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Alternate Title
Basic Trial Information
Trial Description
     Purpose
     Eligibility
     Treatment/Intervention
Trial Contact Information
Registry Information

Alternate Title

Phase II Study of Ketoconazole, Hydrocortisone, and Lenalidomide in Patients With Prostate Cancer That Progressed After Androgen Deprivation Therapy

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Biomarker/Laboratory analysis, Treatment	Closed	18 and over	NCI, Pharmaceutical / Industry	CASE-12805 CASE 12805, CELGENE-CASE-12805, NCT00460031

Trial Description

Purpose:

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.

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.

Eligibility:

Eligibility criteria include the following:

• At least 18 years old
• No CNS metastases
• At least 4 weeks since radiation therapy, surgery, megestrol, finasteride, saw palmetto, PC-SPES, or other treatment for cancer
• At least 8 weeks since strontium-89, samarium Sm 153 lexidronam pentasodium, or other radiopharmaceuticals
• At least 6 weeks since bicalutamide or nilutamide
• At least 4 weeks since flutamide
• No previous chemotherapy for prostate cancer
• No previous vaccine therapy, GM-CSF, thalidomide, lenalidomide or other biological therapy
• For more information about the eligibility criteria for this trial, refer to the Health Professional version.

Final eligibility for a clinical trial is determined by the health professionals conducting the trial.

Treatment/Intervention:

Patients will receive ketoconazole by mouth three times a day and hydrocortisone by mouth twice a day for 4 weeks. They will also receive lenalidomide by mouth once a day for 3 weeks. Courses may repeat every 4 weeks for as long as benefit is shown.

Patients will undergo blood sample collection periodically for laboratory studies.

After finishing treatment, patients will be evaluated at 1 month.

Important:

For more details about this trial, refer to the Health Professional version of the trial summary.

If you are interested in participating in a clinical trial, contact your doctor for a referral or call a trial contact person listed below. You may see the same contact person listed at more than one site, however, if you call the number listed you can ask to speak to the study coordinator or person involved with the specific trial you are interested in. If you have questions about cancer or clinical trials, call the Cancer Information Service at 1-800-4-CANCER (1-800-422-6237). General information about clinical trials, including risks, benefits, and costs, can be found on NCI's Web site.

Trial Contact Information

Trial Lead Organizations

Case Comprehensive Cancer Center

Matthew Cooney, MD, Principal investigator		Ph: 216-691-0100

Registry Information
Official Title		Phase II Trial to Assess the Activity of Ketoconazole Plus Lenalidomide in Patients with Prostate Cancer Progressive after Androgen Deprivation
Trial Start Date		2007-02-20
Registered in ClinicalTrials.gov		NCT00460031
Date Submitted to PDQ		2007-02-20
Information Last Verified		2009-04-02
NCI Grant/Contract Number		CA43703

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