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Sponsored by: |
National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00486603 |
RATIONALE: Drugs used in chemotherapy, such as hydroxychloroquine 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. Giving hydroxychloroquine 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 hydroxychloroquine when given together with radiation therapy and temozolomide and to see how well they work in treating patients with newly diagnosed glioblastoma multiforme.
Condition | Intervention | Phase |
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Brain and Central Nervous System Tumors |
Drug: hydroxychloroquine Drug: temozolomide Procedure: 3-dimensional conformal radiation therapy Procedure: adjuvant therapy Procedure: immunologic technique Procedure: intensity-modulated radiation therapy Procedure: laboratory biomarker analysis Procedure: mutation analysis Procedure: pharmacological study Procedure: polymerase chain reaction |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase I/II Trial of Hydroxychloroquine in Conjunction With Radiation Therapy and Concurrent and Adjuvant Temozolomide in Patients With Newly Diagnosed Glioblastoma Multiforme |
Estimated Enrollment: | 94 |
Study Start Date: | October 2007 |
Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter, open-label, phase I, dose-escalation study of hydroxychloroquine followed by a phase II study.
Phase I:
Cohorts of 3-6 patients receive escalating doses of hydroxychloroquine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
Maintenance therapy: Beginning 28 days after completion of radiotherapy, patients receive oral temozolomide on days 1-5 and oral hydroxychloroquine on days 1-28. Treatment repeats every 4 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients may then continue to receive hydroxychloroquine alone as above in the absence of disease progression or unacceptable toxicity.
Patients undergo blood and tissue sample collection periodically for pharmacological and correlative studies. Samples are analyzed for the mutational status of TP53 and PTEN genes and copy number of BECN1 via PCR; changes in autophagy protein LC3 via gel electrophoresis; and differences in the formation of LC3-II via immunoblotting.
After completion of study treatment, 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 grade IV supratentorial astrocytoma (glioblastoma multiforme)
Newly diagnosed disease
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
United States, Alabama | |
Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham | Recruiting |
Birmingham, Alabama, United States, 35294 | |
Contact: Clinical Trials Office - Lurleen Wallace Comprehensive Cancer 205-934-0309 | |
United States, Florida | |
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 | |
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, North Carolina | |
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 | |
Case Comprehensive Cancer Center | Recruiting |
Cleveland, Ohio, United States, 44106-5065 | |
Contact: Clinical Trials Office - Case Comprehensive Cancer Center 800-641-2422 | |
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 |
Study Chair: | Myrna Rosenfeld, MD, PhD | University of Pennsylvania |
Study ID Numbers: | CDR0000549734, NABTT-0603 |
Study First Received: | June 13, 2007 |
Last Updated: | December 2, 2008 |
ClinicalTrials.gov Identifier: | NCT00486603 |
Health Authority: | Unspecified |
adult glioblastoma adult gliosarcoma adult giant cell glioblastoma |
Glioblastoma Astrocytoma Central Nervous System Neoplasms Temozolomide Neuroectodermal Tumors Glioblastoma multiforme Neoplasms, Germ Cell and Embryonal |
Hydroxychloroquine Neuroepithelioma Glioma Gliosarcoma Nervous System Neoplasms Neoplasms, Glandular and Epithelial |
Anti-Infective Agents Antiprotozoal Agents Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Neoplasms, Nerve Tissue Nervous System Diseases Enzyme Inhibitors Pharmacologic Actions |
Antimalarials Antiparasitic Agents Neoplasms Neoplasms by Site Therapeutic Uses Antineoplastic Agents, Alkylating Neoplasms, Neuroepithelial Antirheumatic Agents Alkylating Agents |