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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


N/A
N/A
N/A
Open (Enrolling)
Male
Prostate Cancer

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Trial Information

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


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.

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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

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

Outcome Time Frame:

up to 6 weeks following surgery

Safety Issue:

Yes

Principal Investigator

Lawrence Fong, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of California, San Francisco

Authority:

United States: Food and Drug Administration

Study ID:

CDR0000455649

NCT ID:

NCT00305669

Start Date:

July 2006

Completion Date:

June 2014

Related Keywords:

  • Prostate Cancer
  • adenocarcinoma of the prostate
  • stage I prostate cancer
  • stage IIB prostate cancer
  • stage IIA prostate cancer
  • stage III prostate cancer
  • Prostatic Neoplasms

Name

Location

UCSF Helen Diller Family Comprehensive Cancer CenterSan Francisco, California  94115