At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase II Trial of Neoadjuvant GM-CSF + Thalidomide in High-Risk Patients With Prostate Cancer Undergoing Prostatectomy
In Brief
A Phase 2 clinical trial evaluating sargramostim, thalidomide, and 2 other interventions for Prostate Cancer. Completed, enrolled 28 participants across 1 site.
Detailed Summary
RATIONALE: Biological therapies, such as GM-CSF, may stimulate the immune system in different ways and stop tumor cells from growing. Thalidomide may stop the growth of prostate cancer by blocking blood flow to the tumor. Giving GM-CSF and thalidomide before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. PURPOSE: This phase II trial is studying how well giving GM-CSF together with thalidomide works in treating patients undergoing surgery for high-risk prostate cancer.
Study Details
Timeline
Interventions
administered subcutaneously, generally well tolerated doses range from 50-500 ug/m2/day
doses up to 400 mg/day
SOC care surgery
post radical prostatectomy