Biological Therapy in Treating Patients With Primary or Advanced Glioma
|ClinicalTrials.gov Identifier: NCT00003067|
Recruitment Status : Suspended
First Posted : January 27, 2003
Last Update Posted : February 9, 2009
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.
|Condition or disease||Intervention/treatment||Phase|
|Brain and Central Nervous System Tumors||Biological: aldesleukin Biological: lymphokine-activated killer cells||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Official Title:||Intracavitary Interleukin-2 (IL-2) and Lymphokine-Activated Killer (LAK) Cell Therapy for Malignant Gliomas|
|Study Start Date :||July 1997|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003067
|United States, New York|
|Staten Island University Hospital|
|Staten Island, New York, United States, 10305|
|Study Chair:||Roberta L. Hayes, PhD||Immune Therapy, LLC|