than 1,500/mm^3
- Platelet count greater than 50,000/mm^3
- PT and PTT within normal limits
Hepatic:
- Bilirubin no greater than 1.5 times upper limit of normal
Renal:
- Creatinine less than 1.5 mg/dL
- Creatinine clearance greater than 60 mL/min
Cardiovascular:
- No congestive heart failure
- No coronary artery disease
- No serious cardiac arrhythmias
- No prior myocardial infarction
Pulmonary:
- No major pulmonary problems
Other:
- No history of neurologic disease (except related to brain tumor)
- No psychosis
- No impaired cognitive function
- No significant concurrent medical illness
- No active infection requiring antibiotic therapy
- Not pregnant
- Negative pregnancy test
- Fertile patients must use effective contraception
- Adequate peripheral veins to permit leukapheresis, or placement of indwelling central vascular access device
- No hepatitis B or C
- HIV negative
- No prior autoimmune disease
- Allergy to gentamicin is allowed
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- At least 6 weeks since prior immunotherapy and recovered
- No concurrent immunotherapy
Chemotherapy:
- At least 4 weeks since prior chemotherapy (6 weeks for carmustine) and recovered
- No concurrent chemotherapy
Endocrine therapy:
- Reduction or elimination of corticosteroids
- Not greater than 0.15 mg/kg/day dexamethasone equivalent
Radiotherapy:
- At least 6 weeks since prior radiotherapy and recovered
- No concurrent radiotherapy
Surgery:
- Prior surgery is allowed
Other:
- Concurrent therapy with acetaminophen, anticonvulsant agents, and headache pain medications is allowed
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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