HSPPC-96 Vaccine With Temozolomide in Patients With Newly Diagnosed GBM
Summary
The Phase 2 trial is a single-arm, open label investigation designed to evaluate safety, median survival, and immune response in patients treated with an autologous tumor-derived heat shock protein peptide-complex (HSPPC-96) administered at 25 μg per dose injected intradermally once weekly for 4 consecutive weeks and monthly following standard treatment with radiation and temozolomide.
Description
Primary objectives To evaluate the safety profile of HSPPC-96 with concurrent temozolomide in patients with newly diagnosed GBM. To evaluate median survival in patients treated with an autologous tumor derived heat shock protein peptide-complex (HSPPC-96) administered at 25 μg per dose injected intradermally once weekly for 4 consecutive weeks, then monthly, with temozolomide.
Secondary objectives Evaluate progression-free survival (PFS) from date of surgical resection. To evaluate the immunologic response to vaccine treatment
A ten patient run-in phase at UCSF will be used to evaluate the safety of the combination of vaccine and temozolomide. . Patients will receive 4 weekly injections with HSPPC-96 (at day 0, 7, 14, and 21), followed by maintenance temozolomide beginning on day 35 (+ 4 days). Maintenance TMZ will be given at 150 -200 mg/m2 body surface area for days during each 28-day cycle. HSPPC-96 will be administered monthly scheduled from vaccine administration #4, until vaccine depletion or disease progression. Immune monitoring will be completed pre-operatively, 48-hours post-surgery, prior to each vaccine administration (through administration #7, or monthly through week 16 if less than 7 vaccines), and 2 weeks after vaccine administration #4 (prior to the start of maintenance TMZ).
Study Design
Allocation: Non-Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Conditions
Brain and Central Nervous System Tumors
Intervention
HSPPC-96
Location
UCSF Department of Neurosurgery
San Francisco
California
United States
94115
Status
Recruiting
Source
University of California, San Francisco
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00905060
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Brain Neoplasms
Neoplasms of the intracranial components of the central nervous system, including the cerebral hemispheres, basal ganglia, hypothalamus, thalamus, brain stem, and cerebellum. Brain neoplasms are subdivided into primary (originating from brain tissue) and secondary (i.e., metastatic) forms. Primary neoplasms are subdivided into benign and malignant forms. In general, brain tumors may also be classified by age of onset, histologic type, or presenting location in the brain.
Neuroectodermal Tumors, Primitive
A group of malignant tumors of the nervous system that feature primitive cells with elements of neuronal and/or glial differentiation. Use of this term is limited by some authors to central nervous system tumors and others include neoplasms of similar origin which arise extracranially (i.e., NEUROECTODERMAL TUMORS, PRIMITIVE, PERIPHERAL). This term is also occasionally used as a synonym for MEDULLOBLASTOMA. In general, these tumors arise in the first decade of life and tend to be highly malignant. (From DeVita et al., Cancer: Principles and Practice of Oncology, 5th ed, p2059)
Autonomic Nervous System Diseases
Diseases of the parasympathetic or sympathetic divisions of the AUTONOMIC NERVOUS SYSTEM; which has components located in the CENTRAL NERVOUS SYSTEM and PERIPHERAL NERVOUS SYSTEM. Autonomic dysfunction may be associated with HYPOTHALAMIC DISEASES; BRAIN STEM disorders; SPINAL CORD DISEASES; and PERIPHERAL NERVOUS SYSTEM DISEASES. Manifestations include impairments of vegetative functions including the maintenance of BLOOD PRESSURE; HEART RATE; pupil function; SWEATING; REPRODUCTIVE AND URINARY PHYSIOLOGY; and DIGESTION.
Central Nervous System
The main information-processing organs of the nervous system, consisting of the brain, spinal cord, and meninges.
Central Nervous System Venous Angioma
A vascular anomaly characterized by a radial or wedge-shaped arrangement of dilated VEINS draining into a larger vein in the brain, spinal cord, or the meninges. Veins in a venous angioma are surrounded by normal nervous tissue, unlike a CENTRAL NERVOUS SYSTEM CAVERNOUS HEMANGIOMA that lacks intervening nervous tissue. Drainage of venous angioma is fully integrated with the body's venous system, therefore, in most cases there is no clinical signs and rare bleeding.
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