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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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 Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT00047294
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Dana-Farber Cancer Institute
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Patrick Y. Wen, MD
Principal Investigator Affiliation Dana-Farber Cancer Institute
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other, NIH
Overall Status Completed
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Brain and Central Nervous System Tumors
Additional Details

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Boston, Massachusetts

Status

Address

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, 02114

Brigham and Women's Hospital, Boston, Massachusetts

Status

Address

Brigham and Women's Hospital

Boston, Massachusetts, 02115

Boston, Massachusetts

Status

Address

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

Boston, Massachusetts, 02115

Charlottesville, Virginia

Status

Address

Cancer Center at the University of Virginia

Charlottesville, Virginia, 22908

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