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Status:

COMPLETED

Temozolomide Alone or in Combination With Thalidomide and/or Isotretinoin and/or Celecoxib in Treating Patients Who Have Undergone Radiation Therapy for Glioblastoma Multiforme

Lead Sponsor:

M.D. Anderson Cancer Center

Collaborating Sponsors:

National Cancer Institute (NCI)

Conditions:

Brain and Central Nervous System Tumors

Glioblastoma Multiforme

Eligibility:

All Genders

18+ years

Phase:

PHASE2

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Thalidomide may st...

Detailed Description

OBJECTIVES: * Compare the efficacy of adjuvant temozolomide (TMZ) alone or in combination with thalidomide and/or isotretinoin and/or celecoxib, in terms of 6-month progression-free survival, in pati...

Eligibility Criteria

Inclusion

  • DISEASE CHARACTERISTICS:
  • Histologically confirmed supratentorial glioblastoma multiforme
  • Must have undergone a biopsy OR subtotal or gross total resection of the tumor
  • Must have completed post-operative (or post-biopsy) radiotherapy within the past 5 weeks
  • No progressive disease after radiotherapy
  • PATIENT CHARACTERISTICS:
  • Age
  • 18 and over
  • Performance status
  • Karnofsky 60-100%
  • Life expectancy
  • Not specified
  • Hematopoietic
  • Absolute neutrophil count ≥ 1,500/mm\^3
  • Platelet count ≥ 100,000/mm\^3
  • Hepatic
  • Serum glutamate pyruvate transaminase (SGPT) \< 2 times upper limit of normal (ULN)
  • Alkaline phosphatase \< 2 times ULN
  • Bilirubin ≤ 1.5 mg/dL
  • Renal
  • blood urea nitrogen (BUN) ≤ 1.5 times ULN
  • Creatinine ≤ 1.5 times ULN
  • Immunologic
  • No history of allergic reactions attributed to compounds of similar chemical or biological composition to celecoxib or to sulfonamides
  • No asthma, urticaria, or allergic reactions to aspirin or other NSAIDs
  • No active infection
  • Gastrointestinal
  • No inflammatory bowel disease
  • No history of peptic ulcer disease
  • No gastrointestinal bleeding within past 3 months
  • Other
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective double-method contraception during and for 2 months after study participation
  • Fertile female patients randomized to receive thalidomide must use effective double-method contraception for ≥ 4 weeks before, during, and ≥ 4 weeks after completion of study therapy
  • Fertile male patients randomized to receive thalidomide must use effective contraception during and for ≥ 4 weeks after completion of study therapy
  • No blood donation (for patients randomized to receive thalidomide)
  • No history of any other cancer except nonmelanoma skin cancer or carcinoma in situ of the cervix or cancer that is in complete remission and patient completed all therapy for that disease ≥ 3 years ago
  • No other disease that would obscure toxicity or dangerously alter drug metabolism (e.g., severe connective tissue disease)
  • No other serious medical illness
  • PRIOR CONCURRENT THERAPY:
  • Biologic therapy
  • Not specified
  • Chemotherapy
  • Prior temozolomide in combination with radiotherapy allowed
  • No other prior or concurrent chemotherapy
  • Endocrine therapy
  • Not specified
  • Radiotherapy
  • See Disease Characteristics
  • See Chemotherapy
  • Surgery
  • See Disease Characteristics
  • No concurrent surgery
  • Other
  • No other concurrent non-steroidal anti-inflammatory drugs (NSAIDs) (for patients randomized to receive celecoxib)
  • No other concurrent investigational drugs
  • No other concurrent anticancer therapy

Exclusion

    Key Trial Info

    Start Date :

    September 1 2005

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    September 1 2014

    Estimated Enrollment :

    178 Patients enrolled

    Trial Details

    Trial ID

    NCT00112502

    Start Date

    September 1 2005

    End Date

    September 1 2014

    Last Update

    October 18 2021

    Active Locations (12)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 3 (12 locations)

    1

    Hembree Mercy Cancer Center at St. Edward Mercy Medical Center

    Fort Smith, Arkansas, United States, 72913

    2

    University of Texas MD Anderson Cancer Center at Orlando

    Orlando, Florida, United States, 32806-2134

    3

    CCOP - Atlanta Regional

    Atlanta, Georgia, United States, 30342-1701

    4

    CCOP - Central Illinois

    Decatur, Illinois, United States, 62526