Status:
COMPLETED
Treating Patients With Prostate Cancer That Did Not Respond to Hormone Therapy
Lead Sponsor:
Case Comprehensive Cancer Center
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE2
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 ...
Detailed Description
OBJECTIVES: Primary * Determine the objective response frequency in patients with hormone-refractory progressive prostate cancer treated with ketoconazole, hydrocortisone, and lenalidomide. Seconda...
Eligibility Criteria
Inclusion
- PATIENTS WITH PROSTATE CANCER PROGRESSIVE AFTER ANDROGEN DEPRIVATION Inclusion Criteria Understand and voluntarily sign an informed consent form. Age 18 years at the time of signing the informed consent form. Histologically confirmed adenocarcinoma of the prostate. Testosterone less than 50 ng/dL. Patients must continue primary androgen deprivation with an LHRH analogue if they have not undergone orchiectomy. All previous cancer therapy, including radiation, and surgery, must have been discontinued at least 4 weeks prior to receive first dose of study drug.
- Progressive disease after androgen deprivation.
- Exclusion Criteria Prior systemic chemotherapy for hormone refractory prostate cancer. Prior neoadjuvant and adjuvant chemotherapy are allowed when completed at least 12 months prior to enrollment.
- Prior ketoconazole, aminoglutethimide or corticosteroids for the treatment of progressive prostate cancer.
- Prior immunotherapy including, but not limited to, vaccines, Thalidomide, and or Lenalidomide like agents.
- Supplements or complementary medicines/botanicals are not permitted while on protocol therapy, except for any combination of the following:
- conventional multivitamin supplements selenium lycopene soy supplements Patients should review the label with their doctor prior to enrollment, and discontinue disallowed agents prior to study enrollment Serious intercurrent infections or non-malignant medical illnesses including autoimmune disorders that are uncontrolled.
- Psychiatric illnesses/social situations that would limit compliance with protocol requirements.
- Evidence of CNS (brain or Leptomeningeal) metastases or large pleural/pericardial effusions.
- Known contraindication to receive Ketoconazole or Lenalidomide Concurrent use of ketoconazole with statin compounds is absolutely contraindicated. Thus, patients receiving Statin drugs (fluvastatin, atorvastatin, and simvastatin) should discontinue them for at least 7 days before starting ketoconazole.
- Patients taking astemizole, terfenadine, or cisapride, rifampin or isoniazid are not eligible, unless they agreed to completely discontinue those agents. In that case, any of these agents should be discontinued at least 7 days prior to start therapy with Ketoconazole.
- Use of any other experimental drug or therapy within 28 days of baseline. Known hypersensitivity to thalidomide or its analogues. Any prior use of Lenalidomide. Known positive for HIV or infectious hepatitis, type A, B or C. Disease free of prior malignancies for 5 years with exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma "insitu" of the breast.
Exclusion
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 31 2010
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT00460031
Start Date
September 1 2006
End Date
August 31 2010
Last Update
July 24 2020
Active Locations (6)
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1
Lake/University Seidman Cancer Center
Cleveland, Ohio, United States, 44060
2
University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44106-5065
3
University Suburban Health Center
Cleveland, Ohio, United States, 44121
4
UHHS Chagrin Highlands Medical Center
Cleveland, Ohio, United States, 44122