Brain and Central Nervous System Tumors Clinical Trial
Official title:
Adoptive Immunotherapy of Glioblastoma Multiforme With Tumor-Sensitized, Ex Vivo Activated T Lymphocytes
RATIONALE: Biological therapies use different ways to stimulate the immune system and stop
cancer cells from growing.
PURPOSE: Phase II trial to study the effectiveness of biological therapy in treating
patients with glioblastoma multiforme.
OBJECTIVES: I. Determine the time to progression in patients with glioblastoma multiforme or
anaplastic astrocytoma (primary presentation) treated with surgical resection, radiotherapy,
and T cell immunotherapy as initial therapy. II. Determine the toxic effects of this therapy
in these patients.
OUTLINE: Patients are vaccinated with irradiated, autologous tumor cells plus sargramostim
(GM-CSF) intradermally near draining lymph nodes in the groin or axillary regions. This is
then followed by 3 consecutive days of intradermal injections of GM-CSF only, directly into
the vaccine sites. Enlarged lymph nodes are then removed 7-10 days later and activated with
staphylococcal enterotoxin A (SEA) and interleukin-2 (IL-2). T cells are expanded ex vivo
over approximately 10 days. 1-2 days prior to infusion, oral cyclophosphamide is
administered as a one time dose. The lymphocyte infusion is then administered intravenously.
Based on availability, patients may receive vaccine boosts with additional injections of
irradiated autologous tumor cells thawed from the original, cryopreserved collection.
Patients are followed at 1 month and then every 2 months thereafter.
PROJECTED ACCRUAL: A maximum of 40 patients will be accrued for this study within 2 years.
;
Primary Purpose: Treatment
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