A Pilot Study of Two Dose Schedules of Granulocyte Macrophage Colony-Stimulating Factor (GM-CSF) as Neo-Adjuvant Therapy in Patients With Localized Prostate Cancer
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Enrollment
- 24
- Locations
- 1
- Primary Endpoint
- Determine the safety and tolerability of daily neoadjuvant sargramostim (GM-CSF) in patients with localized prostate cancer undergoing radical prostatectomy.
Study Overview
Brief Summary
RATIONALE: Colony-stimulating factors, such as GM-CSF, may help the body build an effective immune response to kill tumor cells. Giving GM-CSF before surgery may be an effective treatment for localized prostate cancer.
PURPOSE: This clinical trial is studying how well giving GM-CSF before surgery works in treating patients with localized prostate cancer.
Detailed Description
OBJECTIVES:
Primary
- Determine the safety and tolerability of daily neoadjuvant sargramostim (GM-CSF) in patients with localized prostate cancer undergoing radical prostatectomy.
- Determine whether tissue-specific antiprostate cancer immunity is induced by the administration of neoadjuvant GM-CSF in patients with localized prostate cancer prior to radical prostatectomy.
Secondary
- Estimate the baseline antitumor immune response in patients treated with 2 different dose schedules of GM-CSF.
- Determine the magnitude of the difference in immune response between 2 dose schedules of GM-CSF.
- Determine the clinical effects, including prostate-specific antigen (PSA) decline, surgical outcome, surgical complications, and histologic appearance of surgical specimen, of this regimen in these patients.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Sex
- Male
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •DISEASE CHARACTERISTICS:
- •Histologically or cytologically confirmed adenocarcinoma of the prostate
- •No neuroendocrine or small cell features
- •No evidence of metastatic disease
- •Planning radical prostatectomy at least 2 months from now
- •Testosterone level normal
- •PATIENT CHARACTERISTICS:
- •ECOG performance status (PS) 0-1 or Karnofsky PS 70-100%
- •Absolute neutrophil count ≥ 1,500/mm^3
- •Platelet count ≥ 100,000/mm^3
- •Hemoglobin ≥ 8 g/dL
- •AST and ALT ≤ 1.5 times upper limit of normal (ULN)
- •Bilirubin ≤ 1.5 times ULN
- •Creatinine ≤ 1.5 times ULN
- •PT and PTT normal
- •Fertile patients must use effective barrier contraception
- •No history of allergic reaction to compounds of similar chemical or biologic composition to sargramostim (GM-CSF)
- •No ongoing or active bacterial, viral, or fungal infection
- •DLCO > 50% if patient has a history of clinically significant obstructive airway disease
- •No symptomatic congestive heart failure
- •No unstable angina pectoris
- •No cardiac arrhythmia
- •No other active malignancy, defined as cancer for which therapy has been completed and patient is now considered < 30% risk of relapse, except nonmelanoma skin cancer
- •No psychiatric illness or social situation that would preclude study compliance
- •No other uncontrolled illness
- •No underlying medical condition that, in the opinion of the principal investigator, may make the administration of GM-CSF hazardous or obscure the interpretation of adverse events
- •PRIOR CONCURRENT THERAPY:
- •More than 4 weeks since prior major surgery
- •No prior radiotherapy, immunotherapy, chemotherapy, or other investigational therapy for this cancer
- •No prior hormonal therapy including any of the following:
- •Luteinizing-hormone releasing hormone (LHRH) agonists
- •LHRH antagonists
- •Antiandrogens, including any of the following:
- •Bilcalutamide
- •Flutamide
- •Nilutamide
- •5-alpha-reductase inhibitors
- •PC-SPES or other PC-x product
- •Estrogen-containing nutriceuticals
- •No concurrent chemotherapy or radiotherapy
- •No concurrent systemic steroid therapy
- •Concurrent inhaled or topical steroids allowed
- •No other concurrent immunotherapy
- •No other concurrent investigational agent
- •No other concurrent anticancer agents or therapies
Exclusion Criteria
- Not provided
Arms & Interventions
GM-CSF before surgery
GM-CSF dose prior to surgery- Cohort 1-GM-CSF 250mcg/m2 for 2 weeks Cohort 2-GM-CSF 250mcg/m2 for 3 weeks Cohort 3-GM-CSF 250mcg/m2 for 4 weeks Cohort 4-GM-CSF 125mcg/m2 for 4 weeks
Intervention: laboratory biomarker analysis (Other)
GM-CSF before surgery
GM-CSF dose prior to surgery- Cohort 1-GM-CSF 250mcg/m2 for 2 weeks Cohort 2-GM-CSF 250mcg/m2 for 3 weeks Cohort 3-GM-CSF 250mcg/m2 for 4 weeks Cohort 4-GM-CSF 125mcg/m2 for 4 weeks
Intervention: conventional surgery (Procedure)
GM-CSF before surgery
GM-CSF dose prior to surgery- Cohort 1-GM-CSF 250mcg/m2 for 2 weeks Cohort 2-GM-CSF 250mcg/m2 for 3 weeks Cohort 3-GM-CSF 250mcg/m2 for 4 weeks Cohort 4-GM-CSF 125mcg/m2 for 4 weeks
Intervention: neoadjuvant therapy (Procedure)
GM-CSF before surgery
GM-CSF dose prior to surgery- Cohort 1-GM-CSF 250mcg/m2 for 2 weeks Cohort 2-GM-CSF 250mcg/m2 for 3 weeks Cohort 3-GM-CSF 250mcg/m2 for 4 weeks Cohort 4-GM-CSF 125mcg/m2 for 4 weeks
Intervention: immunohistochemistry staining method (Other)
GM-CSF before surgery
GM-CSF dose prior to surgery- Cohort 1-GM-CSF 250mcg/m2 for 2 weeks Cohort 2-GM-CSF 250mcg/m2 for 3 weeks Cohort 3-GM-CSF 250mcg/m2 for 4 weeks Cohort 4-GM-CSF 125mcg/m2 for 4 weeks
Intervention: immunological diagnostic method (Other)
GM-CSF before surgery
GM-CSF dose prior to surgery- Cohort 1-GM-CSF 250mcg/m2 for 2 weeks Cohort 2-GM-CSF 250mcg/m2 for 3 weeks Cohort 3-GM-CSF 250mcg/m2 for 4 weeks Cohort 4-GM-CSF 125mcg/m2 for 4 weeks
Intervention: sargramostim (Biological)
Outcomes
Primary Outcomes
Determine the safety and tolerability of daily neoadjuvant sargramostim (GM-CSF) in patients with localized prostate cancer undergoing radical prostatectomy.
Time Frame: up to 6 weeks following surgery
Secondary Outcomes
No secondary outcomes reported