Phase II Study Of Temozolomide, Thalidomide And Celecoxib In Patients With Newly Diagnosed Glioblastoma Multiforme In The Post-Radiation Setting
18 Years
N/A
Both
Brain and Central Nervous System Tumors
Trial Information
Phase II Study Of Temozolomide, Thalidomide And Celecoxib In Patients With Newly Diagnosed Glioblastoma Multiforme In The Post-Radiation Setting
OBJECTIVES:
- Determine the efficacy of adjuvant temozolomide, thalidomide, and celecoxib after
radiotherapy, in terms of time to tumor progression and overall survival, in patients
with newly diagnosed glioblastoma multiforme.
- Determine the toxicity of this regimen in these patients.
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.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed supratentorial glioblastoma multiforme or gliosarcoma
- Completed standard external beam radiotherapy within the past 5 weeks
- Stable disease by MRI or CT scan
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- Karnofsky 60-100%
Life expectancy
- More than 4 months
Hematopoietic
- Absolute neutrophil count at least 1,500/mm3
- Platelet count at least 100,000/mm3
- 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
- BUN less than 1.5 times upper limit of normal (ULN) OR
- Creatinine 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
- Must participate in System for Thalidomide Education and Prescribing Safety program
- No peripheral neuropathy grade 2 or greater
- No active infection
- No concurrent illness that may obscure toxicity or dangerously alter drug metabolism
- No other serious concurrent illness
- No other malignancy within the past 3 years except nonmelanoma skin cancer or
carcinoma in situ of the cervix
- 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 thalidomide
- No concurrent immunotherapy
- No concurrent prophylactic filgrastim (G-CSF)
Chemotherapy
- No prior chemotherapy
- No other concurrent chemotherapy
Endocrine therapy
- No concurrent hormonal therapy
- Concurrent corticosteroids must be at stable or decreasing dose over the past 7 days
Radiotherapy
- See Disease Characteristics
- No concurrent radiotherapy
Surgery
- No concurrent surgery
Other
- No other concurrent anticancer therapy
- No other concurrent investigational agents
Type of Study:
Interventional
Study Design:
Masking: Open Label, Primary Purpose: Treatment
Principal Investigator
Patrick Y. Wen, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Dana-Farber Cancer Institute
Authority:
United States: Federal Government
Study ID:
CDR0000257587
NCT ID:
NCT00047294
Start Date:
April 2002
Completion Date:
Related Keywords:
- Brain and Central Nervous System Tumors
- adult mixed glioma
- adult glioblastoma
- adult giant cell glioblastoma
- adult gliosarcoma
- Glioblastoma
- Nervous System Neoplasms
- Central Nervous System Neoplasms
Name | Location |
|---|---|
| Massachusetts General Hospital Cancer Center | Boston, Massachusetts 02114 |
| Cancer Center at the University of Virginia | Charlottesville, Virginia 22908 |
| Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute | Boston, Massachusetts 02115 |
| Brigham and Women's Hospital | Boston, Massachusetts 02115 |
