Bladder Cancer Clinical Trial
Official title:
A Randomized Phase II Trial of Sequential Chemo-Immunotherapy Versus Immunotherapy Alone in Carcinoma in Situ of the Urinary Bladder
RATIONALE: Biological therapies such as BCG use different ways to stimulate the immune
system and stop tumor cells from growing. Drugs used in chemotherapy use different ways to
stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with
biological therapy may kill more tumor cells. It is not yet known if BCG is more effective
with or without mitomycin.
PURPOSE: Randomized phase II trial to compare the effectiveness of BCG plus mitomycin with
that of BCG alone in treating patients who have bladder cancer.
OBJECTIVES:
- Compare the complete response rate of patients with carcinoma in situ of the bladder
treated with adjuvant intravesical BCG with or without intravesical mitomycin following
transurethral resection.
- Compare the disease-free interval and type of recurrence after complete response in
patients treated with these regimens.
- Compare the side effects of these regimens in these patients.
OUTLINE: This is a randomized, open-label, multicenter study. Patients are randomized to one
of two treatment arms.
Arm I:
- Induction therapy: Patients receive intravesical mitomycin over 1 hour once weekly on
weeks 1-6 and intravesical BCG once weekly on weeks 7-12. Patients with visible lesions
or disease recurrence or progression undergo transurethral resection (TUR) during weeks
16-18 and receive one additional course of intravesical therapy.
- Maintenance therapy:Patients with a complete response after either course of induction
therapy proceed to maintenance therapy comprising intravesical mitomycin once on week 1
and intravesical BCG once weekly on weeks 2 and 3. Maintenance therapy repeats every 6
months through year 3.
Arm II:
- Induction therapy:Patients receive intravesical BCG once weekly on weeks 1-6 and 10-12.
Patients with visible lesions or disease recurrence or progression undergo
transurethral resection (TUR) during weeks 16-18 and receive one additional course of
intravesical therapy.
- Maintenance therapy: Patients with a complete response after either course of induction
therapy receive maintenance therapy comprising intravesical BCG once weekly on weeks
1-3. Maintenance therapy repeats every 6 months through year 3.
Patients are followed every 6 months for 5 years and then annually thereafter.
PROJECTED ACCRUAL: A total of 84-126 patients (42-63 per treatment arm) will be accrued for
this study within 3.5 years.
;
Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment
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