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Neoadjuvant Intravesical Vaccine Therapy in Treating Patients With Bladder Carcinoma Who Are Undergoing Cystectomy
This study has been terminated.
( Slow accrual )

First Received on November 4, 2003.   Last Updated on January 26, 2011   History of Changes
Sponsor: University of Medicine and Dentistry New Jersey
Collaborator: National Cancer Institute (NCI)
Information provided by: University of Medicine and Dentistry New Jersey
ClinicalTrials.gov Identifier: NCT00072137
  Purpose

RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. Placing a vaccine directly into the bladder may cause a stronger immune response and kill more tumor cells.

PURPOSE: This phase I trial is studying the side effects and best dose of intravesical vaccine therapy in treating patients who are undergoing cystectomy for bladder cancer.


Condition Intervention Phase
Bladder Cancer
Biological: recombinant fowlpox GM-CSF vaccine adjuvant
Biological: recombinant fowlpox-TRICOM vaccine
Procedure: conventional surgery
Procedure: neoadjuvant therapy
Phase I

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase I Study of Intravesical Recombinant Fowlpox - GM-CSF (rF-GM-CSF) and/or Recombinant Fowlpox-Tricom (rF-TRICOM) in Patients With Muscle-Invasive Bladder Carcinoma

Resource links provided by NLM:


Further study details as provided by University of Medicine and Dentistry New Jersey:

Enrollment: 21
Study Start Date: October 2003
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

Primary

  • Determine the maximum tolerated dose of neoadjuvant intravesical recombinant fowlpox-TRICOM vaccine and/or recombinant fowlpox-sargramostim vaccine in patients with bladder carcinoma who are scheduled for cystectomy.
  • Determine the dose-limiting toxic effects of these regimens in these patients.

Secondary

  • Determine the local and systemic immunologic response in patients treated with these regimens.

OUTLINE: This is an open-label, dose-escalation study. Patients are alternately assigned to regimens A and B. Once regimens A and B have finished accrual, patients are assigned to regimen C.

  • Regimen A: Patients receive recombinant fowlpox-sargramostim vaccine intravesically on days 1, 8, 15, and 22 for a total of 4 doses.
  • Regimen B: Patients receive recombinant fowlpox-TRICOM vaccine intravesically on days 1, 8, 15, and 22 for a total of 4 doses.
  • Regimen C: Patients receive recombinant fowlpox-TRICOM vaccine combined with recombinant fowlpox-sargramostim vaccine intravesically on days 1, 8, 15, and 22 for a total of 4 doses.

In all regimens, the vaccine(s) is delivered into the bladder by urinary catheter and retained for 2 hours. Treatment continues in the absence of disease progression or unacceptable toxicity.

In all regimens, patients undergo cystectomy within 4-5 days after the last (4th) intravesical instillation.

Cohorts of 3-6 patients in each regimen receive escalating doses of recombinant fowlpox-sargramostim vaccine and/or recombinant fowlpox-TRICOM vaccine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.

Patients are followed every 6 months for 2 years and then annually for 3 years.

PROJECTED ACCRUAL: Approximately 24-42 patients will be accrued for this study within 12-18 months.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed cancer of the urinary bladder, including the following cellular types:

    • Transitional cell carcinoma
    • Adenocarcinoma
    • Squamous cell carcinoma
  • Requires cystectomy as standard therapy and scheduled to undergo surgery
  • Ineligible for neoadjuvant chemotherapy

PATIENT CHARACTERISTICS:

Age

  • Not specified

Performance status

  • ECOG 0-1

Life expectancy

  • At least 6 months

Hematopoietic

  • Absolute neutrophil count greater than 1,500/mm^3
  • Platelet count greater than 75,000/mm^3

Hepatic

  • No history of liver disease and/or history of hepatitis that may suggest persistent disease
  • SGOT less than 2 times normal
  • Bilirubin less than 2.0 mg/dL
  • No presence of liver function abnormalities

Renal

  • Creatinine less than 1.5 mg/dL OR
  • Creatinine clearance greater than 60 mL/min

Cardiovascular

  • No active ischemic heart disease (i.e., New York Heart Association class III or IV cardiac disease)
  • No myocardial infarction within the past 6 months
  • No history of congestive heart failure
  • No history of ventricular arrhythmias or other arrhythmias requiring therapy

Immunologic

  • No history of autoimmune disease, including, but not limited to, the following:

    • Autoimmune neutropenia, thrombocytopenia, or hemolytic anemia
    • Systemic lupus erythematosus
    • Sjögren's syndrome
    • Scleroderma
    • Myasthenia gravis
    • Goodpasture's syndrome
    • Addison's disease
    • Hashimoto's thyroiditis
    • Active Graves' disease
  • No immunodeficiency disorder (e.g., AIDS, SCID, or Wiskott-Aldrich syndrome)
  • No other immunodeficiency disease

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • All patients must abstain from sexual intercourse during and for at least 1 month after final treatment dose
  • No known allergy to eggs
  • No prior exposure to liver toxins
  • No ongoing alcohol consumption or exposure to other liver toxins
  • No active uncontrolled infection
  • No other active malignancy within the past 5 years except superficial squamous cell or basal cell skin cancer or carcinoma in situ of the cervix or prostate
  • No other medical illness that would preclude study participation
  • No uncontrolled psychiatric illness that would preclude study compliance

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • At least 4 weeks since prior immunotherapy
  • At least 2 months since prior intravesical BCG

Chemotherapy

  • No prior neoadjuvant chemotherapy
  • At least 4 weeks since prior systemic chemotherapy
  • At least 2 months since prior intravesical chemotherapy

Endocrine therapy

  • At least 4 weeks since prior systemic steroids
  • No concurrent or imminent steroid therapy

Radiotherapy

  • No prior radiotherapy to the bladder
  • At least 4 weeks since prior radiotherapy

Surgery

  • Not specified

Other

  • Recovered from prior therapy
  • No concurrent acetaminophen
  • No concurrent active antibiotic therapy except as prophylaxis
  • No concurrent immunosuppressive therapy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00072137

Locations
United States, New Jersey
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States, 08903
Sponsors and Collaborators
University of Medicine and Dentistry New Jersey
Investigators
Study Chair: Edmund C. Lattime, PhD Cancer Institute of New Jersey
  More Information

Additional Information:
No publications provided

Responsible Party: Edmund Lattime, PhD, UMDNJ
ClinicalTrials.gov Identifier: NCT00072137     History of Changes
Other Study ID Numbers: CDR0000335473, R21CA074543, P30CA072720, CINJ-3909, NCI-5585
Study First Received: November 4, 2003
Last Updated: January 26, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Medicine and Dentistry New Jersey:
stage II bladder cancer
squamous cell carcinoma of the bladder
adenocarcinoma of the bladder
recurrent bladder cancer
transitional cell carcinoma of the bladder
stage III bladder cancer
stage 0 bladder cancer
stage I bladder cancer

Additional relevant MeSH terms:
Urinary Bladder Neoplasms
Carcinoma
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on February 13, 2012