GM-CSF Before Surgery in Treating Patients With Localized Prostate Cancer

NCT00305669 | Completed Phase 1 DMC

• 3 other identifiers: CDR0000455649UCSF-04558UCSF-H40568-25161-02B
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Keywords

adenocarcinoma of the prostate; stage I prostate cancer; stage IIB prostate cancer; stage IIA prostate cancer; stage III prostate cancer

Outcome Measures

Primary Outcomes (1)

• Determine the safety and tolerability of daily neoadjuvant sargramostim (GM-CSF) in patients with localized prostate cancer undergoing radical prostatectomy.

  up to 6 weeks following surgery

Study Arms (1)

GM-CSF before surgery

EXPERIMENTAL

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

Interventions

sargramostim BIOLOGICAL

GM-CSF before surgery

immunohistochemistry staining method OTHER

GM-CSF before surgery

immunological diagnostic method OTHER

GM-CSF before surgery

laboratory biomarker analysis OTHER

GM-CSF before surgery

conventional surgery PROCEDURE

GM-CSF before surgery

neoadjuvant therapy PROCEDURE

GM-CSF before surgery

Eligibility Criteria

• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of California, San Francisco: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

UCSF Helen Diller Family Comprehensive Cancer Center

San Francisco, California, 94115, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

sargramostim; Immunohistochemistry; Neoadjuvant Therapy

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Histocytochemistry; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Histological Techniques; Investigative Techniques; Immunologic Techniques; Combined Modality Therapy; Therapeutics

Study Officials

• Lawrence Fong, MD

  University of California, San Francisco

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2006
• First Posted: March 22, 2006
• Study Start: July 1, 2006
• Primary Completion: January 1, 2011
• Study Completion: June 1, 2014
• Last Updated: June 25, 2014

Record last verified: 2014-06

Locations

US (1)