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Temozolomide, Thalidomide, and Celecoxib Following Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme
This study is ongoing, but not recruiting participants.
Sponsors and Collaborators: Dana-Farber Cancer Institute
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00047294
  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.


Condition Intervention Phase
Brain and Central Nervous System Tumors
Drug: celecoxib
Drug: temozolomide
Drug: thalidomide
Procedure: adjuvant therapy
Phase II

MedlinePlus related topics: Cancer
Drug Information available for: Temozolomide Thalidomide Celecoxib 4-(5-(4-Methylphenyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl)benzenesulfonamide
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: Phase II Study Of Temozolomide, Thalidomide And Celecoxib In Patients With Newly Diagnosed Glioblastoma Multiforme In The Post-Radiation Setting

Further study details as provided by National Cancer Institute (NCI):

Study Start Date: April 2002
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00047294

Locations
United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States, 02114
United States, Virginia
Cancer Center at the University of Virginia
Charlottesville, Virginia, United States, 22908
Sponsors and Collaborators
Dana-Farber Cancer Institute
Investigators
Study Chair: Patrick Y. Wen, MD Dana-Farber Cancer Institute
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Publications of Results:
Study ID Numbers: CDR0000257587, DFCI-00302, NCI-G02-2118, CELGENE-2000-P-002521/1
Study First Received: October 3, 2002
Last Updated: December 11, 2008
ClinicalTrials.gov Identifier: NCT00047294  
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
adult mixed glioma
adult glioblastoma
adult giant cell glioblastoma
adult gliosarcoma

Study placed in the following topic categories:
Glioblastoma
Celecoxib
Astrocytoma
Thalidomide
Central Nervous System Neoplasms
Temozolomide
Neuroectodermal Tumors
Glioblastoma multiforme
Neoplasms, Germ Cell and Embryonal
Neuroepithelioma
Glioma
Gliosarcoma
Nervous System Neoplasms
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Anti-Inflammatory Agents
Anti-Infective Agents
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Neoplasms, Nerve Tissue
Anti-Bacterial Agents
Neoplasms by Site
Sensory System Agents
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Angiogenesis Modulating Agents
Growth Inhibitors
Alkylating Agents
Neoplasms by Histologic Type
Growth Substances
Nervous System Diseases
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Immunosuppressive Agents
Angiogenesis Inhibitors
Pharmacologic Actions
Neoplasms
Analgesics, Non-Narcotic
Peripheral Nervous System Agents
Antineoplastic Agents, Alkylating
Antirheumatic Agents
Neoplasms, Neuroepithelial

ClinicalTrials.gov processed this record on January 15, 2009