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Vaccine Therapy Plus Sargramostim and Interleukin-2 Compared With Nilutamide Alone in Treating Patients With Prostate Cancer

NCT00020254 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2015-04-29

No results posted yet for this study

Summary

RATIONALE: Vaccines made from prostate cancer cells may make the body build an immune response to kill tumor cells. Colony-stimulating factors such as sargramostim may increase the number of immune cells found in bone marrow or peripheral blood. Interleukin-2 may stimulate a person's white blood cells to kill prostate cancer cells. Androgens can stimulate the growth of prostate cancer cells. Hormone therapy using nilutamide may fight prostate cancer by reducing the production of androgens. It is not yet known which treatment regimen is more effective for treating prostate cancer.

PURPOSE: Randomized phase II trial to compare the effectiveness of vaccine therapy plus sargramostim and interleukin-2 with that of nilutamide alone in treating patients who have prostate cancer that has not responded to hormone therapy.

Conditions

Interventions

BIOLOGICAL

aldesleukin

BIOLOGICAL

recombinant fowlpox-prostate specific antigen vaccine

BIOLOGICAL

recombinant vaccinia prostate-specific antigen vaccine

BIOLOGICAL

recombinant vaccinia-B7.1 vaccine

BIOLOGICAL

sargramostim

DRUG

nilutamide

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • Philip M. Arlen, MD · National Cancer Institute (NCI)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2000-06-30
Primary Completion
2004-10-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00020254 on ClinicalTrials.gov