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Sponsors and Collaborators: |
North Central Cancer Treatment Group National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00316849 |
RATIONALE: Temsirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. 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. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving temsirolimus together with temozolomide and radiation therapy may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of temsirolimus when given together with temozolomide and radiation therapy in treating patients with newly diagnosed glioblastoma multiforme.
Condition | Intervention | Phase |
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Brain and Central Nervous System Tumors |
Drug: temozolomide Drug: temsirolimus Procedure: 3-dimensional conformal radiation therapy Procedure: adjuvant therapy Procedure: intensity-modulated radiation therapy Procedure: pharmacological study |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | A Phase I Study of CCI-779, and Temozolomide in Combination With Radiation Therapy in Glioblastoma Multiforme |
Estimated Enrollment: | 56 |
Study Start Date: | May 2006 |
Estimated Primary Completion Date: | April 2008 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter, dose-escalation study of temsirolimus. Patients are assigned to 1 of 2 treatment groups.
Cohorts of 3-6 patients receive escalating doses of temsirolimus until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience a dose-limiting toxicity. At least 6 patients are treated at the MTD.
Some patients undergo blood collection for immune monitoring and translational/pharmacologic studies.
After completion of study treatment, patients are followed periodically for 5 years.
PROJECTED ACCRUAL: A total of 46 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)
Newly diagnosed disease
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
No concurrent enzyme-inducing anticonvulsants, including any of the following:
Not receiving warfarin prior to study registration
United States, Arizona | |
Mayo Clinic Scottsdale | Recruiting |
Scottsdale, Arizona, United States, 85259-5499 | |
Contact: Clinical Trials Office - All Mayo Clinic Locations 507-538-7623 | |
United States, Florida | |
Mayo Clinic - Jacksonville | Recruiting |
Jacksonville, Florida, United States, 32224 | |
Contact: Clinical Trials Office - All Mayo Clinic Locations 507-538-7623 | |
United States, Minnesota | |
Mayo Clinic Cancer Center | Recruiting |
Rochester, Minnesota, United States, 55905 | |
Contact: Clinical Trials Office - All Mayo Clinic Locations 507-538-7623 |
Study Chair: | Jann N. Sarkaria, MD | Mayo Clinic |
Investigator: | Evanthia Galanis, MD | Mayo Clinic |
Investigator: | John Fiveash, MD | Lurleen Wallace Comprehensive Cancer at University of Alabama-Birmingham |
Investigator: | Jan C. Buckner, MD | Mayo Clinic |
Investigator: | Paul D. Brown, MD | Mayo Clinic |
Investigator: | Joon H. Uhm, MD | Mayo Clinic |
Investigator: | Kurt A. Jaeckle, MD | Mayo Clinic |
Investigator: | Bradley J. Erickson, MD, PhD | Mayo Clinic |
Study ID Numbers: | CDR0000467232, NCCTG-N027D |
Study First Received: | April 19, 2006 |
Last Updated: | September 17, 2008 |
ClinicalTrials.gov Identifier: | NCT00316849 |
Health Authority: | Unspecified |
adult glioblastoma adult giant cell glioblastoma adult gliosarcoma |
Neuroectodermal Tumors Glioblastoma Glioblastoma multiforme Astrocytoma Neoplasms, Germ Cell and Embryonal Neuroepithelioma |
Glioma Central Nervous System Neoplasms Gliosarcoma Temozolomide Nervous System Neoplasms Neoplasms, Glandular and Epithelial |
Neoplasms Neoplasms by Site Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Therapeutic Uses |
Nervous System Diseases Neoplasms, Nerve Tissue Antineoplastic Agents, Alkylating Neoplasms, Neuroepithelial Alkylating Agents Pharmacologic Actions |