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| Sponsors and Collaborators: |
Dana-Farber Cancer Institute National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00047294 |
Purpose
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Thalidomide and celecoxib may stop the growth of tumor cells by stopping blood flow to the tumor and may increase the effectiveness of temozolomide by making tumor cells more sensitive to the drug.
PURPOSE: Phase II trial to study the effectiveness of combining temozolomide, thalidomide, and celecoxib following radiation therapy in treating patients who have newly diagnosed glioblastoma multiforme.
| Condition | Intervention | Phase |
|---|---|---|
|
Brain and Central Nervous System Tumors |
Drug: celecoxib Drug: temozolomide Drug: thalidomide Procedure: adjuvant therapy |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label |
| Official Title: | Phase II Study Of Temozolomide, Thalidomide And Celecoxib In Patients With Newly Diagnosed Glioblastoma Multiforme In The Post-Radiation Setting |
| Study Start Date: | April 2002 |
OBJECTIVES:
OUTLINE: This is a multicenter study.
Patients receive oral temozolomide once daily on days 1-5 and oral thalidomide once daily and oral celecoxib twice daily on days 1-28. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed for survival.
PROJECTED ACCRUAL: A total of 55 patients will be accrued for this study.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Pulmonary
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Contacts and Locations| United States, Massachusetts | |
| Brigham and Women's Hospital | |
| Boston, Massachusetts, United States, 02115 | |
| Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute | |
| Boston, Massachusetts, United States, 02115 | |
| Massachusetts General Hospital Cancer Center | |
| Boston, Massachusetts, United States, 02114 | |
| United States, Virginia | |
| Cancer Center at the University of Virginia | |
| Charlottesville, Virginia, United States, 22908 | |
| Study Chair: | Patrick Y. Wen, MD | Dana-Farber Cancer Institute |
More Information
| Study ID Numbers: | CDR0000257587, DFCI-00302, NCI-G02-2118, CELGENE-2000-P-002521/1 |
| Study First Received: | October 3, 2002 |
| Last Updated: | February 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00047294 History of Changes |
| Health Authority: | United States: Federal Government |
|
adult mixed glioma adult glioblastoma adult giant cell glioblastoma adult gliosarcoma |
|
Anti-Inflammatory Agents Glioblastoma Thalidomide Immunologic Factors Central Nervous System Neoplasms Anti-Bacterial Agents Neoplasms, Germ Cell and Embryonal Neuroepithelioma Anti-Inflammatory Agents, Non-Steroidal Glioblastoma Multiforme Glioma Analgesics Alkylating Agents Nervous System Neoplasms |
Celecoxib Astrocytoma Cyclooxygenase Inhibitors Adjuvants, Immunologic Temozolomide Immunosuppressive Agents Angiogenesis Inhibitors Neuroectodermal Tumors Analgesics, Non-Narcotic Peripheral Nervous System Agents Antineoplastic Agents, Alkylating Antirheumatic Agents Gliosarcoma Neoplasms, Glandular and Epithelial |
|
Anti-Inflammatory Agents Glioblastoma Anti-Infective Agents Molecular Mechanisms of Pharmacological Action Thalidomide Immunologic Factors Antineoplastic Agents Neoplasms, Nerve Tissue Physiological Effects of Drugs Central Nervous System Neoplasms Anti-Bacterial Agents Neoplasms by Site Sensory System Agents Neoplasms, Germ Cell and Embryonal Therapeutic Uses |
Anti-Inflammatory Agents, Non-Steroidal Analgesics Growth Inhibitors Angiogenesis Modulating Agents Glioma Alkylating Agents Nervous System Neoplasms Neoplasms by Histologic Type Celecoxib Astrocytoma Growth Substances Cyclooxygenase Inhibitors Nervous System Diseases Enzyme Inhibitors Angiogenesis Inhibitors |