Contrast-Enhanced Radiotherapy With GM-CSF Immune Stimulation - Phase I/II Clinical Center Treatment Trial
- Determine the safety of contrast-enhanced high-dose radiotherapy administered with
sargramostim (GM-CSF) in patients with advanced solid malignancies.
- Determine immune response in patients treated with this regimen.
- Determine tumor response in patients treated with this regimen.
OUTLINE: Patients are stratified according to prior therapy (biopsy or simple surgery vs
radical surgery, chemotherapy, or radiotherapy).
Patients receive a contrast agent intratumorally followed by a single fraction of
kilovoltage radiotherapy. Beginning 24 hours after radiotherapy, patients receive
sargramostim (GM-CSF) intratumorally continuously for 1 week and then subcutaneously for 2
weeks. Patients with lung tumors receive GM-CSF by inhalation twice daily for 1 week and
then every other week for a total of 3 weeks of drug treatment.
Treatment may repeat in several weeks in the absence of disease progression or unacceptable
Patients are followed every 8 weeks.
PROJECTED ACCRUAL: A total of 47 patients (12 for phase I and 35 for phase II) will be
accrued for this study.
Masking: Open Label, Primary Purpose: Treatment
Toxicity as measured by the Southwest Oncology Group Performance Status and Toxicity Criteria on day 1 and in weeks 4, 12, and 20
Michael D. Weil, MD
United States: Federal Government
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