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 @ 2:16 AM
Ignite Modification Date:
2025-12-25 @ 2:16 AM
NCT ID:
NCT01625260
Eligibility Criteria:
ENTRY CRITERIA:
DISEASE CHARATERISTICS:
* Histologically confirmed high-risk (high grade Ta, T1 or carcinoma in situ, tumor \>4 cm or multi-focal) transitional cell carcinoma s/p TURBT with no remaining resectable disease within 4 weeks of study entry
* Intolerant of treatment with BCG or failure (refractory or relapsing) of at least one prior treatment with BCG
* Refuse or intolerant of a radical cystectomy
* No Evidence of regional and/or distant metastasis
PRIOR/CONCURRENT THERAPY:
* No concurrent radiotherapy, other chemotherapy, or other immunotherapy
* No scheduled radiotherapy, chemotherapy, other immunotherapy, or surgery before the scheduled response evaluation
* Must have recovered from side effects of prior treatments
* No concurrent use of other investigational agents
PATIENT CHARACTERISTICS:
Age
• ≥ 18 years
Performance Status
• ECOG 0, 1, or 2
Bone Marrow Reserve
* Absolute neutrophil count (AGC/ANC) ≥ 1,000/uL
* Platelets ≥ 100,000/uL
* Hemoglobin ≥ 8 g/dL
Renal Function
• Glomerular Filtration Rate (GFR) ≥ 50mL/min
Hepatic Function
* Total bilirubin ≤ 2.0 X ULN
* AST, ALT, ALP ≤ 3.0 X ULN
Cardiovascular
* No congestive heart failure \< 6 months
* No severe/unstable angina pectoris \< 6 months
* No myocardial infarction \< 6 months
* No history of ventricular arrhythmias
* No NYHA Class \> II CHF
* No uncontrollable supraventricular arrhythmias
* No history of a ventricular arrhythmia
* No other clinical signs of severe cardiac dysfunction
* Normal Transthoracic Echocardiogram (TTE) is required for patients who have history of EKG abnormalities, CHF, coronary artery disease or other cardiac disease, or have history of having received adriamycin or doxorubicin
* No patients with a left ventricular ejection fraction (LVEF) of less than 50%
Pulmonary
• Normal clinical assessment of pulmonary function
Other
* Negative serum pregnancy test if female and of childbearing potential
* Women who are not pregnant or nursing
* Subjects, both females and males, with reproductive potential must agree to use effective contraceptive measures for the duration of the study
* No known autoimmune disease other than corrected hypothyroidism
* No known prior organ allograft or allogeneic transplantation
* Not HIV positive
* No active systemic infection requiring parenteral antibiotic therapy
* No ongoing systemic steroid therapy required
* No history or evidence of uncontrollable CNS disease
* No psychiatric illness/social situation
* No other illness that in the opinion of the investigator would exclude the subject from participating in the study
* Must provide informed consent and HIPAA authorization and agree to comply with all protocol-specified procedures and follow-up evaluations
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01625260
Study Brief:
Protocol Section:
NCT01625260