Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsors and Collaborators: |
Dana-Farber Cancer Institute National Cancer Institute (NCI) |
---|---|
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00047294 |
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.
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
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 |
Study ID Numbers: | CDR0000257587, DFCI-00302, NCI-G02-2118, CELGENE-2000-P-002521/1 |
Study First Received: | October 3, 2002 |
Last Updated: | December 11, 2008 |
ClinicalTrials.gov Identifier: | NCT00047294 |
Health Authority: | United States: Federal Government |
adult mixed glioma adult glioblastoma adult giant cell glioblastoma adult gliosarcoma |
Glioblastoma Celecoxib Astrocytoma Thalidomide Central Nervous System Neoplasms Temozolomide Neuroectodermal Tumors |
Glioblastoma multiforme Neoplasms, Germ Cell and Embryonal Neuroepithelioma Glioma Gliosarcoma Nervous System Neoplasms Neoplasms, Glandular and Epithelial |
Anti-Inflammatory Agents Anti-Infective Agents Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Neoplasms, Nerve Tissue Anti-Bacterial Agents Neoplasms by Site Sensory System Agents Therapeutic Uses Anti-Inflammatory Agents, Non-Steroidal Analgesics Angiogenesis Modulating Agents Growth Inhibitors |
Alkylating Agents Neoplasms by Histologic Type Growth Substances Nervous System Diseases Cyclooxygenase Inhibitors Enzyme Inhibitors Immunosuppressive Agents Angiogenesis Inhibitors Pharmacologic Actions Neoplasms Analgesics, Non-Narcotic Peripheral Nervous System Agents Antineoplastic Agents, Alkylating Antirheumatic Agents Neoplasms, Neuroepithelial |