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Phase II Study of Penicillamine and Reduction of Copper for Angiosuppressive Therapy of Adults With Newly Diagnosed Glioblastoma (NCT00003751)

National Cancer Institute (NCI)
RATIONALE: Penicillamine may stop the growth of glioblastomas by stopping blood flow to the tumor. A diet low in copper may interfere with the growth of brain tumor cells. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining these therapies may be effective in treating glioblastoma. PURPOSE: Phase II trial to study the effectiveness of penicillamine, a low copper diet, and radiation therapy in treating patients who have newly diagnosed glioblastoma.
  • Drug: penicillamine
    • Radiation: radiation therapy
      Ages eligible for Study
      18 Years and older
      Genders eligible for Study
      All
      Accepts Healthy Volunteers
      No
      OBJECTIVES: I. Determine the effect of penicillamine and copper reduction on survival and time to progression in adults with newly diagnosed glioblastoma. II. Determine the effect of penicillamine on the reduction of serum copper in these patients. III. Determine whether penicillamine reduces the tumor volume, vascularity, invasion, and edema in these patients.

      OUTLINE: Patients receive oral penicillamine on the following schedule: Week 1: once daily Week 2: two times daily Week 3: three times daily Week 4: four times daily Week 5 to end of study: increased dose four times daily. Patients also receive oral pyridoxine daily and maintain a low copper diet (no greater than 0.5 mg/day). This regimen is continued for up to 2 years in the absence of disease progression or unacceptable toxicity. Radiotherapy is administered over 6 weeks, beginning on day 1 of penicillamine therapy. Patients are followed every month (with MRI every 2 months) until death.

      PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.

      9 locations

      United States (9)
      • University of Alabama Comprehensive Cancer Center
        Not specified
        Birmingham, Alabama, United States, 35294
      • H. Lee Moffitt Cancer Center and Research Institute
        Not specified
        Tampa, Florida, United States, 33612
      • Emory University School of Medicine
        Not specified
        Atlanta, Georgia, United States, 30322
      • Johns Hopkins Oncology Center
        Not specified
        Baltimore, Maryland, United States, 21287
      • Massachusetts General Hospital Cancer Center
        Not specified
        Boston, Massachusetts, United States, 02114
      • Henry Ford Hospital
        Not specified
        Detroit, Michigan, United States, 48202
      • Comprehensive Cancer Center of Wake Forest University Baptist Medical Center
        Not specified
        Winston-Salem, North Carolina, United States, 27157-1082
      • University of Pennsylvania Cancer Center
        Not specified
        Philadelphia, Pennsylvania, United States, 19104
      • University of Texas Health Science Center at San Antonio
        Not specified
        San Antonio, Texas, United States, 78284
      Status:
      completed
      Type:
      Interventional
      Phase:
      Start:
      28 February, 1999
      Updated:
      30 April, 2012
      Participants:
      40
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