Phase I Study of Intravesical Recombinant Fowlpox - GM-CSF (rF-GM-CSF) and/or Recombinant Fowlpox-TRICOM (rF-TRICOM) in Patients With Bladder Carcinoma Scheduled for Cystectomy
I. 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.
II. Determine the dose-limiting toxic effects of these regimens in these patients.
I. Determine the local and systemic immunologic response in patients treated with these
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 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
In all regimens, patients undergo cystectomy within 4-5 days after the last (4th)
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.
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Maximum tolerated dose (MTD) assessed by Common Toxicity Criteria (CTC)
Up to 39 days
Cancer Institute of New Jersey
United States: Food and Drug Administration
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