Bladder Cancer Clinical Trial
Official title:
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
Verified date | January 2006 |
Source | National Cancer Institute (NCI) |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Federal Government |
Study type | Interventional |
RATIONALE: Biological therapies use different ways to stimulate the immune system and stop
cancer cells from growing. Drugs used in chemotherapy use different ways to stop tumor cells
from dividing so they stop growing or die. It is not yet known whether keyhole limpet
hemocyanin is more effective than doxorubicin for bladder cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of keyhole limpet
hemocyanin with that of doxorubicin in treating patients who have bladder cancer that has
not responded to BCG or in those patients who cannot tolerate BCG.
Status | Completed |
Enrollment | 0 |
Est. completion date | March 2004 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Randomized, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Intracel Resources, LLC | Frederick | Maryland |
Lead Sponsor | Collaborator |
---|---|
Intracel |
United States,
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