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Immunologic Effects of GM-CSF (Sargramostim, Leukine®) in Patients With Biochemically-relapsed Prostate Cancer

Phase 2
18 Years
Not Enrolling
Prostate Cancer

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Trial Information

Immunologic Effects of GM-CSF (Sargramostim, Leukine®) in Patients With Biochemically-relapsed Prostate Cancer



- To determine the ability of sargramostim (GM-CSF) to increase the number and activation
of dendritic cells (DC) in patients with biochemically relapsed prostate cancer.


- To determine the effect of administration schedule and hormonal state on
sargramostim-induced DC number and activation in these patients.

- To correlate the effects of sargramostim on DC number and activation with effects on
prostate-specific antigen (PSA) modulation.

- To determine whether sargramostim administration generates antiprostate cancer immune
responses in these patients.

OUTLINE: Patients are stratified according to hormonal status (androgen-dependent vs
androgen-independent). Patients are then randomized to 1 of 2 treatment arms.

- Arm I: Patients receive sargramostim (GM-CSF) subcutaneously (SC) on days 1-14.
Treatment repeats every 28 days for 6 courses in the absence of disease progression or
unacceptable toxicity.

- Arm II: Patients receive GM-CSF SC three times weekly for 4 weeks. Treatment repeats
every 28 days for 6 courses in the absence of disease progression or unacceptable

Patients undergo blood sample collection periodically for correlative studies. Samples are
analyzed for dendritic cell (DC) number by flow cytometry, DC activation by quantitative
real-time polymerase chain reaction (QRT-PCR), and immunity by serological analysis of
recombinant cDNA expression libraries (SEREX).

Inclusion Criteria


- Histologically confirmed adenocarcinoma of the prostate

- Non-metastatic, recurrent systemic disease as manifested by a rising PSA,
defined as ≥ 2 consecutive rises in PSA to be documented over a reference value
(measure 1)

- The first rising PSA (measure 2) should be at taken ≥ 14 days after the
reference value

- A third confirmatory PSA measure is required (second beyond the reference
level) to be greater than the second, and it must be obtained ≥ 14 days
after the second measure

- If this is not the case, a fourth PSA is required to be taken and be
greater than the second measure

- No local-only relapse

- Must have undergone prior definitive therapy for prostate cancer consisting of
external beam radiotherapy, brachytherapy (with or without external beam
radiotherapy), or radical prostatectomy (with or without adjuvant androgen ablation)

- Patients who have not undergone definitive therapy as above or who have
undergone hormonal therapy alone are not eligible

- No evidence of metastases on bone or CT scan


- ECOG performance status 0-1

- Leukocytes ≥ 3,000/μl

- Absolute neutrophil count ≥ 1,500/μl

- Platelets ≥ 100,000/μl

- Total bilirubin normal

- AST and ALT ≤ 2.5 times upper limit of normal (ULN)

- Creatinine ≤ 1.5 times ULN

- No active thrombophlebitis or disseminated intravascular coagulopathy

- No history of pulmonary embolus

- No history of immunodeficiency or autoimmune diseases

- No uncontrolled intercurrent illness, including, but not limited to, ongoing or
active infection, symptomatic congestive heart failure, unstable angina pectoris,
cardiac arrhythmia, or psychiatric illness/social situations that would limit
compliance with study requirements


- See Disease Characteristics

- No prior systemic chemotherapy for any reason

- No concurrent anticoagulation therapy (i.e., therapeutic coumadin)

- Prophylactic anticoagulation (e.g., aspirin) allowed

- No concurrent systemic corticosteroids or other immunosuppressives

- Inhaled or topical steroids allowed

Type of Study:


Study Design:

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

Outcome Measure:

Dendritic cell (DC) activation index post-sargramostim vs pre-sargramostim

Outcome Description:

DC (lin- CD4+) will be purified from peripheral blood using a magnetic cell sorting kit. The number of DC isolated will be expressed per ml of blood. (This will provide an independent method of quantifying total DC population). Activation of the cells separated will be evaluated by assessing the ratio of IL-12(p40) to IL-10 mRNA as quantified by QRT-PCR. A DC activation index will be calculated for each sample by multiplying the number of DC per ml of blood by the ratio of IL-12/IL-10 mRNA expressed.

Outcome Time Frame:

pre-tx and q 2 weeks during tx and post tx

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: Institutional Review Board

Study ID:




Start Date:

October 2005

Completion Date:

July 2010

Related Keywords:

  • Prostate Cancer
  • adenocarcinoma of the prostate
  • recurrent prostate cancer
  • Prostatic Neoplasms



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