Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

Temozolomide, Thalidomide, and Celecoxib Following Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Closed	18 and over	NCI, Pharmaceutical / Industry	DFCI-00302 NCI-G02-2118, CELGENE-2000-P-002521/1, NCT00047294

Objectives

1. 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.
2. Determine the toxicity of this regimen in these patients.

Entry 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

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

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

Expected Enrollment

A total of 55 patients will be accrued for this study.

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.

Kesari S, Schiff D, Henson JW, et al.: Phase II study of temozolomide, thalidomide, and celecoxib for newly diagnosed glioblastoma in adults. Neuro Oncol 10 (3): 300-8, 2008.[PUBMED Abstract]

Wen PY, Gigas DC, MacDonald L, et al.: Phase II study of temozolomide, thalidomide, and celecoxib for newly diagnosed glioblastoma. [Abstract] Neuro-Oncology 6 (4): TA-64, 385, 2004.

Trial Contact Information

Trial Lead Organizations

Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute

Patrick Wen, MD, Protocol chair		Ph: 617-632-2166; 866-790-4500 Email: patrick_wen@dfci.harvard.edu

Registry Information
Official Title		Phase II Study Of Temozolomide, Thalidomide And Celecoxib In Patients With Newly Diagnosed Glioblastoma Multiforme In The Post-Radiation Setting
Trial Start Date		2002-04-17
Registered in ClinicalTrials.gov		NCT00047294
Date Submitted to PDQ		2002-08-26
Information Last Verified		2005-05-25
NCI Grant/Contract Number		P30-CA06516

Back to Top