Ignite Creation Date:
2024-05-05 @ 5:29 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00460031
Status:
COMPLETED
Last Update Posted:
2020-07-24
First Post:
2007-04-11
Brief Title:
Treating Patients With Prostate Cancer That Did Not Respond to Hormone Therapy
Sponsor:
Case Comprehensive Cancer Center
Organization:
Case Comprehensive Cancer Center
Study Overview
Official Title:
Phase II Trial to Assess the Activity of Ketoconazole Plus Lenalidomide in Patients With Prostate Cancer Progressive After Androgen Deprivation
Status:
COMPLETED
Status Verified Date:
2020-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None