Celecoxib in Patients With Newly Diagnosed GBM Who Are Receiving Anticonvulsant Drugs and Undergoing RT
Condition: Brain and Central Nervous System Tumors
MeSH terms: Nervous System Neoplasms; Central Nervous System Neoplasms
Intervention: radiation therapy; Celecoxib
Intervention description: Radiation is standard treatment 6000cGy in 30 fractions. Patients will receive celecoxib 400 mg bid during RT treatment; Celecoxib will begin 1 week prior to RT at 400mg bid orally. One day 1 only 1 dose will be administered. Starting on day 2 and throughout treatment until progression, 2 doses will be administered at least 12 hours apart. Celecoxib will continue throughout the 6 week course of RT.
Intervention MeSH terms: Celecoxib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 35.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: adult glioblastoma; adult giant cell glioblastoma; adult gliosarcoma

Summary:

      RATIONALE: Celecoxib may stop the growth of tumor cells by blocking the enzymes necessary for
      their growth. It is not yet known whether the effectiveness of celecoxib in treating
      glioblastoma multiforme is decreased in patients who are receiving anticonvulsant drugs and
      undergoing radiation therapy.

      PURPOSE: Phase II trial to study the effectiveness of celecoxib in treating patients who are
      receiving anticonvulsant drugs and undergoing radiation therapy for newly diagnosed
      glioblastoma multiforme.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically confirmed glioblastoma multiforme

               -  Supratentorial

               -  Grade IV astrocytoma

        PATIENT CHARACTERISTICS:

        Age

          -  18 and over

        Performance status

          -  Karnofsky 60-100%

        Life expectancy

          -  Not specified

        Hematopoietic

          -  Absolute neutrophil count at least 1,500/mm^3

          -  Platelet count at least 100,000/mm^3

          -  Hemoglobin at least 9.0 g/dL

        Hepatic

          -  Bilirubin no greater than 1.5 mg/dL

          -  Transaminases no greater than 4 times upper limit of normal

        Renal

          -  Creatinine no greater than 1.7 mg/dL

          -  Creatinine clearance at least 60 mL/min

          -  No prior renal toxicity with nonsteroidal anti-inflammatory drugs

        Other

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception

          -  Mini mental score at least 15

          -  No history of peptic disease

          -  No serious concurrent infection

          -  No other medical illness that would preclude study participation

          -  No other malignancy within the past 5 years except curatively treated carcinoma in
             situ or basal cell skin cancer

          -  No allergy to sulfonamides

          -  Able to tolerate cyclo-oxygenase-2 (COX-2) inhibitors

        PRIOR CONCURRENT THERAPY:

        Biologic therapy

          -  No prior immunotherapy or biologic agents for the malignancy, including any of the
             following:

               -  Immunotoxins

               -  Immunoconjugates

               -  Antisense agents

               -  Peptide receptor antagonists

               -  Interferons

               -  Interleukins

               -  Tumor-infiltrating lymphocytes

               -  Lymphokine-activated killer cells

               -  Gene therapy

          -  No concurrent prophylactic growth factors (e.g., filgrastim [G-CSF] or sargramostim
             [GM-CSF])

        Chemotherapy

          -  No prior chemotherapy for the malignancy

        Endocrine therapy

          -  No prior hormonal therapy for the malignancy

          -  Prior glucocorticoid therapy allowed

          -  Concurrent corticosteroids allowed provided there has been no dose increase within the
             past 5 days

        Radiotherapy

          -  No prior radiotherapy for the malignancy

        Surgery

          -  Recovered from prior surgery

        Other

          -  At least 1 week since prior fluconazole

          -  More than 10 days since prior anticonvulsant drugs that induce hepatic metabolic
             enzymes (Group A)

          -  No other prior therapy for the malignancy

          -  No concurrent enrollment in another therapeutic clinical trial

          -  No concurrent fluconazole