GM-CSF Before Surgery in Treating Patients With Localized Prostate Cancer
This study is ongoing, but not recruiting participants.
Sponsor:
University of California, San Francisco
Collaborator:
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00305669
First received: March 21, 2006
Last updated: October 9, 2012
Last verified: October 2012
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Prostate Cancer |
Biological: sargramostim Other: immunohistochemistry staining method Other: immunological diagnostic method Other: laboratory biomarker analysis Procedure: conventional surgery Procedure: neoadjuvant therapy |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | 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 |
Resource links provided by NLM:
Further study details as provided by University of California, San Francisco:
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 24 |
| Study Start Date: | July 2006 |
| Estimated Study Completion Date: | June 2013 |
| Primary Completion Date: | January 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 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
|
Biological: sargramostim Other: immunohistochemistry staining method Other: immunological diagnostic method Other: laboratory biomarker analysis Procedure: conventional surgery Procedure: neoadjuvant therapy |
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.
OUTLINE: This is a pilot study. Patients are stratified according to sargramostim (GM-CSF) dose.
Patients receive 1 of 2 dose levels of GM-CSF subcutaneously on days 1-14 or 1-21. Treatment continues in the absence of unacceptable toxicity. Within 3 days after the last dose of GM-CSF, patients undergo radical prostatectomy.
Blood is collected at baseline, day 28 of each course, and at the 4-week follow-up visit and is examined for activated T-cells. Tissue is collected during surgery and assessed for biomarkers and cytokines.
After completion of study treatment, patients are followed at 4 weeks.
PROJECTED ACCRUAL: A total of 28 patients will be accrued for this study.
Eligibility| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00305669
Locations
| United States, California | |
| UCSF Helen Diller Family Comprehensive Cancer Center | |
| San Francisco, California, United States, 94115 | |
Sponsors and Collaborators
University of California, San Francisco
Investigators
| Study Chair: | Lawrence Fong, MD | University of California, San Francisco |
More Information
Additional Information:
No publications provided
| Responsible Party: | University of California, San Francisco |
| ClinicalTrials.gov Identifier: | NCT00305669 History of Changes |
| Other Study ID Numbers: | CDR0000455649, UCSF-04558, UCSF-H40568-25161-02B |
| Study First Received: | March 21, 2006 |
| Last Updated: | October 9, 2012 |
| Health Authority: | United States: Food and Drug Administration United States: Institutional Review Board |
Keywords provided by University of California, San Francisco:
|
adenocarcinoma of the prostate stage I prostate cancer stage IIB prostate cancer stage IIA prostate cancer stage III prostate cancer |
Additional relevant MeSH terms:
|
Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site |
Neoplasms Genital Diseases, Male Prostatic Diseases |
ClinicalTrials.gov processed this record on May 22, 2013