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Phase I/II Study of Lenalidomide (RevlimidTM ) and GM-CSF in Androgen Independent Prostate Cancer

Phase 1/Phase 2
18 Years
Not Enrolling
Prostate Cancer

Thank you

Trial Information

Phase I/II Study of Lenalidomide (RevlimidTM ) and GM-CSF in Androgen Independent 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

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.

Inclusion Criteria


- 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


- 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

- 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

Type of Study:


Study Design:

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

Outcome Measure:

Number of Patients With a PSA Response

Outcome Description:

Number of patients with a PSA Response defined as a PSA decline greater or equal to 50% compared with baseline value.

Outcome Time Frame:

reevaluated for response every eight weeks

Safety Issue:


Principal Investigator

Robert Dreicer, MD, FACP

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:

July 2005

Completion Date:

December 2012

Related Keywords:

  • Prostate Cancer
  • adenocarcinoma of the prostate
  • hormone-resistant prostate cancer
  • recurrent prostate cancer
  • stage IV prostate cancer
  • Prostatic Neoplasms



Cleveland Clinic Taussig Institute, Case Comprehensive Cancer Center Cleveland, Ohio  44195