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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-10-31

Study Completion Date

2010-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

PRIMARY OBJECTIVES:

I. To assess the safety of intravesical administration of recombinant fowlpox virus encoding three different costimulatory molecules (B7.1, ICAM-1,LFA-3) called TRICOM (-rF-TRICOM) (recombinant fowlpox-TRICOM vaccine) and/or recombinant fowlpox encoding sargramostim (GM-CSF) (rF-GM-CSF) (recombinant fowlpox GM-CSF vaccine adjuvant) in the treatment of patients with carcinoma of the bladder scheduled for cystectomy.

SECONDARY OBJECTIVES:

I. Determine the kinetics of viral infection and gene function as well as host response to intravesical recombinant fowlpox virus in the treatment of bladder cancer.

OUTLINE: This is a dose-escalation study. Patients are alternately assigned to Arms A and B. Once Arms A and B have finished accrual, patients are assigned to Arm C.

ARM A (closed to accrual 10/2004): Patients receive recombinant fowlpox GM-CSF vaccine adjuvant intravesically over 2 hours for 4 weekly doses (on days 1, 8, 15, and 22) with the last dose given 4-6 days prior to cystectomy.

ARM B (closed to accrual 10/2004): Patients receive recombinant fowlpox-TRICOM vaccine intravesically over 2 hours for 4 weekly doses (on days 1, 8, 15, and 22) with the last dose given 4-6 days prior to cystectomy.

ARM C: Patients receive recombinant fowlpox-TRICOM vaccine combined with recombinant fowlpox GM-CSF vaccine adjuvant intravesically over 2 hours for 4 weekly doses (on days 1, 8, 15, and 22) with the last dose given 4-6 days prior to cystectomy.

In all arms, treatment continues in the absence of disease progression or unacceptable toxicity. All patients undergo cystectomy 4-6 days following the last intravesical instillation.

After completion of study treatment, patients are followed up every 6 months for 2 years and then annually for 3 years.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Intervention Type OTHER

Correlative studies

Laboratory Biomarker Analysis

Intervention Type OTHER

Correlative studies

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Recombinant Fowlpox-TRICOM Vaccine

Given intravesically

Intervention Type BIOLOGICAL

Recombinant Fowlpox GM-CSF Vaccine Adjuvant

Given intravesically

Intervention Type BIOLOGICAL

Therapeutic Conventional Surgery

Undergo cystectomy

Intervention Type PROCEDURE

Pharmacological Study

Correlative studies

Intervention Type OTHER

Laboratory Biomarker Analysis

Correlative studies

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Recombinant Fowlpox-TRICOM rF-TRICOM (B7.1.iCAM1-LFA3-Fowlpox) Fowlpox-Sargramostim rF-GM-CSF rF-Sargramostim pharmacological studies

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Patients must have a histologically documented bladder cancer including: transitional cell carcinoma, adenocarcinoma, or squamous cell carcinoma including carcinoma in situ (CIS) requiring cystectomy as a standard therapy for his/her tumor stage and be scheduled for this surgical procedure; patients should not be candidates for neoadjuvant chemotherapy
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
* Estimated life expectancy 6 or more months
* Prior therapy with intravesical Bacille Calmette-Guerin (BCG) and/or chemotherapy is allowed; patient must be at least 2 months beyond the instillation of any prior intravesical agent; patients should not have received systemic chemotherapy, radiation therapy, immunotherapy or systemic doses of steroids for at least 4 weeks prior to starting vaccination and have recovered from all acute toxicities of previous treatment; patients who have received neoadjuvant chemotherapy or radiation therapy to the bladder will be ineligible for this study
* Serum creatinine \< 1.5 mg/dl or a creatinine clearance \> 60 ml/min
* Bilirubin \< 2.0 mg/dl
* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \< 2 x normal range
* Absolute neutrophil count (ANC) \> 1500/mm\^3
* Platelets \> 75000/mm\^3
* Patients must not have known immunodeficiency disorder (acquired immunodeficiency syndrome \[AIDS\], severe combined immunodeficiency \[SCID\], Wiskott-Aldrich syndrome, etc.); study candidates will not be specifically screened for these, unless clinically indicated; if indicated, the referring physician will do the evaluation
* No active/uncontrolled infections
* Pregnant women or nursing mothers are ineligible; women with reproductive potential must have negative pregnancy test and are prohibited from sexual intercourse during this study (while receiving vaccine and at least 1 month following last dose); sexual abstinence (as opposed to contraception only) is necessary; similarly, male patients also must avoid sex for the same period as above
* No uncontrolled psychiatric illness or medical illness that the principal investigator feels will compromise the patient's tolerance of the study treatment
* Patients must be informed of the investigational nature of this study and must give written informed consent in accordance with institutional and federal guidelines; patients who cannot provide informed consent will not be eligible for the study

Exclusion Criteria

* Altered immune-competence:

* Current or imminent steroid therapy or active antibiotic therapy (antibiotics given for prophylaxis are allowed)
* Immune deficiency disease or immunosuppressive therapy in the patient
* Present or history of an autoimmune disease in the patient (e.g. autoimmune neutropenia, thrombocytopenia, or hemolytic anemia; systemic lupus erythematosus, Sjogren syndrome, or scleroderma; myasthenia gravis; Goodpasture syndrome; Addison's disease, Hashimoto's thyroiditis, active Graves' disease, or other diseases which qualify as autoimmune in origin)
* History of allergy to eggs as this vaccine is manufactured in chicken embryo cells
* Patients with any presence of liver function abnormalities, exposure to toxins, ongoing alcohol consumption, history of liver disease and/or history of hepatitis that may suggest persistent disease
* Any concurrent active second malignancy or any malignant tumor within the prior 5 years with the exception of a superficial squamous or basal cell skin carcinoma or in situ carcinoma of the cervix or prostate
* Pregnancy
* Patients with active ischemic heart disease (i.e. class III or IV cardiac disease-New York Heart Association), a recent history of myocardial infarction (within the last 6 months), history of congestive heart failure, ventricular arrhythmias or other arrhythmias requiring therapy

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Robert Weiss

Role: PRINCIPAL_INVESTIGATOR

Rutgers Cancer Institute of New Jersey

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States