Vaccine Therapy in Treating Patients With Transitional Cell Carcinomas

NCT00070070 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2022-10-12

Study results available
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Summary

RATIONALE: Vaccines made from peptides may make the body build an immune response to kill tumor cells. Biological therapies, such as Bacille Calmette Guerin (BCG) and sargramostim (GM-CSF), use different ways to stimulate the immune system and stop tumor cells from growing. Combining vaccine therapy with biological therapy may kill more tumor cells.

PURPOSE: This phase I trial is studying the side effects of giving vaccine therapy together with BCG and sargramostim in treating patients who have undergone cystectomy for transitional cell carcinomas.

Conditions

  • Transitional Cell Carcinoma

Interventions

BIOLOGICAL

TICE®-strain BCG

BIOLOGICAL

NY-ESO-1 protein

BIOLOGICAL

sargramostim

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH
  • Ludwig Institute for Cancer Research

    lead OTHER

Principal Investigators

  • Dean F. Bajorin, MD · Memorial Sloan Kettering Cancer Center

  • Harry W. Herr, MD · Memorial Sloan Kettering Cancer Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-10-28
Primary Completion
2006-01-03
Completion
2013-09-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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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 NCT00070070 on ClinicalTrials.gov