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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]).
Tumor tissue samples are collected at baseline and during surgery (stratum 2) for correlative laboratory studies. Tissue samples are analyzed for baseline total and phosphorylated AKT and p27^KIp1 expression by IHC. Tissue samples from patients in stratum 2 are also analyzed for histone acetylation status; markers of proteasome inhibition; total and phosphorylated Bax expression by IHC; and gene expression profiles.
After completion of study therapy, patients are followed every 3 months for 2 years and then every 6 months for up to 13 years.
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 |
Study ID Numbers: | CDR0000590113, NCCTG-N0779 |
Study First Received: | March 21, 2008 |
Last Updated: | January 15, 2009 |
ClinicalTrials.gov Identifier: | NCT00641706 |
Health Authority: | Unspecified |
adult gliosarcoma adult glioblastoma recurrent adult brain tumor adult giant cell glioblastoma |
Glioblastoma Astrocytoma Bortezomib Vorinostat Central Nervous System Neoplasms Recurrence Brain Neoplasms Neuroectodermal Tumors |
Glioblastoma multiforme Neoplasms, Germ Cell and Embryonal Neuroepithelioma Glioma Gliosarcoma Nervous System Neoplasms Neoplasms, Glandular and Epithelial |
Anticarcinogenic Agents Anti-Inflammatory Agents Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Neoplasms, Nerve Tissue Nervous System Diseases Physiological Effects of Drugs Enzyme Inhibitors Protective Agents Pharmacologic Actions Protease Inhibitors |
Neoplasms Neoplasms by Site Analgesics, Non-Narcotic Sensory System Agents Therapeutic Uses Anti-Inflammatory Agents, Non-Steroidal Analgesics Peripheral Nervous System Agents Antirheumatic Agents Neoplasms, Neuroepithelial Central Nervous System Agents |