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

NCT00072137 | Terminated Phase 1

• 6 other identifiers: NCI-2009-00020CDR00003354730503015585U01CA132194P30CA072720
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Maximum tolerated dose (MTD) assessed by Common Toxicity Criteria (CTC)

  Up to 39 days

Study Arms (3)

Arm A (rf-GM-CSF, closed to accrual 10/2004)

EXPERIMENTAL

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.

Biological: Recombinant Fowlpox GM-CSF Vaccine Adjuvant; Procedure: Therapeutic Conventional Surgery; Other: Pharmacological Study; Other: Laboratory Biomarker Analysis

Arm B (rf-TRICOM, closed to accrual 10/2004)

EXPERIMENTAL

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.

Biological: Recombinant Fowlpox-TRICOM Vaccine; Procedure: Therapeutic Conventional Surgery; Other: Pharmacological Study; Other: Laboratory Biomarker Analysis

Arm C (rfTRICOM and rf-GM-CSF)

EXPERIMENTAL

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.

Biological: Recombinant Fowlpox-TRICOM Vaccine; Biological: Recombinant Fowlpox GM-CSF Vaccine Adjuvant; Procedure: Therapeutic Conventional Surgery; Other: Pharmacological Study; Other: Laboratory Biomarker Analysis

Interventions

Recombinant Fowlpox-TRICOM Vaccine BIOLOGICAL

Given intravesically

Also known as: Recombinant Fowlpox-TRICOM, rF-TRICOM (B7.1.iCAM1-LFA3-Fowlpox)

Arm B (rf-TRICOM, closed to accrual 10/2004); Arm C (rfTRICOM and rf-GM-CSF)

Recombinant Fowlpox GM-CSF Vaccine Adjuvant BIOLOGICAL

Given intravesically

Also known as: Fowlpox-Sargramostim, rF-GM-CSF, rF-Sargramostim

Arm A (rf-GM-CSF, closed to accrual 10/2004); Arm C (rfTRICOM and rf-GM-CSF)

Therapeutic Conventional Surgery PROCEDURE

Undergo cystectomy

Arm A (rf-GM-CSF, closed to accrual 10/2004); Arm B (rf-TRICOM, closed to accrual 10/2004); Arm C (rfTRICOM and rf-GM-CSF)

Pharmacological Study OTHER

Correlative studies

Also known as: pharmacological studies

Arm A (rf-GM-CSF, closed to accrual 10/2004); Arm B (rf-TRICOM, closed to accrual 10/2004); Arm C (rfTRICOM and rf-GM-CSF)

Laboratory Biomarker Analysis OTHER

Correlative studies

Arm A (rf-GM-CSF, closed to accrual 10/2004); Arm B (rf-TRICOM, closed to accrual 10/2004); Arm C (rfTRICOM and rf-GM-CSF)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, 08903, United States

Location

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• Robert Weiss

  Rutgers Cancer Institute of New Jersey

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2003
• First Posted: November 6, 2003
• Study Start: October 1, 2003
• Primary Completion: December 1, 2009
• Study Completion: November 1, 2010
• Last Updated: December 23, 2014

Record last verified: 2013-08

Locations

US (1)