sEphB4-HSA in Treating Participants With BCG-Unresponsive or Refractory Bladder Cancer

Exclusion Criteria

• •If they are undergoing or have undergone in the past 4 weeks (28 days) any other therapy for their cancer, including radiation therapy and chemotherapy
• •If they have a major systemic infection requiring antibiotics 72 hours or less prior to the first dose of study drug
• •If they have untreated central nervous system (CNS) metastasis; patients whose CNS metastases have been treated by surgery or radiotherapy, who are no longer on corticosteroids, and who are neurologically stable may be enrolled in the dose escalation portion of the trial
• •If they have New York Heart Association (NYHA) class 3 or 4; myocardial infarction, acute coronary syndrome, diabetes mellitus with ketoacidosis or chronic obstructive pulmonary disease (COPD) requiring hospitalization in the preceding 6 months; or any other intercurrent medical condition that contraindicates treatment with sEphB4-HSA or places the patient at undue risk for treatment related complications
• •If they have any other condition, including mental illness or substance abuse, deemed by the investigator to be likely to interfere with a patient?s ability to sign informed consent, cooperate and participate in the study, or interferes with the interpretation of the results
• •If they are pregnant or lactating
• •If they are on any dose of warfarin or are on full dose anticoagulation with other agents, including low molecular weight heparin, antithrombin agents, anti-platelet agents and full dose aspirin within 7 days prior to first dose of study drug; patients on prophylactic doses of low-molecular weight heparin are allowed
• •If they have had any active bleeding in the last =\< 4 weeks or have an otherwise known bleeding diathesis
• •Patients may not be receiving any other investigational agents
• •History of allergic reactions attributed to compounds of similar chemical or biologic composition to agent(s) or other agents used in study
• •Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
• •Patients must not be pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants
• •Evidence of a history of a stroke or myocardial infarction within the last 6 months prior to study enrollment
• •Previous intravesical immunotherapy less than 3 months before study entry; Note: if a patient is eligible for the study but has had intravesical immunotherapy within the past 3 months, they can enroll in the study and initiation of treatment of the drug will be delayed until a minimum of 90 days has passed since the previous treatment
• •Renal and hepatic function values exceeding 2 times the upper normal value
• •Patients who cannot hold instillation for 2 hours
• •Patients who cannot tolerate intravesical dosing or intravesical surgical manipulation