Clinical trial · Interventional
GM-CSF Before Surgery in Treating Patients With Localized Prostate Cancer
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
NCT00305669CI-TRIAL-00014930completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| conventional surgery | Procedure | — | UNRESOLVED |
| immunohistochemistry staining method | Other | — | UNRESOLVED |
| immunological diagnostic method | Other | — | UNRESOLVED |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| neoadjuvant therapy | Procedure | — | UNRESOLVED |
| sargramostim | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- GM-CSF before surgery
- description
- 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
- interventionNames
- Biological: sargramostim
- Other: immunohistochemistry staining method
- Other: immunological diagnostic method
- Other: laboratory biomarker analysis
- Procedure: conventional surgery
- Procedure: neoadjuvant therapy
Primary outcomes (1)
- measure
- Determine the safety and tolerability of daily neoadjuvant sargramostim (GM-CSF) in patients with localized prostate cancer undergoing radical prostatectomy.
- timeFrame
- up to 6 weeks following surgery
Eligibility
Eligibility (as posted)
- Sex
- Male
Show eligibility criteria text
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 therapiesReferences
Publications (0)
Data not yet available
No reference posted for this study.