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| Sponsors and Collaborators: |
Case Comprehensive Cancer Center National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00460031 |
Purpose
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.
| Condition | Intervention | Phase |
|
Prostate Cancer |
Drug: ketoconazole Drug: lenalidomide Drug: therapeutic hydrocortisone Procedure: flow cytometry Procedure: immunoenzyme technique Procedure: immunohistochemistry staining method Procedure: laboratory biomarker analysis Procedure: polymerase chain reaction |
Phase II |
| MedlinePlus related topics: | Cancer Prostate Cancer |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label |
| Official Title: | Phase II Trial to Assess the Activity of Ketoconazole Plus Lenalidomide in Patients With Prostate Cancer Progressive After Androgen Deprivation |
| Estimated Enrollment: | 34 |
| Study Start Date: | February 2007 |
OBJECTIVES:
Primary
Secondary
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.
Eligibility
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Progressive disease after androgen deprivation therapy, defined by 1 of the following:
No measurable disease AND meets 1 of the following criteria:
Demonstrates disease progression after antiandrogen withdrawal, as defined by 1 of the following:
Testosterone < 50 ng/dL
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
No prior systemic chemotherapy for prostate cancer
No concurrent supplements or complementary medicines/botanicals, except for any combination of the following:
Concurrent bisphosphonates allowed provided the following criteria are met:
Concurrent acetylsalicylic acid or warfarin allowed for deep vein thrombosis (DVT) prophylaxis provided the following criteria are met:
No concurrent use of the following drugs:
Contacts and Locations| United States, Ohio | |||||
| Case Comprehensive Cancer Center | Recruiting | ||||
| Cleveland, Ohio, United States, 44106-5065 | |||||
| Contact: Clinical Trials Office - Case Comprehensive Cancer Center 800-641-2422 | |||||
| Cleveland Clinic Taussig Cancer Center | Recruiting | ||||
| Cleveland, Ohio, United States, 44195 | |||||
| Contact: Clinical Trials Office - Cleveland Clinic Taussig Cancer Cente 866-223-8100 | |||||
| Geauga Regional Hospital | Recruiting | ||||
| Chardonr, Ohio, United States, 44024 | |||||
| Contact: Matthew M Cooney 216-691-0100 | |||||
| Lake/University Ireland Cancer Center | Recruiting | ||||
| Mentor, Ohio, United States, 44060 | |||||
| Contact: Matthew M Cooney 216-691-0100 | |||||
| University Suburban Health Center | Recruiting | ||||
| South Euclid, Ohio, United States, 44121 | |||||
| Contact: Matthew M Cooney 216-691-0100 | |||||
| Southwest General Health Center | Recruiting | ||||
| Middleburgh Heights, Ohio, United States, 44130 | |||||
| Contact: Matthew M Cooney 216-691-0100 | |||||
| UHHS Chagrin Highlands Medical Center | Recruiting | ||||
| Orange Villager, Ohio, United States, 44122 | |||||
| Contact: Matthew M Cooney 216-691-0100 | |||||
| UHHS Westlake Medical Center | Recruiting | ||||
| Westlaker, Ohio, United States, 44145 | |||||
| Contact: Matthew M Cooney 216-691-0100 | |||||
| Mercy Cancer Center at Mercy Medical Center | Recruiting | ||||
| Canton, Ohio, United States, 44708 | |||||
| Contact: Matthew M Cooney 216-691-0100 | |||||
| Case Comprehensive Cancer Center |
| National Cancer Institute (NCI) |
| Principal Investigator: | Matthew M. Cooney, MD | Case Comprehensive Cancer Center |
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database 
  |
| Study ID Numbers: | CDR0000540496, CASE-12805, CELGENE-CASE-12805 |
| First Received: | April 11, 2007 |
| Last Updated: | October 22, 2008 |
| ClinicalTrials.gov Identifier: | NCT00460031 |
| Health Authority: | Unspecified |
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