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.

Condition	Treatment or Intervention	Phase
Mixed Gliomas adult glioblastoma adult giant cell glioblastoma adult gliosarcoma	Drug: celecoxib  Drug: temozolomide  Drug: thalidomide  Procedure: adjuvant therapy  Procedure: anti-cytokine therapy  Procedure: antiangiogenesis therapy  Procedure: biological response modifier therapy  Procedure: chemosensitization/potentiation  Procedure: chemotherapy  Procedure: enzyme inhibitor therapy  Procedure: growth factor antagonist therapy	Phase II

Further Study Details: 

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.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

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

Massachusetts
      Brigham and Women's Hospital, Boston,  Massachusetts,  02115,  United States
      Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute, Boston,  Massachusetts,  02115,  United States
      Massachusetts General Hospital Cancer Center, Boston,  Massachusetts,  02114,  United States
Virginia
      Cancer Center at the University of Virginia, Charlottesville,  Virginia,  22908,  United States

Study chairs or principal investigators

Patrick Y. Wen, MD,  Study Chair,  Dana-Farber/Harvard Cancer Center   

Study ID Numbers:  CDR0000257587; DFCI-00302; NCI-G02-2118; CELGENE-2000-P-002521/1; NCT00047294
Record last reviewed:  January 2005
Last Updated:  January 6, 2005
Record first received:  October 3, 2002
ClinicalTrials.gov Identifier:  NCT00047294
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08