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Neoadjuvant Intravesical Vaccine Therapy in Treating Patients With Bladder Carcinoma Who Are Undergoing Cystectomy

NCT00072137 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2014-12-23

No results posted yet for this study

Summary

This phase I trial studies the side effects and best dose of vaccine therapy given directly into the bladder in treating patients who are undergoing surgery to remove all or part of the bladder. Vaccines made from a gene-modified virus may help the body build an effective immune response to kill tumor cells. Giving a vaccine directly into the bladder before surgery may cause a stronger immune response and keep tumor cells from coming back after surgery.

Conditions

  • Bladder Adenocarcinoma
  • Bladder Squamous Cell Carcinoma
  • Bladder Urothelial Carcinoma
  • Recurrent Bladder Carcinoma
  • Stage I Bladder Cancer
  • Stage II Bladder Cancer
  • Stage III Bladder Cancer
  • Stage IV Bladder Cancer

Interventions

BIOLOGICAL

Recombinant Fowlpox-TRICOM Vaccine

Given intravesically

BIOLOGICAL

Recombinant Fowlpox GM-CSF Vaccine Adjuvant

Given intravesically

PROCEDURE

Therapeutic Conventional Surgery

Undergo cystectomy

OTHER

Pharmacological Study

Correlative studies

OTHER

Laboratory Biomarker Analysis

Correlative studies

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • Robert Weiss · Rutgers Cancer Institute of New Jersey

Study Design

Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-10-31
Primary Completion
2009-12-31
Completion
2010-11-30

Countries

  • United States

Study Locations

More Related Trials

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 NCT00072137 on ClinicalTrials.gov