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Lenalidomide and GM-CSF in Treating Patients With Prostate Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00939510
Recruitment Status : Completed
First Posted : July 15, 2009
Results First Posted : July 12, 2012
Last Update Posted : January 31, 2013
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Robert Dreicer MD, Case Comprehensive Cancer Center

July 14, 2009
July 15, 2009
April 26, 2012
July 12, 2012
January 31, 2013
July 2005
October 2009   (Final data collection date for primary outcome measure)
  • Number of Patients With a PSA Response [ Time Frame: reevaluated for response every eight weeks ]
    Number of patients with a PSA Response defined as a PSA decline greater or equal to 50% compared with baseline value.
  • RECIST-defined Measurable Disease [ Time Frame: every 8 weeks and at end of treatment ]
    Patients who have a response of Complete Response (CR), Partial Response (PR), or Stable Disease (SD) by RECIST criteria. To be assigned a status of PR or CR, changes in tumor measurements must be confirmed by repeat assessments that should be performed no less than 4 weeks after the criteria for response are first met. In the case of SD, follow-up measurements must have met the SD criteria at least once after study entry at a minimum interval of 6-8 weeks
  • Maximum tolerated dose of lenalidomide
  • Response rate
  • Safety
  • Immune response
Complete list of historical versions of study NCT00939510 on Archive Site
Number of Patients With Statistically Significant Change in Immune Response From Baseline to End of Study [ Time Frame: every 28 days for first 3 cycles, end of study ]
The change in mean T cell immunohistochemical markers and dendritic cells over time will be evaluated using analysis of variance methods for repeated measures with additional main factors included in the analysis for subset comparisons. The pattern of immune response will be evaluated based upon overall clinical response using these same techniques.
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Lenalidomide and GM-CSF in Treating Patients With Prostate Cancer
Phase I/II Study of Lenalidomide (RevlimidTM ) and GM-CSF in Androgen Independent Prostate Cancer

RATIONALE: Lenalidomide may stop the growth of prostate cancer by blocking blood flow to the tumor. GM-CSF may stimulate the immune system in different ways and stop tumor cells from growing. Giving lenalidomide together with GM-CSF may kill more tumor cells.

PURPOSE: This phase I/II trial is studying the side effects and best dose of lenalidomide when given together with GM-CSF and to see how well it works in treating patients with prostate cancer.


  • Establish the safety of a predetermined target dose or, if the target dose is not tolerable, find the maximum tolerated dose of lenalidomide when administered in combination with sargramostim in patients with androgen-independent prostate cancer.
  • Evaluate the preliminary efficacy of this regimen to ascertain whether additional study of lenalidomide is warranted in patients with androgen-independent prostate cancer.
  • Evaluate the safety of this regimen in these patients.
  • Describe the effects of this regimen on serum cytokines (e.g., TNF-α, bFGF, sIL2R, IL-8, and IL-12) and on serum VEGF levels.
  • Assess the co-stimulatory effects of this regimen on CD4+, CD8+, CD83, and CD86 cells.

OUTLINE: This is a phase I, dose-escalation study of lenalidomide followed by a phase II study.

Patients receive oral lenalidomide on days 1-21 and sargramostim subcutaneously on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, and 26. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Blood samples are collected periodically for correlative biomarker and immunological laboratory studies.

After completion of study therapy, patients are followed up at 30 days and then every 3 months thereafter.

Phase 1
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Prostate Cancer
  • Biological: sargramostim
    All patients will receive GM-CSF at a dose of 250 mcg subcutaneously on Mondays, Wednesdays and Fridays every week. No dose escalation or de-escalations will be made to GM-CSF.
    Other Name: GM-CSF
  • Drug: lenalidomide
    Lenalidomide will be administered at 25 mg/day orally on days 1-21 of a 28-day cycle. Initially 6 patients will be entered at the 25 mg/day level. If 0 or 1 patients have a dose limiting toxicity, then the 25 mg lenalidomide + GM-CSF 250 mcg subcutaneously on Mondays, Wednesdays and Fridays every week will be accepted as the phase II dose.
  • Other: laboratory biomarker analysis
    Prior to the initiation of each cycle of therapy for the first 3 cycles, and at discontinuation from study blood will be collected for assessments of a prostate cancer specific immune response.
Experimental: Lenalidomide (RevlimidTM ) and GM-CSF
  • Biological: sargramostim
  • Drug: lenalidomide
  • Other: laboratory biomarker analysis
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
December 2012
October 2009   (Final data collection date for primary outcome measure)


  • Histologically confirmed adenocarcinoma of the prostate
  • Androgen-independent disease

    • Testosterone ≤ 50 ng/mL

      • Is currently receiving luteinizing hormone-releasing hormone agonists as maintenance or has undergone prior orchiectomy for testosterone suppression
  • Progressive disease, as defined by ≥ 1 of the following:

    • Clinical or radiographic evidence of metastases that have progressed irrespective of PSA changes
    • Asymptomatic (non-opioid requiring) bone-only metastatic disease with a rising PSA on separate measurements ≥ 1 week apart

      • No symptomatic bone metastases
    • Biochemical progression (PSA-only disease), defined as having an absolute PSA value of ≥ 2.0 ng/mL on 3 separate measurements ≥ 2 weeks apart with a PSA doubling time of ≤ 10 months
  • No evidence of CNS (brain or leptomeningeal) metastases or pleural and/or pericardial effusions


  • ECOG performance status of 0-1
  • ANC ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Serum creatinine ≤ 2.0 mg/dL
  • AST < 3 times normal
  • Bilirubin < 1.5 mg/dL
  • PT and PTT normal
  • Calcium normal
  • Fertile patients must use effective contraception during and for ≥ 28 days after completion of study therapy
  • Agrees to abstain from donating blood, semen, or sperm during and for ≥ 28 days after completion of study therapy
  • No pre-existing peripheral neuropathy > grade 1
  • No active unresolved infection
  • No known contraindication to lenalidomide or sargramostim
  • No other malignancies within the past 5 years, except for curatively treated basal cell or squamous cell carcinoma of the skin or stage Ta transitional cell carcinoma of the bladder


  • See Disease Characteristics
  • No prior chemotherapy for metastatic prostate cancer
  • More than 1 year since prior adjuvant and/or neoadjuvant therapy
  • More than 4 weeks since prior flutamide (6 weeks for other antiandrogens)
  • No prior thalidomide or lenalidomide
  • At least 4 weeks since prior surgery or external-beam radiotherapy and recovered
  • At least 6 weeks since prior radiopharmaceutical therapy, including samarium-153 or strontium-89, and recovered
  • No initiation of bisphosphonate therapy within 1 month before and during study therapy

    • Patients on stable doses of bisphosphonates who show subsequent tumor progression may continue to receive bisphosphonates
  • Concurrent daily aspirin for the prevention of thrombotic events required

    • Patients intolerant to aspirin may receive low-dose warfarin as prophylaxis
  • No other concurrent investigational agents
  • No other concurrent anticancer therapy, including radiotherapy or thalidomide
Sexes Eligible for Study: Male
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
P30CA043703 ( U.S. NIH Grant/Contract )
IRB# 8121 ( Other Identifier: Cleveland Clinic IRB )
Not Provided
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Robert Dreicer MD, Case Comprehensive Cancer Center
Robert Dreicer MD
National Cancer Institute (NCI)
Principal Investigator: Robert Dreicer, MD, FACP Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
Case Comprehensive Cancer Center
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP