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

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ClinicalTrials.gov Identifier: NCT00047281
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : July 11, 2017
Sponsor:
Collaborators:
National Cancer Institute (NCI)
Schering-Plough
Celgene
Information provided by (Responsible Party):
Patrick Y. Wen, MD, Dana-Farber Cancer Institute

Tracking Information
First Submitted Date  ICMJE October 3, 2002
First Posted Date  ICMJE January 27, 2003
Last Update Posted Date July 11, 2017
Actual Study Start Date  ICMJE March 2004
Actual Primary Completion Date August 2005   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE Not Provided
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00047281 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Outcome Measures  ICMJE Not Provided
Original Other Outcome Measures  ICMJE Not Provided
 
Descriptive Information
Brief Title  ICMJE Thalidomide, Celecoxib, and Combination Chemotherapy in Treating Patients With Relapsed or Refractory Malignant Glioma
Official Title  ICMJE Trial Of Oral Thalidomide, Celecoxib, Etoposide And Cyclophosphamide In Adult Patients With Relapsed Or Progressive Malignant Gliomas
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.

Detailed Description

OBJECTIVES:

  • Determine the efficacy of thalidomide, celecoxib, etoposide, and cyclophosphamide, in terms of 6-month progression-free survival, in patients with relapsed or refractory malignant glioma.
  • Determine the overall survival of patients treated with this regimen.
  • Determine the toxic effects of this regimen in these patients.
  • Determine the radiographic response in patients treated with this regimen.

OUTLINE: This is a multicenter study.

Patients receive oral thalidomide once daily and oral celecoxib twice daily on days 1-42, oral etoposide once daily on days 1-21, and oral cyclophosphamide once daily on days 22-42. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.

Patients are followed every 2 months.

PROJECTED ACCRUAL: A total of 48 patients (32 with glioblastoma multiforme and 16 with anaplastic glioma) will be accrued for this study within 2 years.

Study Type  ICMJE Interventional
Study Phase Phase 2
Study Design  ICMJE Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Brain and Central Nervous System Tumors
Intervention  ICMJE
  • Drug: celecoxib
  • Drug: cyclophosphamide
  • Drug: etoposide
  • Drug: thalidomide
Study Arms Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE Not Provided
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date February 2006
Actual Primary Completion Date August 2005   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 120 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00047281
Other Study ID Numbers  ICMJE 01-278
P30CA006516 ( U.S. NIH Grant/Contract )
CDR0000257584
NCI-G02-2117
CELGENE-2001-P-001757/3
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Patrick Y. Wen, MD, Dana-Farber Cancer Institute
Study Sponsor  ICMJE Dana-Farber Cancer Institute
Collaborators  ICMJE
  • National Cancer Institute (NCI)
  • Schering-Plough
  • Celgene
Investigators  ICMJE
Study Chair: Patrick Y. Wen, MD Dana-Farber Cancer Institute
PRS Account Dana-Farber Cancer Institute
Verification Date July 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP