Temozolomide, Thalidomide, and Celecoxib Following Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme

NCT00047294 | Completed Phase 2 DMC FDA Drug

• 5 other identifiers: 00302P30CA006516CDR0000257587NCI-G02-2118CELGENE-2000-P-002521/1
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Brain and Central Nervous System Tumors

Keywords

adult mixed glioma; adult glioblastoma; adult giant cell glioblastoma; adult gliosarcoma

Interventions

celecoxib DRUG

temozolomide DRUG

thalidomide DRUG

adjuvant therapy PROCEDURE

Eligibility Criteria

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

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

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

Study Sites (4)

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

Cancer Center at the University of Virginia

Charlottesville, Virginia, 22908, United States

Location

Related Publications (1)

• Kesari S, Schiff D, Henson JW, Muzikansky A, Gigas DC, Doherty L, Batchelor TT, Longtine JA, Ligon KL, Weaver S, Laforme A, Ramakrishna N, Black PM, Drappatz J, Ciampa A, Folkman J, Kieran M, Wen PY. Phase II study of temozolomide, thalidomide, and celecoxib for newly diagnosed glioblastoma in adults. Neuro Oncol. 2008 Jun;10(3):300-8. doi: 10.1215/15228517-2008-005. Epub 2008 Apr 10.

  PMID: 18403492 RESULT

MeSH Terms

Conditions

Central Nervous System Neoplasms; Glioma; Glioblastoma; Gliosarcoma

Interventions

Celecoxib; Temozolomide; Thalidomide; Chemotherapy, Adjuvant

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; Astrocytoma

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; Dacarbazine; Triazenes; Imidazoles; Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Piperidones; Piperidines; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Combined Modality Therapy; Therapeutics; Drug Therapy

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: April 1, 2001
• Primary Completion: March 1, 2005
• Study Completion: September 1, 2007
• Last Updated: July 11, 2017

Record last verified: 2005-05

Locations

US (4)