Finding studies
Finding studies
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Lead
Robert Dreicer MD
With
OBJECTIVES: * Establish the safety of a predetermined target dose or, if the target dose is not tolerable, find the maximum tolerated dose of lenalidomide when administered in combination with sargramostim in patients with androgen-independent prostate cancer. * Evaluate the preliminary efficacy of this regimen to ascertain whether additional study of lenalidomide is warranted in patients with androgen-independent prostate cancer. * Evaluate the safety of this regimen in these patients. * Describe the effects of this regimen on serum cytokines (e.g., TNF-α, bFGF, sIL2R, IL-8, and IL-12) and on serum VEGF levels. * Assess the co-stimulatory effects of this regimen on CD4+, CD8+, CD83, and CD86 cells. OUTLINE: This is a phase I, dose-escalation study of lenalidomide followed by a phase II study. Patients receive oral lenalidomide on days 1-21 and sargramostim subcutaneously on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, and 26. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Blood samples are collected periodically for correlative biomarker and immunological laboratory studies. After completion of study therapy, patients are followed up at 30 days and then every 3 months thereafter.
Age
18–any
Sex
MALE
Healthy volunteers
Not accepted
