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Sponsors and Collaborators: |
North Central Cancer Treatment Group National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00641706 |
RATIONALE: Vorinostat and bortezomib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving vorinostat together with bortezomib may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving vorinostat together with bortezomib works in treating patients with progressive, recurrent glioblastoma multiforme.
Condition | Intervention | Phase |
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Brain and Central Nervous System Tumors |
Drug: bortezomib Drug: vorinostat Procedure: therapeutic conventional surgery |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | Phase II Study of Vorinostat (SAHA) in Combination With Bortezomib (PS-341) in Patients With Recurrent Glioblastoma Multiforme |
Estimated Enrollment: | 68 |
Study Start Date: | July 2008 |
Estimated Primary Completion Date: | August 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Stratum 1 (not undergoing surgery): Experimental
Patients receive oral vorinostat (SAHA) once daily on days 1-14 and bortezomib IV on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
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Drug: bortezomib
Vorinostat given orally. Bortezomib given IV
Drug: vorinostat
Vorinostat given orally. Bortezomib given IV
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Stratum 2 (undergoing surgery): Experimental
Patients receive oral SAHA once daily for 2 days prior to surgery and then on the day of surgery. Patients also receive bortezomib IV on the day of surgery. After receiving the 3rd dose of SAHA, patients undergo surgery to remove the tumor. Beginning at least 7 days after surgery, patients receive SAHA and bortezomib as in stratum 1.
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Drug: bortezomib
Vorinostat given orally. Bortezomib given IV
Drug: vorinostat
Vorinostat given orally. Bortezomib given IV
Procedure: therapeutic conventional surgery
Patient undergoes surgery
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OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study. Patients are stratified according to planned surgery (no [stratum 1] vs yes [stratum 2]).
Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
After completion of study therapy, patients are followed every 3 months for 2 years and then every 6 months thereafter.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed glioblastoma multiforme
Bidimensionally measurable or evaluable disease by MRI or CT scan
PATIENT CHARACTERISTICS:
No concurrent uncontrolled illness including, but not limited to, any of the following:
Not immunocompromised
PRIOR CONCURRENT THERAPY:
No more than 1 prior chemotherapy regimen* for progressive/recurrent disease (stratum 1)
More than 7 days since prior category I drugs that are generally accepted to have a risk of causing Torsades de Pointes including:
Study Chair: | Evanthia Galanis, MD | Mayo Clinic |
Responsible Party: | North Central Cancer Treatment Group ( Jan C. Buckner ) |
Study ID Numbers: | CDR0000590113, NCCTG-N0779 |
Study First Received: | March 21, 2008 |
Last Updated: | May 1, 2009 |
ClinicalTrials.gov Identifier: | NCT00641706 History of Changes |
Health Authority: | Unspecified |
adult gliosarcoma adult glioblastoma recurrent adult brain tumor adult giant cell glioblastoma |
Anticarcinogenic Agents Anti-Inflammatory Agents Glioblastoma Astrocytoma Bortezomib Vorinostat Central Nervous System Neoplasms Recurrence Protease Inhibitors Brain Neoplasms Neuroectodermal Tumors Analgesics, Non-Narcotic |
Neoplasms, Germ Cell and Embryonal Neuroepithelioma Anti-Inflammatory Agents, Non-Steroidal Peripheral Nervous System Agents Analgesics Glioma Glioblastoma Multiforme Antirheumatic Agents Gliosarcoma Nervous System Neoplasms Neoplasms, Glandular and Epithelial |
Anticarcinogenic Agents Anti-Inflammatory Agents Glioblastoma Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Neoplasms, Nerve Tissue Physiological Effects of Drugs Central Nervous System Neoplasms Neoplasms by Site Sensory System Agents Neoplasms, Germ Cell and Embryonal Therapeutic Uses Anti-Inflammatory Agents, Non-Steroidal Glioma Analgesics |
Nervous System Neoplasms Neoplasms by Histologic Type Astrocytoma Nervous System Diseases Vorinostat Bortezomib Enzyme Inhibitors Protective Agents Pharmacologic Actions Protease Inhibitors Neuroectodermal Tumors Neoplasms Analgesics, Non-Narcotic Peripheral Nervous System Agents Antirheumatic Agents |