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| Sponsor: | Dana-Farber Cancer Institute |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00047281 |
Purpose
RATIONALE: Thalidomide and celecoxib may stop the growth of tumor cells by stopping blood flow to the tumor. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining thalidomide and celecoxib with etoposide and cyclophosphamide may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combining thalidomide and celecoxib with etoposide and cyclophosphamide in treating patients who have relapsed or refractory malignant glioma.
| Condition | Intervention | Phase |
|---|---|---|
|
Brain and Central Nervous System Tumors |
Drug: celecoxib Drug: cyclophosphamide Drug: etoposide Drug: thalidomide |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label |
| Official Title: | Trial Of Oral Thalidomide, Celecoxib, Etoposide And Cyclophosphamide In Adult Patients With Relapsed Or Progressive Malignant Gliomas |
| Study Start Date: | March 2002 |
OBJECTIVES:
OUTLINE: This is a multicenter study.
Patients receive oral thalidomide once daily and oral celecoxib twice daily on days 1-42, oral etoposide once daily on days 1-21, and oral cyclophosphamide once daily on days 22-42. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.
Patients are followed every 2 months.
PROJECTED ACCRUAL: A total of 48 patients (32 with glioblastoma multiforme and 16 with anaplastic glioma) will be accrued for this study within 2 years.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Unequivocal evidence of relapsed or refractory disease by MRI or CT scan and/or tumor resection
Failed prior radiotherapy
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 | |
| Study Chair: | Patrick Y. Wen, MD | Dana-Farber Cancer Institute |
More Information
| Study ID Numbers: | CDR0000257584, DFCI-01278, NCI-G02-2117, CELGENE-2001-P-001757/3 |
| Study First Received: | October 3, 2002 |
| Last Updated: | November 22, 2008 |
| ClinicalTrials.gov Identifier: | NCT00047281 History of Changes |
| Health Authority: | United States: Federal Government |
|
adult anaplastic astrocytoma adult anaplastic oligodendroglioma adult glioblastoma adult mixed glioma |
recurrent adult brain tumor adult giant cell glioblastoma adult gliosarcoma |
|
Anti-Inflammatory Agents Anti-Infective Agents Molecular Mechanisms of Pharmacological Action Thalidomide Immunologic Factors Antineoplastic Agents Neoplasms, Nerve Tissue Physiological Effects of Drugs Cyclophosphamide Central Nervous System Neoplasms Etoposide phosphate 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 Etoposide Alkylating Agents Nervous System Neoplasms Neoplasms by Histologic Type Celecoxib Growth Substances Cyclooxygenase Inhibitors Nervous System Diseases Enzyme Inhibitors |