Expired Study
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Staten Island, New York 10305


Purpose:

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.


Study summary:

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.


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


NCT ID:

NCT00003067


Primary Contact:

Study Chair
Roberta L. Hayes, PhD
Immune Therapy, LLC


Backup Contact:

N/A


Location Contact:

Staten Island, New York 10305
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: September 20, 2017

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