Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Trial Description

Summary

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.

Further Study Information

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.

Eligibility 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

Trial Contact Information

Trial Lead Organizations/Sponsors

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

Patrick Y. Wen

Study Chair

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00047294
Information obtained from ClinicalTrials.gov on December 14, 2011

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