Thalidomide, Celecoxib, and Combination Chemotherapy in Treating Patients With Relapsed or Refractory Malignant Glioma
Recruitment status was Active, not recruiting
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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 2 |
| Study Type: | Interventional |
| Study Design: | Masking: Open Label Primary Purpose: Treatment |
| 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:
- Determine the efficacy of thalidomide, celecoxib, etoposide, and cyclophosphamide, in terms of 6-month progression-free survival, in patients with relapsed or refractory malignant glioma.
- Determine the overall survival of patients treated with this regimen.
- Determine the toxic effects of this regimen in these patients.
- Determine the radiographic response in patients treated with this regimen.
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:
- Histologically confirmed intracranial malignant glioma, including glioblastoma multiforme, gliosarcoma, anaplastic astrocytoma, anaplastic oligodendroglioma, anaplastic mixed oligoastrocytoma, or malignant astrocytoma not otherwise specified
Unequivocal evidence of relapsed or refractory disease by MRI or CT scan and/or tumor resection
- Steroid therapy prior to MRI or CT scan must have been at a stable dose for at least 5 days
Failed prior radiotherapy
- Must have confirmation of true progression rather than radiation necrosis if previously treated with interstitial brachytherapy or stereotactic radiosurgery
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- Karnofsky 60-100%
Life expectancy
- More than 2 months
Hematopoietic
- Absolute neutrophil count at least 1,500/mm3
- Platelet count at least 100,000/mm3
- Hemoglobin greater than 9 g/dL
- No history of bleeding disorder
Hepatic
- Bilirubin less than 1.5 mg/dL
- SGPT less than 2.5 times normal
- Alkaline phosphatase less than 2.5 times normal
Renal
- Creatinine less than 1.5 times upper limit of normal (ULN) OR
- BUN less than 1.5 times ULN
Cardiovascular
- No deep vein thrombosis within the past 3 weeks (must be clinically stable)
Pulmonary
- No pulmonary embolism within the past 3 weeks (must be clinically stable)
Other
- No peripheral neuropathy grade 2 or greater
- No active infection
- No other serious concurrent medical illness
- No concurrent illness that may obscure toxicity or dangerously alter drug metabolism
- No other malignancy within the past 3 years except nonmelanoma skin cancer or carcinoma in situ of the cervix
- Must participate in the System for Thalidomide Education and Prescribing Safety program
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use 2 forms of effective contraception for 1 month before, during, and for 1 month after study
PRIOR CONCURRENT THERAPY:
Biologic therapy
- No prior oral thalidomide or celecoxib for more than 2 months duration
Chemotherapy
- No prior oral etoposide or cyclophosphamide for more than 2 months duration
- Prior standard-dose IV etoposide and cyclophosphamide allowed
Endocrine therapy
- See Disease Characteristics
- Concurrent steroids allowed
Radiotherapy
- See Disease Characteristics
- At least 4 weeks since prior radiotherapy
Surgery
- See Disease Characteristics
- Prior surgery for relapsed or refractory disease allowed
- Recovered from prior surgery
- No concurrent surgery
Other
- No other concurrent investigational agents or treatment
- No other concurrent anticancer therapy
- Concurrent antiseizure medications allowed
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
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00047281 History of Changes |
| Other 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 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
adult anaplastic astrocytoma adult anaplastic oligodendroglioma adult glioblastoma adult mixed glioma |
recurrent adult brain tumor adult giant cell glioblastoma adult gliosarcoma |
Additional relevant MeSH terms:
|
Glioma Nervous System Neoplasms Central Nervous System Neoplasms Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms by Site Nervous System Diseases Cyclophosphamide Thalidomide Etoposide phosphate |
Etoposide Celecoxib Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antirheumatic Agents Therapeutic Uses Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Myeloablative Agonists Antineoplastic Agents, Phytogenic Leprostatic Agents |
ClinicalTrials.gov processed this record on May 22, 2013