Keyhole Limpet Hemocyanin Compared With Doxorubicin in Treating Patients With Bladder Cancer
Bladder Cancer
About this trial
This is an interventional treatment trial for Bladder Cancer focused on measuring stage 0 bladder cancer, recurrent bladder cancer
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed carcinoma in situ of the bladder with or without resected superficial papillary tumor Biopsy within 3 months of study with or without positive urinary cytology within 6 weeks of study Cystoscopy within 3 months of study Negative imaging study of the ureters and kidneys within 6 months of study BCG refractory disease Received and failed at least 1 prior induction course consisting of BCG weekly for 6 weeks OR BCG intolerant Unable to receive an adequate course of intravesical BCG due to extreme toxicity Opted against or medically contraindicated to cystectomy PATIENT CHARACTERISTICS: Age 18 and over Performance status ECOG 0-2 OR Karnofsky 60-100% Life expectancy Not specified Hematopoietic WBC greater than 4,000/mm^3 Platelet count greater than 100,000/mm^3 Hemoglobin greater than 11 g/dL Hepatic Bilirubin normal SGOT/SGPT normal Renal Creatinine no greater than 1.5 times upper limit of normal Cardiovascular No severe cardiovascular disease Other No other severe disease No other malignancy within the past 5 years except basal or squamous cell skin cancer or noninvasive cancer of the cervix No evidence of autoimmune disease, known immune deficiency, or immunosuppression Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy See Disease Characteristics No prior keyhole limpet hemocyanin immune activator Chemotherapy No prior doxorubicin At least 3 months since prior mitomycin No other concurrent chemotherapy Endocrine therapy No concurrent steroids Radiotherapy At least 4 months since prior radiotherapy Surgery See Disease Characteristics Other At least 4 weeks since prior intravesical therapy At least 3 months since prior investigational agents No concurrent cytotoxic immunosuppressive agents
Sites / Locations
- Intracel Resources, LLC
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Arm I
Arm II
Patients receive a sensitizing dose of keyhole limpet hemocyanin (KLH) intradermally in week 2 followed by induction KLH IV once weekly in weeks 1-6. Patients with partial or no response receive IV KLH reinduction therapy once weekly in weeks 13-18. Patients with complete response receive IV KLH maintenance therapy monthly in weeks 13, 17, and 21, and then in months 6-12.
Patients receive doxorubicin IV once weekly in weeks 1-6.