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Sponsors and Collaborators: |
Radiation Therapy Oncology Group National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00305864 |
RATIONALE: 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. Motexafin gadolinium may help temozolomide work better by making tumor cells more sensitive to the drug. Radiation therapy uses high-energy x-rays to kill tumor cells. Motexafin gadolinium may also make tumor cells more sensitive to radiation therapy. Giving motexafin gadolinium together with temozolomide and radition therapy may kill more tumor cells.
PURPOSE: This phase I/II trial is studying the side effects and best dose of motexafin gadolinium when given together with temozolomide and radiation therapy and to see how well they work in treating patients with newly diagnosed supratentorial glioblastoma multiforme or gliosarcoma.
Condition | Intervention | Phase |
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Brain and Central Nervous System Tumors |
Drug: motexafin gadolinium Drug: temozolomide Procedure: adjuvant therapy Radiation: radiation therapy |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | A Phase I/II Trial of Temozolomide, Motexafin Gadolinium, and 60 Gy Fractionated Radiation for Newly Diagnosed Supratentorial Glioblastoma Multiforme |
Estimated Enrollment: | 113 |
Study Start Date: | February 2006 |
Estimated Primary Completion Date: | July 2009 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: This is a multicenter, dose-escalation study of motexafin gadolinium (MGd).
Cohorts of 3-7 patients receive escalating doses of MGd until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which no more than 6 eligible patients experience dose-limiting toxicity.
PROJECTED ACCRUAL: A total of 113 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:
Histologically confirmed glioblastoma multiforme (GBM) or gliosarcoma
Supratentorial location, as determined by the following:
PATIENT CHARACTERISTICS:
No severe, active comorbidity, defined as follows:
PRIOR CONCURRENT THERAPY:
No prior systemic chemotherapy, including polifeprosan 20 with carmustine implant (Gliadel wafer), for the current GBM
Study Chair: | David G. Brachman, MD, FACRO | Arizona Oncology Services Foundation |
Investigator: | Lynn S. Ashby, MD | Barrow Neurological Institute at St. Joseph's Hospital and Medical Center |
Responsible Party: | Radiation Therapy Oncology Group ( Walter John Curran, Jr ) |
Study ID Numbers: | CDR0000467802, RTOG-0513 |
Study First Received: | March 21, 2006 |
Last Updated: | May 1, 2009 |
ClinicalTrials.gov Identifier: | NCT00305864 History of Changes |
Health Authority: | Unspecified |
adult glioblastoma adult giant cell glioblastoma adult gliosarcoma |
Glioblastoma Astrocytoma Adjuvants, Immunologic Central Nervous System Neoplasms Motexafin gadolinium Temozolomide Neuroectodermal Tumors Photosensitizing Agents Radiation-Sensitizing Agents |
Neoplasms, Germ Cell and Embryonal Neuroepithelioma Antineoplastic Agents, Alkylating Glioma Glioblastoma Multiforme Gliosarcoma Alkylating Agents Nervous System Neoplasms Neoplasms, Glandular and Epithelial |
Glioblastoma Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Neoplasms, Nerve Tissue Physiological Effects of Drugs Central Nervous System Neoplasms Neoplasms by Site Neoplasms, Germ Cell and Embryonal Therapeutic Uses Glioma Dermatologic Agents Alkylating Agents Nervous System Neoplasms |
Neoplasms by Histologic Type Astrocytoma Nervous System Diseases Motexafin gadolinium Temozolomide Pharmacologic Actions Neuroectodermal Tumors Neoplasms Photosensitizing Agents Radiation-Sensitizing Agents Antineoplastic Agents, Alkylating Neoplasms, Neuroepithelial Neoplasms, Glandular and Epithelial |