Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:23 AM
Ignite Modification Date:
2025-12-25 @ 2:23 AM
NCT ID:
NCT00006034
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00006034
Study Brief:
Protocol Section:
NCT00006034