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Gemcitabine Hydrochloride, Cisplatin, and AGS-003-BLD in Treating Patients With Muscle-Invasive Bladder Cancer Undergoing Surgery

NCT02944357 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2017-11-17

No results posted yet for this study

Summary

This pilot clinical trial studies how well gemcitabine hydrochloride, cisplatin, and AGS-003-BLD work in treating patients with bladder cancer that has spread to the muscle and who are undergoing surgery. Drugs used in chemotherapy, such as gemcitabine hydrochloride and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Vaccines made from a person's tumor cells may help the body build an effective immune response to kill tumor cells. Giving gemcitabine hydrochloride, cisplatin, and AGS-003-BLD before surgery may make the tumor smaller and reduce the amount of tissue that needs to be removed by surgery.

Conditions

  • Infiltrating Bladder Urothelial Carcinoma
  • Stage II Bladder Urothelial Carcinoma
  • Stage III Bladder Urothelial Carcinoma
  • Stage IV Bladder Urothelial Carcinoma

Interventions

DRUG

Cisplatin

Given IV

DRUG

Gemcitabine Hydrochloride

Given IV

PROCEDURE

Radical Cystectomy

Undergo cystectomy

BIOLOGICAL

Tumor Cell-Derived Vaccine Therapy

Given AGS-003-BLD ID

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Mayo Clinic

    lead OTHER

Principal Investigators

  • Brian Costello · Mayo Clinic

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-11-30
Primary Completion
2017-09-05
Completion
2017-09-05

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

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 NCT02944357 on ClinicalTrials.gov