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

NCT00047281 | Completed Phase 2 DMC FDA Drug

• 5 other identifiers: 01-278P30CA006516CDR0000257584NCI-G02-2117CELGENE-2001-P-001757/3
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 3

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.

Conditions

Brain and Central Nervous System Tumors

Keywords

adult anaplastic astrocytoma; adult anaplastic oligodendroglioma; adult glioblastoma; adult mixed glioma; recurrent adult brain tumor; adult giant cell glioblastoma; adult gliosarcoma

Interventions

celecoxib DRUG

cyclophosphamide DRUG

etoposide DRUG

thalidomide DRUG

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Dana-Farber Cancer Institute: lead
• National Cancer Institute (NCI): collaborator
• Schering-Plough: collaborator
• Celgene: collaborator

Study Sites (3)

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, 02114, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

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

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Central Nervous System Neoplasms; Astrocytoma; Oligodendroglioma; Glioblastoma; Glioma; Brain Neoplasms; Gliosarcoma

Interventions

Celecoxib; Cyclophosphamide; Etoposide; Thalidomide

Condition Hierarchy (Ancestors)

Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Nervous System Diseases; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Brain Diseases; Central Nervous System Diseases

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phosphoramides; Organophosphorus Compounds; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Glucosides; Glycosides; Carbohydrates; Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Piperidones; Piperidines; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Patrick Y. Wen, MD

  Dana-Farber Cancer Institute

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Center for Neuro-Oncology

Study Record Dates

• First Submitted: October 3, 2002
• First Posted: January 27, 2003
• Study Start: March 1, 2004
• Primary Completion: August 1, 2005
• Study Completion: February 1, 2006
• Last Updated: July 11, 2017

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)