|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | North Central Cancer Treatment Group |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00731731 |
Purpose
RATIONALE: Vorinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving vorinostat together with temozolomide and radiation therapy may kill more tumor cells.
PURPOSE: This phase I/II trial is studying the side effects and best dose of vorinostat when given together with temozolomide and radiation therapy and to see how well they work in treating patients with newly diagnosed glioblastoma multiforme.
| Condition | Intervention | Phase |
|---|---|---|
|
Brain and Central Nervous System Tumors Cognitive/Functional Effects |
Drug: temozolomide Drug: vorinostat Procedure: adjuvant therapy Procedure: cognitive assessment Radiation: radiation therapy |
Phase I Phase II |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | Phase I/II Study of Vorinostat (Suberoylanilide Hydroxamic Acid [SAHA]), Temozolomide, and Radiation Therapy in Patients With Newly Diagnosed Glioblastoma |
| Estimated Enrollment: | 132 |
| Study Start Date: | July 2009 |
| Estimated Primary Completion Date: | October 2009 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
Tertiary
OUTLINE: This is a multicenter, phase I, dose-escalation study of vorinostat followed by a phase II study.
Patients undergo radiotherapy and receive oral vorinostat once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Patients also receive oral temozolomide once daily on days 1-42. Beginning 4-6 weeks later, patients receive oral vorinostat once daily on days 1-7 and 15-21 and oral temozolomide once daily on days 1-5. Treatment with vorinostat and temozolomide repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Patients enrolled in phase II and those who are treated at the maximum tolerated dose in phase I submit tumor tissue samples for correlative laboratory studies. Studies include assessment of histone acetylation status by immunohistochemistry; gene expression profiling; and assessment of MGMT methylation status by polymerase chain reaction.
Patients enrolled in phase II and those who are treated at the maximum tolerated dose in phase I complete a neurocognitive assessment prior to, during, and after completion of study therapy. The assessment includes the Hopkins Verbal Learning Test (HVLT-R) (Revised), the Controlled Oral Word Association test from the Multilingual Aphasia Examination (COWA), the Trail Making Test A: Visual scanning speed, and the Trail Making Test B: Divided attention.
After completion of study treatment, patients are followed every 3 months for 2 years and then every 6 months for 1 years.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
Contacts and Locations| United States, Alabama | |
| UAB Comprehensive Cancer Center | Recruiting |
| Birmingham, Alabama, United States, 35294 | |
| Contact: Clinical Trials Office - UAB Comprehensive Cancer Center 205-934-0309 | |
| United States, California | |
| Jonsson Comprehensive Cancer Center at UCLA | Recruiting |
| Los Angeles, California, United States, 90095-1781 | |
| Contact: Clinical Trials Office - Jonsson Comprehensive Cancer Center a 888-798-0719 | |
| UCSF Helen Diller Family Comprehensive Cancer Center | Recruiting |
| San Francisco, California, United States, 94115 | |
| Contact: Clinical Trials Office - UCSF Helen Diller Family Comprehensi 877-827-3222 | |
| United States, Florida | |
| Mayo Clinic - Jacksonville | Recruiting |
| Jacksonville, Florida, United States, 32224 | |
| Contact: Clinical Trials Office - All Mayo Clinic Locations 507-538-7623 | |
| H. Lee Moffitt Cancer Center and Research Institute at University of South Florida | Recruiting |
| Tampa, Florida, United States, 33612-9497 | |
| Contact: Clinical Trials Office - H. Lee Moffitt Cancer Center and Rese 800-456-7121 canceranswers@moffitt.org | |
| United States, Georgia | |
| Winship Cancer Institute of Emory University | Recruiting |
| Atlanta, Georgia, United States, 30322 | |
| Contact: Jeffrey J. Olson, MD 404-778-5770 | |
| United States, Maryland | |
| Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Recruiting |
| Baltimore, Maryland, United States, 21231-2410 | |
| Contact: Clinical Trials Office - Sidney Kimmel Comprehensive Cancer Ce 410-955-8804 jhcccro@jhmi.edu | |
| Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office | Recruiting |
| Bethesda, Maryland, United States, 20892-1182 | |
| Contact: Clinical Trials Office - Warren Grant Magnusen Clinical Center 888-NCI-1937 | |
| United States, Massachusetts | |
| Massachusetts General Hospital | Recruiting |
| Boston, Massachusetts, United States, 02114 | |
| Contact: Clinical Trials Office - Massachusetts General Hospital 877-726-5130 | |
| United States, Michigan | |
| Josephine Ford Cancer Center at Henry Ford Hospital | Recruiting |
| Detroit, Michigan, United States, 48202 | |
| Contact: Tom Mikkelsen, MD 313-916-8641 nstom@neuro.hfh.edu | |
| United States, New York | |
| Memorial Sloan-Kettering Cancer Center | Recruiting |
| New York, New York, United States, 10065 | |
| Contact: Lauren E. Abrey, MD 212-639-5122 abreyl@mskcc.org | |
| United States, North Carolina | |
| Duke University Medical Center | Recruiting |
| Durham, North Carolina, United States, 27710 | |
| Contact: David A. Reardon, MD 919-684-5301 reard003@mc.duke.edu | |
| Wake Forest University Comprehensive Cancer Center | Recruiting |
| Winston-Salem, North Carolina, United States, 27157-1096 | |
| Contact: Clinical Trials Office - Wake Forest University Comprehensive 336-713-6771 | |
| United States, Ohio | |
| Cleveland Clinic Taussig Cancer Center | Recruiting |
| Cleveland, Ohio, United States, 44195 | |
| Contact: Clinical Trials Office - Cleveland Clinic Taussig Cancer Cente 866-223-8100 | |
| United States, Pennsylvania | |
| Abramson Cancer Center of the University of Pennsylvania | Recruiting |
| Philadelphia, Pennsylvania, United States, 19104-4283 | |
| Contact: Clinical Trials Office - Abramson Cancer Center of the Univers 800-474-9892 | |
| UPMC Cancer Centers | Recruiting |
| Pittsburgh, Pennsylvania, United States, 15232 | |
| Contact: Clinical Trials Office - UPMC Cancer Centers 412-647-8073 | |
| United States, Texas | |
| M. D. Anderson Cancer Center at University of Texas | Recruiting |
| Houston, Texas, United States, 77030-4009 | |
| Contact: Clinical Trials Office - M. D. Anderson Cancer Center at the U 713-792-3245 | |
| United States, Wisconsin | |
| University of Wisconsin Paul P. Carbone Comprehensive Cancer Center | Recruiting |
| Madison, Wisconsin, United States, 53792-6164 | |
| Contact: Clinical Trials Office - University of Wisconsin Paul P. Carbo 608-262-5223 | |
| Study Chair: | Evanthia Galanis, MD | Mayo Clinic |
| Study Chair: | Patrick Y. Wen, MD | Dana-Farber Cancer Institute |
More Information
| Responsible Party: | Jan C. Buckner, North Central Cancer Treatment Group |
| ClinicalTrials.gov Identifier: | NCT00731731 History of Changes |
| Other Study ID Numbers: | CDR0000609743, NCCTG-N0874, ABTC 0902 |
| Study First Received: | August 8, 2008 |
| Last Updated: | March 23, 2011 |
| Health Authority: | Unspecified |
|
cognitive/functional effects adult glioblastoma adult gliosarcoma adult giant cell glioblastoma |
|
Glioblastoma Nervous System Neoplasms Central Nervous System Neoplasms Astrocytoma Glioma Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms by Site |
Nervous System Diseases Temozolomide Dacarbazine Vorinostat Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Histone Deacetylase Inhibitors Enzyme Inhibitors |