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

Phase 2
18 Years
Open (Enrolling)
Prostate Cancer

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Trial Information

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



- Determine the objective response frequency in patients with hormone-refractory
progressive prostate cancer treated with ketoconazole, hydrocortisone, and


- 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.

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

Evidence of CNS (brain or Leptomeningeal) metastases or large pleural/pericardial

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

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.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Objective response (complete and partial response) based on PSA or measurable disease

Outcome Description:

Patients will be evaluated for clinical benefit monthly with PSA values.Patients who are benefiting from treatment are eligible for additional cycles of treatment. Thereafter, therapy willcontinue until criteria for progressive disease are met.

Outcome Time Frame:

28 days

Safety Issue:


Principal Investigator

Jorge Garcia, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

February 2007

Completion Date:

July 2012

Related Keywords:

  • Prostate Cancer
  • adenocarcinoma of the prostate
  • stage III prostate cancer
  • stage IV prostate cancer
  • recurrent prostate cancer
  • Prostatic Neoplasms



Lake/University Ireland Cancer Center Mentor, Ohio  44060
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center Cleveland, Ohio  44106-5065
UHHS Chagrin Highlands Medical Center Orange Villager, Ohio  44122
University Suburban Health Center South Euclid, Ohio  44121
UHHS Westlake Medical Center Westlaker, Ohio  44145
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center Cleveland, Ohio  44195