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Sponsors and Collaborators: |
H. Lee Moffitt Cancer Center and Research Institute Schering-Plough |
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Information provided by: | H. Lee Moffitt Cancer Center and Research Institute |
ClinicalTrials.gov Identifier: | NCT00365222 |
A single arm Phase 2 trial with the study drug temozolomide (temodar) for newly diagnosed glioblastoma in elderly patients (defined as greater than or equal to 70 years old). Following surgical resection, and confirmation of glioblastoma, patients will proceed to primary chemotherapy with temozolomide (temodar). Temodar is given for 42 consecutive days on and 14 days off occurring every 56 days.
Procedures prior to initial study treatment (<14 Days) are: Neurological/Oncological History, Neurological Examination, Height, Weight, and Body Surface Area, Performance Status, Quality Of Life FACT-BR, Labs, MGMT tissue analysis, and Cranial CT/MRI with and without contrast.
The same procedures are repeated on Day 1 of each treatment cycle with the addition of an adverse event assessment. And the off study procedures for patients are performance status, Quality Of Life FACT-BR, MGMT tissue analysis, and cranial CT/MRI with and without contrast.
Patients may continue with each temodar daily dose therapy if clinical and neuroradiographical exams are stable or improving.
Condition | Intervention | Phase |
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Glioblastoma Gliosarcoma |
Drug: Temozolomide (Temodar) |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Phase II Study of Dose Intensive Temozolomide in Elderly Adults With Newly Diagnosed Glioblastoma |
Estimated Enrollment: | 79 |
Study Start Date: | July 2006 |
A single arm Phase 2 trial with the study drug temozolomide (temodar) for newly diagnosed glioblastoma in elderly patients (defined as greater than or equal to 70 years old). Temozolomide will be administered orally (a capsule) at approximately the same time daily (bedtime) for 42 days on and then 14 days off; cycles may be repeated every 56 days. Complete blood counts will be obtained bi-weekly, evaluations monthly and MRI’s every 2 months after a cycle of therapy.
Procedures prior to initial study treatment (<14 Days) are: Neurological/Oncological History, Neurological Examination, Height, Weight, and Body Surface Area, Performance Status, Quality Of Life FACT-BR, Labs, MGMT tissue analysis, and Cranial CT/MRI with and without contrast (all disease found at staging must be followed using the same modality used at Pre-treatment. Tumor assessments are to be repeated every 56 days thereafter until progression). The same procedures are repeated on Day 1 of each treatment cycle with the addition of an adverse event assessment.
Patients may continue on therapy unless one of the following occurs:
Patients with CR, PR, or stable disease (SD) will be treated for a minimum of 3 cycles [6 months] or until disease progression. For patients responding to treatment, continuation of therapy beyond 3 cycles is at the discretion of the investigator. Response parameters will include the MacDonald criteria for evaluating brain tumors. Response is measured by a reduction in tumor size.
After cessation of protocol therapy, patients will continue to be followed for survival at 2-month intervals for up to three years from start of treatment. And the off study procedures for patients are performance status, Quality Of Life FACT-BR, MGMT tissue analysis, and cranial CT/MRI with and without contrast.
Ages Eligible for Study: | 70 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Shirley A Entis, RN | 813-745-3929 | shirley.entis@moffitt.org |
United States, Florida | |
H. Lee Moffitt Cancer Center & Research Institute | Recruiting |
Tampa, Florida, United States, 33612 | |
Sub-Investigator: Sajeel Chowdhary, MD | |
Sub-Investigator: Clifford Schold, MD | |
Sub-Investigator: Steven Brem, MD | |
Sub-Investigator: Frank Vironis, MD | |
Sub-Investigator: Amyn Rojiani, MD, PHD | |
Sub-Investigator: Harvey Greenberg, MD |
Principal Investigator: | Marc Chamberlain, MD | H. Lee Moffitt Cancer Center and Research Institute |
Study ID Numbers: | MCC-14714 |
Study First Received: | August 15, 2006 |
Last Updated: | April 3, 2007 |
ClinicalTrials.gov Identifier: | NCT00365222 |
Health Authority: | United States: Food and Drug Administration |
Temozolomide Temodar Glioblastoma Gliosarcoma |
Brain Tumor Quality of Life Neurological |
Neuroectodermal Tumors Brain Neoplasms Glioblastoma Astrocytoma Neoplasms, Germ Cell and Embryonal Neuroepithelioma |
Quality of Life Glioma Gliosarcoma 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 |