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

NCT ID: NCT00047281

Last Updated: 2017-07-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-03-31
• Study Completion Date: 2006-02-28

Brief 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.

Detailed Description

OBJECTIVES:

• 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.
• Determine the overall survival of patients treated with this regimen.
• Determine the toxic effects of this regimen in these patients.
• Determine the radiographic response in patients treated with this regimen.

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.

PROJECTED ACCRUAL: A total of 48 patients (32 with glioblastoma multiforme and 16 with anaplastic glioma) will be accrued for this study within 2 years.

Conditions

Brain and Central Nervous System Tumors

Study Design

• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

celecoxib

Intervention Type: DRUG

cyclophosphamide

Intervention Type: DRUG

etoposide

Intervention Type: DRUG

thalidomide

Intervention Type: DRUG

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Schering-Plough

INDUSTRY

Sponsor Role: collaborator

Celgene

INDUSTRY

Sponsor Role: collaborator

Dana-Farber Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

Patrick Y. Wen, MD

Director, Center for Neuro-Oncology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Patrick Y. Wen, MD

Role: STUDY_CHAIR

Dana-Farber Cancer Institute

Locations

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, United States

Brigham and Women's Hospital

Boston, Massachusetts, United States

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

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

P30CA006516

Identifier Type: NIH

Identifier Source: secondary_id

View Link

CDR0000257584

Identifier Type: -

Identifier Source: secondary_id

NCI-G02-2117

Identifier Type: -

Identifier Source: secondary_id

CELGENE-2001-P-001757/3

Identifier Type: -

Identifier Source: secondary_id

01-278

Identifier Type: -

Identifier Source: org_study_id