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Sponsors and Collaborators: |
Beckman Research Institute National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00720564 |
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as arsenic trioxide and temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Arsenic trioxide and temozolomide may also make tumor cells more sensitive to radiation therapy. Giving radiation therapy together with combination chemotherapy may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of arsenic trioxide when given together with temozolomide and radiation therapy in treating patients with newly diagnosed high-grade glioma.
Condition | Intervention | Phase |
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Brain and Central Nervous System Tumors |
Drug: arsenic trioxide Drug: temozolomide Procedure: adjuvant therapy Radiation: intensity-modulated radiation therapy Radiation: radiation therapy |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | A Phase I Study of the Combination of Radiation Therapy (RT), Arsenic Trioxide (ATO) and Temozolomide (TMZ) in Patients With Newly-Diagnosed Glioblastoma Multiforme (GBM) |
Estimated Enrollment: | 18 |
Study Start Date: | April 2008 |
Estimated Primary Completion Date: | April 2010 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: This is a dose-escalation study of arsenic trioxide.
Patients undergo radiotherapy (may be intensity-modulated) on days 1-5. Patients also receive arsenic trioxide IV over 1-2 hours on days 1-5, and oral temozolomide on days 1-7. Treatment with radiotherapy, arsenic trioxide, and temozolomide repeats every week for up to 6 weeks in the absence of disease progression or unacceptable toxicity.
Patients may then receive oral temozolomide on days 1-5. Treatment repeats every 4 weeks for up to 12 courses in the absence of disease progression.
After completion of study therapy, patients are followed periodically.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Newly diagnosed grade III or IV glioma including any of the following:
No more than 5 weeks since prior brain surgery
Preoperatively and postoperatively diagnostic contrast-enhanced MRI or CT scan of the brain performed prior to radiation therapy
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
United States, California | |
City of Hope Comprehensive Cancer Center | Recruiting |
Duarte, California, United States, 91010-3000 | |
Contact: Jana Portnow, MD 800-826-4673 JPortnow@coh.org |
Principal Investigator: | Jana Portnow, MD | Beckman Research Institute |
Responsible Party: | City of Hope Comprehensive Cancer Center ( Jana Portnow ) |
Study ID Numbers: | CDR0000600335, CHNMC-07058, CEPHALON-CHNMC-07058 |
Study First Received: | July 19, 2008 |
Last Updated: | June 23, 2009 |
ClinicalTrials.gov Identifier: | NCT00720564 History of Changes |
Health Authority: | Unspecified |
adult glioblastoma adult anaplastic astrocytoma adult anaplastic oligodendroglioma adult gliosarcoma adult mixed glioma |
Glioblastoma Astrocytoma Adjuvants, Immunologic Arsenic trioxide Central Nervous System Neoplasms Temozolomide Oligodendroglioma |
Glioma Glioblastoma Multiforme Antineoplastic Agents, Alkylating Gliosarcoma Alkylating Agents Nervous System Neoplasms |
Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Nervous System Diseases Arsenic trioxide Central Nervous System Neoplasms Temozolomide Pharmacologic Actions |
Neoplasms Neoplasms by Site Therapeutic Uses Antineoplastic Agents, Alkylating Alkylating Agents Nervous System Neoplasms |