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Sponsored by: |
National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00540722 |
RATIONALE: Gossypol may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
PURPOSE: This phase II trial is studying how well gossypol works in treating patients with progressive or recurrent glioblastoma multiforme.
Condition | Intervention | Phase |
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Brain and Central Nervous System Tumors |
Drug: R-(-)-gossypol acetic acid Genetic: protein expression analysis Other: immunoenzyme technique Other: laboratory biomarker analysis |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase 2 Study of R-(-)-Gossypol (Ascenta's AT-101) in Recurrent Glioblastoma Multiforme |
Estimated Enrollment: | 56 |
Study Start Date: | January 2008 |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study.
Patients receive oral R-(-)-gossypol once daily on days 1-21. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
Patients undergo tumor tissue and blood sample collection at baseline and periodically during study for biomarker correlative studies. Archived tumor tissue samples, if available, are analyzed for Bcl-2 family protein expression (e.g., Bcl-2, Bcl-xL, MCl-1, Bax, Bak, and BH3 domain for BH3 members only) and MGMT gene methylation status. Blood samples are analyzed for apoptotic protein levels (Bcl-2) by enzyme-linked immunosorbent assay.
After completion of study therapy, patients are followed every 2 months.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed supratentorial glioblastoma multiforme
PATIENT CHARACTERISTICS:
No serious concurrent infection or medical illness that would jeopardize the ability of the patient to receive the study treatment with reasonable safety, including, but not limited to, any of the following:
No other prior malignancy except curatively treated carcinoma in situ or basal cell carcinoma of the skin
PRIOR CONCURRENT THERAPY:
United States, Alabama | |
Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham | |
Birmingham, Alabama, United States, 35294 | |
United States, Florida | |
H. Lee Moffitt Cancer Center and Research Institute at University of South Florida | |
Tampa, Florida, United States, 33612-9497 | |
United States, Georgia | |
Winship Cancer Institute of Emory University | |
Atlanta, Georgia, United States, 30322 | |
United States, Maryland | |
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | |
Baltimore, Maryland, United States, 21231-2410 | |
United States, Massachusetts | |
Massachusetts General Hospital | |
Boston, Massachusetts, United States, 02114 | |
United States, Michigan | |
Josephine Ford Cancer Center at Henry Ford Hospital | |
Detroit, Michigan, United States, 48202 | |
United States, North Carolina | |
Wake Forest University Comprehensive Cancer Center | |
Winston-Salem, North Carolina, United States, 27157-1096 | |
United States, Ohio | |
Cleveland Clinic Taussig Cancer Center | |
Cleveland, Ohio, United States, 44195 | |
United States, Pennsylvania | |
Abramson Cancer Center of the University of Pennsylvania | |
Philadelphia, Pennsylvania, United States, 19104-4283 |
Study Chair: | John Fiveash, MD | University of Alabama at Birmingham |
Responsible Party: | New Approaches to Brain Tumor Therapy ( Stuart A. Grossman ) |
Study ID Numbers: | CDR0000569405, ABTC-0702, NABTT-0702 |
Study First Received: | October 5, 2007 |
Last Updated: | July 23, 2009 |
ClinicalTrials.gov Identifier: | NCT00540722 History of Changes |
Health Authority: | United States: Food and Drug Administration |
adult giant cell glioblastoma adult gliosarcoma recurrent adult brain tumor adult glioblastoma |
Glioblastoma Astrocytoma Contraceptive Agents Contraceptive Agents, Female Central Nervous System Neoplasms Contraceptive Agents, Male Gossypol acetic acid Gossypol Recurrence Brain Neoplasms Neuroectodermal Tumors |
Neoplasms, Germ Cell and Embryonal Retinol acetate Neuroepithelioma Glioma Glioblastoma Multiforme Gliosarcoma Acetic Acid Antineoplastic Agents, Phytogenic Nervous System Neoplasms Neoplasms, Glandular and Epithelial |
Glioblastoma Contraceptive Agents Antineoplastic Agents Neoplasms, Nerve Tissue Physiological Effects of Drugs Contraceptive Agents, Female Central Nervous System Neoplasms Reproductive Control Agents Contraceptive Agents, Male Gossypol Neoplasms by Site Neoplasms, Germ Cell and Embryonal Therapeutic Uses Antispermatogenic Agents |
Glioma Nervous System Neoplasms Neoplasms by Histologic Type Astrocytoma Nervous System Diseases Gossypol acetic acid Pharmacologic Actions Neuroectodermal Tumors Neoplasms Neoplasms, Neuroepithelial Spermatocidal Agents Antineoplastic Agents, Phytogenic Neoplasms, Glandular and Epithelial |