Completed PHASE2 NCT00020254

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

A Randomized Phase II Study of Either Immunotherapy With a Regimen of Recombinant Pox Viruses That Express PSA/B7.1 Plus Adjuvant GM-CSF and IL2 or Hormone Therapy With Nilutamide in Patients With Hormone Refractory Prostate Cancer and No Radiographic Evidence of Disease

Sponsor: National Cancer Institute (NCI)

Conditions Prostate Cancer

Interventions aldesleukin nilutamide recombinant fowlpox-prostate specific antigen vaccine recombinant vaccinia prostate-specific antigen vaccine recombinant vaccinia-B7.1 vaccine sargramostim

Updated 5 times since 2017 Last updated: Apr 28, 2015 Started: Jun 30, 2000 Primary completion: Oct 31, 2004

A PHASE2 clinical study on Prostate Cancer, this trial is completed. The trial is conducted by National Cancer Institute (NCI) and has accumulated 5 data snapshots since 2000. Oncology trials at this stage typically focus on safety, tolerability, and early efficacy signals.

Status Flow

Change History

5 versions recorded

Sep 2024 — Present [monthly]

Completed PHASE2
Jul 2024 — Sep 2024 [monthly]

Completed PHASE2
Jan 2021 — Jul 2024 [monthly]

Completed PHASE2
Jun 2018 — Jan 2021 [monthly]

Completed PHASE2
Jan 2017 — Jun 2018 [monthly]

Completed PHASE2

First recorded

Jun 2000

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

National Cancer Institute (NCI)

Data source: National Cancer Institute (NCI)

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

• Bethesda, United States