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Activity of TroVax® Alone vs. TroVax® Plus GM-CSF in Patients With Prostate Cancer

NCT00448409 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2016-03-17

No results posted yet for this study

Summary

To evaluate the efficacy and safety of Trovax and GM-CSF in patients with prostate cancer.

Conditions

  • Prostatic Neoplasms

Interventions

BIOLOGICAL

TroVax

11 Intramuscular injection of TroVax® over 45 weeks. A single dose of 5 x 108 pfu/ml, will be given by an intramuscular injection into the deltoid muscle of the upper arm.

DRUG

GM-CSF

168 subcutaneous GM-CSF injections over 45 weeks. Administered every day as a subcutaneous injection at a dose of 250mcg/m2/d (maximum 500 mcg) in weeks 1 and 2 of each 28 day cycle (total of 14 days per cycle with a total of 12 cycles).

Sponsors & Collaborators

  • Oxford BioMedica

    collaborator INDUSTRY

  • The Methodist Hospital Research Institute

    lead OTHER

Principal Investigators

  • Robert J Amato, DO · The Methodist Hospital Research Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-05-31
Primary Completion
2007-04-30
Completion
2007-05-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT00448409 on ClinicalTrials.gov