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Sponsors and Collaborators: |
University of Iowa Eisai Medical Research Inc. |
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Information provided by: | University of Iowa |
ClinicalTrials.gov Identifier: | NCT00574964 |
The purpose of this research study is to determine if combining all three treatments of Gliadel wafers, Temozolomide and Radiation therapy at the same time is safe and more effective than one treatment at a time. The study will measure the survival of subjects treated with this combination of drugs.
Condition | Intervention | Phase |
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Primary Glioblastoma Multiforme |
Other: Gliadel Wafer, Temodar and Radiotherapy |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Phase II Treatment of Adults With Newly Diagnosed Supratentorial Glioblastoma Multiforme Treated With Gliadel Wafers, Surgery and Limited Field Radiation Plus Concomitant Temozolomide Followed by Temozolomide |
Estimated Enrollment: | 50 |
Study Start Date: | October 2005 |
Estimated Study Completion Date: | October 2010 |
Arms | Assigned Interventions |
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1: Experimental |
Other: Gliadel Wafer, Temodar and Radiotherapy
Given concurrently starting 10-30 days after surgery.
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Subjects will receive surgery + Gliadel® wafer implantation + Limited Field Radiation Therapy to a dose of 61.2 Gy with concomitant daily temozolomide. Up to 8 wafers will be implanted into the tumor resection cavity (depending upon its size) after maximal tumor resection. Between days 10 and 30 all subjects will begin a standard course of post-operative limited field radiation therapy to the tumor site and a surrounding margin, with concomitant daily temozolomide (75mg/m2 x 7 d/wk for 6 weeks, concomitant chemoradiotherapy phase). Beginning no later than 45 days following completion of radiation, temozolomide will be given at a dosage of 200 mg/m2 daily for five days on a 28 day schedule, for a total of 6 cycles (adjuvant chemotherapy phase). Subjects will be monitored weekly during chemoradiotherapy with CBC with differential and brief clinical assessment, and monthly during the adjuvant chemotherapy phase. Toxicity reports will be assessed every three months. Dose limiting toxicities (DLT) are defined in section 4.2. If toxic events unresponsive to planned dose modification exceed 20% of enrolled subjects the stopping rule will be met and the study will be discontinued. MRIs will be obtained no more than 72 hours post-op, and then prior to the first, third, and fifth cycles of monthly temozolomide. Additionally, a stealth MRI or CT scan (with or without contrast) will be done one week prior to radiotherapy for treatment planning at the discretion of the treating Radiation Oncologist. Following completion of the entire course of treatment subjects will be monitored clinically as well as with MRI every 3 months for survival and evidence of progression.
Ages Eligible for Study: | 18 Years to 85 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Subjects must have normal organ and marrow function as defined below:
Exclusion Criteria:
Contact: Timothy Ryken, MD | 319-356-3853 | timothy-ryken@uiowa.edu |
Contact: Melanie Frees,, RN | 319-384-8288 | melanie-frees@uiowa.edu |
United States, Iowa | |
Holden Comprehensive Cancer Clinic | Recruiting |
Iowa City, Iowa, United States, 52242 | |
Contact: Timothy Ryken, MD 319-356-3853 timothy-ryken@uiowa.edu | |
Contact: Melanie Frees, RN 319-384-8288 melanie-frees@uiowa.edu | |
Principal Investigator: Timothy Ryken, MD |
Principal Investigator: | Timothy Ryken, MD | University of Iowa |
Responsible Party: | University of Iowa ( Timothy Ryken, MD ) |
Study ID Numbers: | 200408035 |
Study First Received: | December 14, 2007 |
Last Updated: | December 14, 2007 |
ClinicalTrials.gov Identifier: | NCT00574964 |
Health Authority: | United States: Institutional Review Board; United States: Federal Government |
Neuroectodermal Tumors Glioblastoma Glioblastoma multiforme Astrocytoma Neoplasms, Germ Cell and Embryonal |
Carmustine Neuroepithelioma Glioma Temozolomide Neoplasms, Glandular and Epithelial |
Neoplasms Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Therapeutic Uses |
Neoplasms, Nerve Tissue Antineoplastic Agents, Alkylating Neoplasms, Neuroepithelial Alkylating Agents Pharmacologic Actions |