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Sponsored by: |
National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00390403 |
RATIONALE: Drugs used in chemotherapy, such as gossypol and 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. Gossypol may help temozolomide work better by making tumor cells more sensitive to the drug. Gossypol may also make tumor cells more sensitive to radiation therapy. Giving gossypol and temozolomide together with radiation therapy may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of gossypol when given together with temozolomide with or without radiation therapy in treating patients with newly diagnosed glioblastoma multiforme.
Condition | Intervention | Phase |
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Brain and Central Nervous System Tumors |
Drug: R-(-)-gossypol acetic acid Drug: temozolomide Genetic: gene expression analysis Genetic: mutation analysis Genetic: protein expression analysis Other: laboratory biomarker analysis Other: pharmacological study Procedure: adjuvant therapy Radiation: radiation therapy |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label |
Official Title: | A Phase I, Open Label Study of AT-101 Plus Radiotherapy and Temozolomide and of AT-101 Plus Adjuvant Temozolomide for Patients With Newly-Diagnosed Glioblastoma Multiforme |
Estimated Enrollment: | 50 |
Study Start Date: | February 2007 |
Estimated Primary Completion Date: | March 2008 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter, open-label, nonrandomized, dose-escalation study of gossypol. Patients are assigned to 1 of 2 treatment groups. Patients who participate in group I are NOT eligible for group II.
Patients undergo blood collection periodically for pharmacokinetic studies. Tumor tissue samples are examined for biomarkers including, but not limited to, Bcl-2 family protein expression (e.g., Bcl-2, Bcl-xL, MCl-1, Bax, Bak, and BH3 domain), MGMT gene methylation status, and gene expression array.
After completion of study treatment, patients are followed every 2 months.
PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Meets 1 of the following criteria:
PATIENT CHARACTERISTICS:
No gastrointestinal disease including any of the following:
PRIOR CONCURRENT THERAPY:
No prior radiotherapy, chemotherapy, immunotherapy, therapy with biologic agents (including immunotoxins, immunoconjugates, antisense agents, peptide-receptor antagonists, interferons, interleukins, tumor-infiltrating lymphocyte therapy, lymphokine-activated killer cells or gene therapy), or hormonal therapy for this brain tumor (group I)
No concurrent iron supplements
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, 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 | Lurleen Wallace Comprehensive Cancer at University of Alabama-Birmingham |
Study ID Numbers: | CDR0000507451, NABTT-0602 |
Study First Received: | October 18, 2006 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00390403 History of Changes |
Health Authority: | United States: Food and Drug Administration |
adult glioblastoma adult gliosarcoma adult giant cell glioblastoma |
Glioblastoma Astrocytoma Contraceptive Agents Contraceptive Agents, Female Adjuvants, Immunologic Central Nervous System Neoplasms Contraceptive Agents, Male Temozolomide Gossypol acetic acid Gossypol Neuroectodermal Tumors |
Neoplasms, Germ Cell and Embryonal Retinol acetate Neuroepithelioma Antineoplastic Agents, Alkylating Glioma Glioblastoma Multiforme Gliosarcoma Alkylating Agents Antineoplastic Agents, Phytogenic Nervous System Neoplasms Neoplasms, Glandular and Epithelial |
Glioblastoma Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Contraceptive 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 Alkylating Agents Nervous System Neoplasms Neoplasms by Histologic Type Astrocytoma Nervous System Diseases Gossypol acetic acid Temozolomide Pharmacologic Actions Neuroectodermal Tumors Neoplasms Antineoplastic Agents, Alkylating Neoplasms, Neuroepithelial Spermatocidal Agents Antineoplastic Agents, Phytogenic |