A Randomized, Multicenter Phase III Trial Evaluating the Efficacy and Safety of BCI-ImmuneActivator Versus Adriamycin in BCG Refractory or Intolerant Patients With Carcinoma in Situ With or Without Resected Superficial Papillary Bladder Cancer
- Compare the efficacy of BCI-ImmuneActivator™ (keyhole limpet hemocyanin) versus
doxorubicin in BCG refractory or intolerant patients with carcinoma in situ with or
without resected superficial papillary bladder cancer.
- Compare the toxicity and safety of these treatments in these patients.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
participating center and prior BCG response (refractory vs intolerant). Patients are
randomized to 1 of 2 treatment arms.
- Arm I: Patients receive a sensitizing dose of keyhole limpet hemocyanin (KLH)
intradermally at week -2 followed by induction KLH IV once weekly at weeks 1-6.
Patients with partial or no response receive IV KLH reinduction therapy once weekly at
weeks 13-18. Patients with complete response receive IV KLH maintenance therapy monthly
at weeks 13, 17, and 21, and then at months 6-12.
- Arm II: Patients receive doxorubicin IV once weekly at weeks 1-6. Patients with
complete response receive maintenance therapy comprising doxorubicin IV at weeks 13,
17, and 21 and months 6-12.
Treatment continues in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 1.5 years, and then every 6 months for 1 year.
(Patient total participation in this study may last as long as 42 months.)
PROJECTED ACCRUAL: A total of 150 patients (75 per treatment arm) will be accrued for this
Allocation: Randomized, Primary Purpose: Treatment
Michael G Hanna Jr., PhD
United States: Federal Government
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