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

Alternate Title

Thalidomide, Celecoxib, and Combination Chemotherapy in Treating Patients With Relapsed or Refractory Malignant Glioma

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Closed	18 and over	NCI, Pharmaceutical / Industry	DFCI-01278 NCI-G02-2117, CELGENE-2001-P-001757/3, NCT00047281

Objectives

1. Determine the efficacy of thalidomide, celecoxib, etoposide, and cyclophosphamide, in terms of 6-month progression-free survival, in patients with relapsed or refractory malignant glioma.
2. Determine the overall survival of patients treated with this regimen.
3. Determine the toxic effects of this regimen in these patients.
4. Determine the radiographic response in patients treated with this regimen.

Entry Criteria

Disease Characteristics:

• Histologically confirmed intracranial malignant glioma, including glioblastoma multiforme, gliosarcoma, anaplastic astrocytoma, anaplastic oligodendroglioma, anaplastic mixed oligoastrocytoma, or malignant astrocytoma not otherwise specified



• Unequivocal evidence of relapsed or refractory disease by MRI or CT scan and/or tumor resection
  • Steroid therapy prior to MRI or CT scan must have been at a stable dose for at least 5 days
  • Failed prior radiotherapy
    • Must have confirmation of true progression rather than radiation necrosis if previously treated with interstitial brachytherapy or stereotactic radiosurgery

Prior/Concurrent Therapy:

Biologic therapy

• No prior oral thalidomide or celecoxib for more than 2 months duration

Chemotherapy

• No prior oral etoposide or cyclophosphamide for more than 2 months duration
• Prior standard-dose IV etoposide and cyclophosphamide allowed

Endocrine therapy

• See Disease Characteristics
• Concurrent steroids allowed

Radiotherapy

• See Disease Characteristics
• At least 4 weeks since prior radiotherapy

Surgery

• See Disease Characteristics
• Prior surgery for relapsed or refractory disease allowed
• Recovered from prior surgery
• No concurrent surgery

Other

• No other concurrent investigational agents or treatment
• No other concurrent anticancer therapy
• Concurrent antiseizure medications allowed

Patient Characteristics:

Age

• 18 and over

Performance status

• Karnofsky 60-100%

Life expectancy

• More than 2 months

Hematopoietic

• Absolute neutrophil count at least 1,500/mm3
• Platelet count at least 100,000/mm3
• Hemoglobin greater than 9 g/dL
• 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

• Creatinine less than 1.5 times upper limit of normal (ULN)

  OR

• BUN 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

• No peripheral neuropathy grade 2 or greater
• No active infection
• No other serious concurrent medical illness
• No concurrent illness that may obscure toxicity or dangerously alter drug metabolism
• No other malignancy within the past 3 years except nonmelanoma skin cancer or carcinoma in situ of the cervix
• Must participate in the System for Thalidomide Education and Prescribing Safety program
• 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 48 patients (32 with glioblastoma multiforme and 16 with anaplastic glioma) will be accrued for this study within 2 years.

Outline

This is a multicenter study.

Patients receive oral thalidomide once daily and oral celecoxib twice daily on days 1-42, oral etoposide once daily on days 1-21, and oral cyclophosphamide once daily on days 22-42. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.

Patients are followed every 2 months.

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		Trial Of Oral Thalidomide, Celecoxib, Etoposide And Cyclophosphamide In Adult Patients With Relapsed Or Progressive Malignant Gliomas
Trial Start Date		2002-03-18
Registered in ClinicalTrials.gov		NCT00047281
Date Submitted to PDQ		2002-08-26
Information Last Verified		2004-11-08
NCI Grant/Contract Number		P30-CA06516

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