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

• Status: Completed
• Trial end date: 2006-02-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Thalidomide and celecoxib may stop the growth of tumor cells by stopping blood flow to the tumor. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining thalidomide and celecoxib with etoposide and cyclophosphamide may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combining thalidomide and celecoxib with etoposide and cyclophosphamide in treating patients who have relapsed or refractory malignant glioma.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dana-Farber Cancer Institute
• Collaborators: Celgene; National Cancer Institute (NCI); Schering-Plough
• Treatments: Celecoxib; Cyclophosphamide; Etoposide; Etoposide phosphate; Thalidomide

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

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

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