This trial is active, not recruiting.

Condition brain and central nervous system tumors
Treatments celecoxib, temozolomide, thalidomide, adjuvant therapy
Phase phase 2
Sponsor Dana-Farber Cancer Institute
Collaborator National Cancer Institute (NCI)
Start date April 2002
Trial identifier NCT00047294, CDR0000257587, CELGENE-2000-P-002521/1, DFCI-00302, NCI-G02-2118


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Masking open label
Primary purpose treatment

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Phase II Study Of Temozolomide, Thalidomide And Celecoxib In Patients With Newly Diagnosed Glioblastoma Multiforme In The Post-Radiation Setting
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in February 2009.
Information provided to ClinicalTrials.gov by National Cancer Institute (NCI).