Status:
COMPLETED
Temozolomide Alone or in Combination With Thalidomide and/or Isotretinoin and/or Celecoxib in Treating Patients Who Have Undergone Radiation Therapy for Glioblastoma Multiforme
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Brain and Central Nervous System Tumors
Glioblastoma Multiforme
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
RATIONALE: 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. Thalidomide may st...
Detailed Description
OBJECTIVES: * Compare the efficacy of adjuvant temozolomide (TMZ) alone or in combination with thalidomide and/or isotretinoin and/or celecoxib, in terms of 6-month progression-free survival, in pati...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed supratentorial glioblastoma multiforme
- Must have undergone a biopsy OR subtotal or gross total resection of the tumor
- Must have completed post-operative (or post-biopsy) radiotherapy within the past 5 weeks
- No progressive disease after radiotherapy
- PATIENT CHARACTERISTICS:
- Age
- 18 and over
- Performance status
- Karnofsky 60-100%
- Life expectancy
- Not specified
- Hematopoietic
- Absolute neutrophil count ≥ 1,500/mm\^3
- Platelet count ≥ 100,000/mm\^3
- Hepatic
- Serum glutamate pyruvate transaminase (SGPT) \< 2 times upper limit of normal (ULN)
- Alkaline phosphatase \< 2 times ULN
- Bilirubin ≤ 1.5 mg/dL
- Renal
- blood urea nitrogen (BUN) ≤ 1.5 times ULN
- Creatinine ≤ 1.5 times ULN
- Immunologic
- No history of allergic reactions attributed to compounds of similar chemical or biological composition to celecoxib or to sulfonamides
- No asthma, urticaria, or allergic reactions to aspirin or other NSAIDs
- No active infection
- Gastrointestinal
- No inflammatory bowel disease
- No history of peptic ulcer disease
- No gastrointestinal bleeding within past 3 months
- Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective double-method contraception during and for 2 months after study participation
- Fertile female patients randomized to receive thalidomide must use effective double-method contraception for ≥ 4 weeks before, during, and ≥ 4 weeks after completion of study therapy
- Fertile male patients randomized to receive thalidomide must use effective contraception during and for ≥ 4 weeks after completion of study therapy
- No blood donation (for patients randomized to receive thalidomide)
- No history of any other cancer except nonmelanoma skin cancer or carcinoma in situ of the cervix or cancer that is in complete remission and patient completed all therapy for that disease ≥ 3 years ago
- No other disease that would obscure toxicity or dangerously alter drug metabolism (e.g., severe connective tissue disease)
- No other serious medical illness
- PRIOR CONCURRENT THERAPY:
- Biologic therapy
- Not specified
- Chemotherapy
- Prior temozolomide in combination with radiotherapy allowed
- No other prior or concurrent chemotherapy
- Endocrine therapy
- Not specified
- Radiotherapy
- See Disease Characteristics
- See Chemotherapy
- Surgery
- See Disease Characteristics
- No concurrent surgery
- Other
- No other concurrent non-steroidal anti-inflammatory drugs (NSAIDs) (for patients randomized to receive celecoxib)
- No other concurrent investigational drugs
- No other concurrent anticancer therapy
Exclusion
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2014
Estimated Enrollment :
178 Patients enrolled
Trial Details
Trial ID
NCT00112502
Start Date
September 1 2005
End Date
September 1 2014
Last Update
October 18 2021
Active Locations (12)
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1
Hembree Mercy Cancer Center at St. Edward Mercy Medical Center
Fort Smith, Arkansas, United States, 72913
2
University of Texas MD Anderson Cancer Center at Orlando
Orlando, Florida, United States, 32806-2134
3
CCOP - Atlanta Regional
Atlanta, Georgia, United States, 30342-1701
4
CCOP - Central Illinois
Decatur, Illinois, United States, 62526