RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs such as tamoxifen may make the tumor cells more sensitive to radiation therapy. PURPOSE: Phase II trial to study the effectiveness of combining radiation therapy with tamoxifen in treating patients who have newly diagnosed supratentorial glioblastoma multiforme.
OBJECTIVES: I. Determine whether high-dose tamoxifen initiated at the beginning of conventional radiotherapy improves the median survival time of adults with newly diagnosed, supratentorial glioblastoma multiforme. II. Determine the feasibility and toxicity of high-dose tamoxifen in these patients. III. Determine the overall survival with respect to protein kinase C lab correlates in patients treated with this regimen. OUTLINE: This is a multicenter study. Beginning within 5 weeks after surgery, patients undergo radiotherapy to the brain 5 days a week for 6 weeks. Patients receive high-dose oral tamoxifen every 6 hours beginning on day 1 of radiotherapy and continuing in the absence of disease progression. Patients are followed every 3 months through year 1, every 4 months for 1 year, every 6 months for 2 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 72 patients will be accrued for this study within 6 months.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
77
Overall Survival
Time frame: From registration to date of death or last follow-up. Analysis occurs after all patients have been potentially followed for 18 months.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
University of Alabama at Birmingham Comprehensive Cancer Center
Birmingham, Alabama, United States
Huntsville Hospital System
Huntsville, Alabama, United States
Comprehensive Cancer Institute of Huntsville
Huntsville, Alabama, United States
MBCCOP - Gulf Coast
Mobile, Alabama, United States
Alabama Oncology, LLC
Montgomery, Alabama, United States
Radiation Oncology Associates of West Alabama
Tuscaloosa, Alabama, United States
Providence Alaska Medical Center
Anchorage, Alaska, United States
Arizona Cancer Center
Tucson, Arizona, United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
Mount Diablo Medical Center
Concord, California, United States
...and 247 more locations