Bladder Urothelial Carcinoma Clinical Trial
Official title:
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
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.
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.
;
Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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