sEphB4-HSA Before Surgery in Treating Patients With Bladder Cancer, Prostate Cancer, or Kidney Cancer

This is an interventional treatment trial for Infiltrating Bladder Urothelial Carcinoma Read More

Inclusion Criteria:

• Written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization for release of personal health information

  • NOTE: HIPAA authorization may be included in the informed consent or obtained separately
• Eastern Cooperative Oncology Group (ECOG) performance status of =< 1 within 14 days prior to being registered for protocol therapy
• Females of childbearing potential and males must be willing to use an effective method of contraception (hormonal or barrier method of birth control; abstinence) from the time consent is signed until 4 weeks after treatment discontinuation

• Females of childbearing potential must have a negative pregnancy test within 7 days prior to being registered for protocol therapy

  • NOTE: Subjects are considered not of child bearing potential if they are surgically sterile (they have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are postmenopausal
• Females must not be breastfeeding
• Cohort A - T2, Transitional cell carcinoma (TCC) muscle invasive bladder cancer, (patients who are cisplatin ineligible, decline neoadjuvant and/or ineligible for neoadjuvant chemotherapy); must have histological proof of T2, muscle-invasive transitional cell carcinoma of the bladder with no evidence of metastatic; patient with any degree of fixation of the pelvic sidewall are not eligible
• Cohort B - Prostate cancer (Gleason 7 or less); must have histological proof of Gleason =< 7 with no evidence of metastatic disease (patient with any degree of extra-prostatic capsule extension are not eligible
• Cohort C - Renal cell carcinoma (> pT1b); must have radiologic suspicion or histological proof of clear cell renal cell carcinoma >= 4 cm with no evidence of metastatic disease; patient with any degree of tumor extension into the renal vein are not eligible; patients must be candidates for contrast-enhanced ultrasound (CEUS) imaging and agree to undergo this additional imaging technique
• Patients must be willing to undergo a biopsy of the cancerous tissue if one was not taken within the previous year, prior to drug initiation if tumor block is not available; biopsy must be done within 14 days of first planned drug dose
• Patients must be willing to undergo a radiologic scan (computed tomography [CT] or magnetic resonance imaging [MRI], depending on organ involved) after last drug dose and prior to minimally-invasive surgery

• Eligible for:

  • Cohort A: Robot-assisted radical cystectomy (RARC) as per the attending urologist
  • Cohort B: Robot-assisted radical Nephrectomy (RARN)/robot-assisted partial nephrectomy (RAPN) as per the attending urologist
  • Cohort C: RAPN as per the attending urologist
• No prior malignancy is allowed except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancers for which the patient has been disease-free for at least 5 years
• No treatment with any investigational agent within 30 days prior to being registered for protocol therapy
• No prior systemic chemotherapy for transitional cell carcinoma of the bladder (prior intravesical therapy is allowed); any other prior chemotherapy must have been completed > 5 years prior to initiation of therapy

• Prior radiation therapy is allowed provided that no radiation therapy was administered to the urinary bladder

  • NOTE: No radiation therapy within 28 days prior to being registered for protocol therapy; laboratory values must be obtained within 14 days prior to being registered for protocol therapy
• Total bilirubin < 2.0 X upper limit of normal (ULN)
• Aspartate aminotransferase (AST) =< 2.5 X ULN
• Alanine aminotransferase (ALT) =< 2.5 X ULN
• Serum Creatinine < 2.5 X ULN
• Absolute neutrophil count (ANC) > 1.5 X K/mm^3
• Platelets > 100 K/mm^3
• International normalized ratio (INR) =< 1.2
• There are currently no known concomitant medications that must be discontinued prior to administration of registration on study and for the duration of sEphB4-HSA
• No clinically significant infections as judged by the treating investigator
• No pleural or pericardial effusion of any grade
• No uncontrolled angina, congestive heart failure or myocardial infraction (MI) within 6 months prior to registration on study
• No diagnosed arrhythmias
• No abnormalities on pre-entry electrocardiogram, obtained within 28 days prior to being registered on study
• No history of diagnosed congenital bleeding disorders (e.g., von Willebrand's disease)
• No abnormalities no history of diagnosed acquired bleeding disorders within one year (e.g., acquired anti-factor VIII antibodies) of registration on protocol therapy
• No abnormalities no history of ongoing or recent (less than or equal to 3 months of registration on protocol therapy) significant gastrointestinal bleeding
• No ongoing anti-coagulation and/or anti-platelet therapies allowed
• Patients with diagnosed uncontrolled hypertension (> 150/90 mmHg) are to be excluded
• Patients with hypertension controlled with medications are allowed
• No evidence of gross hematuria
• No evidence of hydronephrosis
• No evidence of a history of a stroke or myocardial infarction within the last 6 months prior to study enrollment
• No evidence of a history of wound healing complications prior to study enrollment