Brain and Central Nervous System Tumors Clinical Trial
Official title:
Phase II Study of Penicillamine and Reduction of Copper for Angiosuppressive Therapy of Adults With Newly Diagnosed Glioblastoma
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.
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.
;
Primary Purpose: Treatment
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