Temozolomide Alone or in Combination With Thalidomide and/or Isotretinoin and/or Celecoxib in Treating Patients Who Have Undergone Radiation Therapy for Glioblastoma Multiforme
Condition: Brain and Central Nervous System Tumors; Glioblastoma Multiforme
MeSH terms: Glioblastoma; Nervous System Neoplasms; Central Nervous System Neoplasms
Intervention: Celecoxib; Isotretinoin; Temozolomide; Thalidomide
Intervention description: 400 mg orally twice a day continuous dosing; 40 mg/m^2 orally twice a day (total daily dose = 80 mg/m^2) days 1-21 of a 28 day cycle.; 150 mg/m2 orally daily, 7 days on treatment, 7 days off.; 400 mg orally every day continuous dosing (starting at 200 mg each day and escalating weekly by 100 mg until the maximum dose of 400 mg/day is achieved)
Intervention MeSH terms: Thalidomide; Celecoxib; Temozolomide; Isotretinoin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 178.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: adult giant cell glioblastoma; adult gliosarcoma; adult glioblastoma

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 stop the growth of glioblastoma multiforme by blocking blood flow to the
      tumor. Isotretinoin may help cells that are involved in the body's immune response to work
      better. Celecoxib may stop the growth of tumor cells by blocking some of the enzymes needed
      for cell growth. It is not yet known which temozolomide-containing regimen is more effective
      in treating glioblastoma multiforme.

      PURPOSE: This randomized phase II trial is studying eight different temozolomide-containing
      regimens to compare how well they work in treating patients who have undergone radiation
      therapy for glioblastoma multiforme.
    

Eligibility criteria:

        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