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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2005 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00047294
First received: October 3, 2002
Last updated: February 6, 2009
Last verified: May 2005
  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 2

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study Of Temozolomide, Thalidomide And Celecoxib In Patients With Newly Diagnosed Glioblastoma Multiforme In The Post-Radiation Setting

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00047294     History of Changes
Other Study ID Numbers: CDR0000257587, DFCI-00302, NCI-G02-2118, CELGENE-2000-P-002521/1
Study First Received: October 3, 2002
Last Updated: February 6, 2009
Health Authority: United States: Federal Government

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

Additional relevant MeSH terms:
Central Nervous System Neoplasms
Glioblastoma
Nervous System Neoplasms
Astrocytoma
Glioma
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Germ Cell and Embryonal
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Neoplasms, Neuroepithelial
Nervous System Diseases
Neuroectodermal Tumors
Celecoxib
Temozolomide
Thalidomide
Alkylating Agents
Analgesics
Analgesics, Non-Narcotic
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Anti-Bacterial Agents
Anti-Infective Agents
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on October 23, 2014