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Sponsored by: |
M.D. Anderson Cancer Center |
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Information provided by: | M.D. Anderson Cancer Center |
ClinicalTrials.gov Identifier: | NCT00038493 |
This study will combine the chemotherapy agent temozolomide with the investigational drug SCH66336 (an agent which interferes with new cell growth). Patients will be treated with oral temozolomide on days 1-5 and oral SCH66336 on days 8-28 every 28 days.
Condition | Intervention | Phase |
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Glioblastoma Multiforme |
Drug: Temozolomide and SCH66336 |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study |
Official Title: | Phase II Evaluation Temozolomide and Farnesyl Transferase Inhibitor (SCH66336) for the Treatment of Recurrent and Progressive Glioblastoma Multiforme |
Estimated Enrollment: | 44 |
Study Start Date: | September 2001 |
Temozolomide at a dose of, 150-200 mg/m2, will be administered orally, after fasting for one hour, once a day for 5 consecutive days (days 1 through 5) every 4 weeks (plus up to 3 days). The starting dose level of 200 mg/m2 will be used for patients who have not previously received any chemotherapy or at 150 mg/m2 for patients who have received previous chemotherapy.
SCH66336 will be given orally, with water, in the morning and in the evening for three weeks (Days 8 - 28) every 28 days (plus up to 3 days) 1 hour before or after morning and evening meals. Patients will take 150 mg in the morning and 150 mg in the evening.
Treatment courses may be repeated every 28 days following the first daily dose of Temozolomide for the previous course.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion:
If the steroid dose is increased between the date of imaging and registration a new baseline MR/CT is required.
The same type of scan, i.e., MRI or CT must be used throughout the period of protocol treatment for tumor measurement.
Patients having undergone recent resection of recurrent or progressive tumor will be eligible as long as all of the following conditions apply:
If the 96-hour scan is more than 14 days before registration, the scan needs to be repeated. If the steroid dose is increased between the date of imaging and registration, a new baseline MRI/CT is required on a stable steroid dosage for at least 5 days.
Patients must not have:
Exclusion:
Patients with the following are ineligible:
Study ID Numbers: | DM01-258 |
Study First Received: | May 31, 2002 |
Last Updated: | August 11, 2005 |
ClinicalTrials.gov Identifier: | NCT00038493 History of Changes |
Health Authority: | United States: Food and Drug Administration |
GBM Glioma Brain Tumor |
Glioblastoma Astrocytoma Temozolomide Recurrence Brain Neoplasms Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal |
Neuroepithelioma Glioma Glioblastoma Multiforme Antineoplastic Agents, Alkylating Alkylating Agents Neoplasms, Glandular and Epithelial |
Glioblastoma Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Astrocytoma Antineoplastic Agents Neoplasms, Nerve Tissue Temozolomide Pharmacologic Actions Neuroectodermal Tumors |
Neoplasms Therapeutic Uses Neoplasms, Germ Cell and Embryonal Glioma Antineoplastic Agents, Alkylating Neoplasms, Neuroepithelial Alkylating Agents Neoplasms, Glandular and Epithelial |