NCT00460031

Treating Patients With Prostate Cancer That Did Not Respond to Hormone Therapy

Phase II Trial to Assess the Activity of Ketoconazole Plus Lenalidomide in Patients With Prostate Cancer Progressive After Androgen Deprivation

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: Case Comprehensive Cancer Center · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Androgens can cause the growth of prostate cancer cells. Drugs, such as ketoconazole, may stop the adrenal glands from making androgens. Lenalidomide may stop the growth of prostate cancer by blocking blood flow to the tumor. Giving ketoconazole and hydrocortisone together with lenalidomide may be an effective treatment for prostate cancer. PURPOSE: This phase II trial is studying how well giving ketoconazole and hydrocortisone together with lenalidomide works in treating patients with prostate cancer that did not respond to hormone therapy.

Detailed description

OBJECTIVES: Primary * Determine the objective response frequency in patients with hormone-refractory progressive prostate cancer treated with ketoconazole, hydrocortisone, and lenalidomide. Secondary * 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 T-regulatory cells. After completion of study therapy, patients are followed at 30 days. PROJECTED ACCRUAL: A total of 34 patients will be accrued for this study.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
DRUG	ketoconazole	400 tid
DRUG	lenalidomide	Lenalidomide will be administered daily at a dose of 25mg po qd on days 1-21 of the cycle.
DRUG	therapeutic hydrocortisone	20mg qam 10mg qhs

Timeline

• Start date: 2006-09-01
• Primary completion: 2010-08-31
• Completion: 2010-08-31
• First posted: 2007-04-13
• Last updated: 2020-07-24
• Results posted: 2015-12-09

Locations

6 sites across 1 country: United States