Phase II Trial to Assess the Activity of Ketoconazole Plus Lenalidomide in Patients With Prostate Cancer Progressive After Androgen Deprivation
- Determine the objective response frequency in patients with hormone-refractory
progressive prostate cancer treated with ketoconazole, hydrocortisone, and
- Determine the effect of this regimen on time to clinical progression in these patients.
- Determine the safety of this regimen in these patients.
- Determine the effects of this regimen on serum cytokines, including tumor necrosis
factor-alpha, basic fibroblast growth factor, plasma soluble interleukin (IL)-2
receptor, IL-8, and IL-12, as well as serum vascular endothelial growth factor levels
in these patients.
- Determine the co-stimulatory effects of this regimen on dendritic cells and
CD4-positive, CD25-positive, T-regulatory cells in these patients.
OUTLINE: This is a nonrandomized, open-label study.
Patients receive oral ketoconazole 3 times daily and oral hydrocortisone twice daily on days
1-28 and oral lenalidomide once daily on days 1-21. Courses repeat every 28 days in the
absence of disease progression or unacceptable toxicity.
Patients undergo blood collection periodically during study for evaluation of prostate
cancer-specific immune response. Blood samples are assessed by serum analysis, flow
cytometry, real-time PCR, and enzyme-linked immunosorbent assay techniques to detect and
quantify different cytokines, antiangiogenic markers, dendritic cells, and specific
After completion of study therapy, patients are followed at 30 days.
PROJECTED ACCRUAL: A total of 34 patients will be accrued for this study.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Objective response (complete and partial response) based on PSA or measurable disease
Patients will be evaluated for clinical benefit monthly with PSA values.Patients who are benefiting from treatment are eligible for additional cycles of treatment. Thereafter, therapy willcontinue until criteria for progressive disease are met.
Jorge Garcia, MD
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
United States: Food and Drug Administration
|Lake/University Ireland Cancer Center||Mentor, Ohio 44060|
|Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center||Cleveland, Ohio 44106-5065|
|UHHS Chagrin Highlands Medical Center||Orange Villager, Ohio 44122|
|University Suburban Health Center||South Euclid, Ohio 44121|
|UHHS Westlake Medical Center||Westlaker, Ohio 44145|
|Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center||Cleveland, Ohio 44195|