NCT02767921

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

A Pilot Study of Neoadjuvant sEphB4-HSA in Patients With Genitourinary Cancers

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: University of Southern California · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This pilot clinical trial studies the side effects of recombinant EphB4-HSA fusion protein before surgery in treating patients with transitional cell carcinoma of the bladder, prostate cancer, or kidney cancer. Recombinant EphB4-HSA fusion protein may block an enzyme needed for tumor cells to multiply and may also prevent the growth of new blood vessels that bring nutrients to the tumor. Giving recombinant EphB4-HSA fusion protein before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.

Detailed description

PRIMARY OBJECTIVES: I. To determine the feasibility of, and adverse events associated with, treatment with soluble ephrin type-B receptor 4 (sEphB4)-human serum albumin (HSA) (recombinant EphB4-HSA fusion protein) prior to minimally invasive robotic surgery in patients with either muscle-invasive transitional cell carcinoma of the bladder; clear cell renal cell carcinoma (4 cm or greater); or prostate cancer Gleason (7 or under). SECONDARY OBJECTIVES: I. To determine tumor response to neoadjuvant sEphB4 as measured by imaging response and pathologic response. TERTIARY OBJECTIVES: I. To evaluate the expression of ephrin type-B receptor 4 (EphB4) and eph-related receptor tyrosine kinase ligand 5 (EphrinB2) in the archival tumor samples and explore potential associations with outcome. II. To bank specimens for future correlative biomarker studies based on the results of ongoing biomarkers analyses in the phase I of sEphB4-HSA as a single agent. III. To evaluate changes in deoxyribonucleic acid (DNA) methylation of the surgical specimen after being treated with sEphB4-HSA. IV. To evaluate the infiltration of immune cells into the tumor due to administering sEphB4-HSA. V. To evaluate the impact sEphB4-HSA has on vessel density on the tumor tissue. VI. To assess the applicability of using sEphB4-HSA for treating genitourinary cancers. VII. To assess the applicability of using contrast-enhanced ultrasound imaging for determining pathological complete response (pCR) rate. OUTLINE: Patients receive recombinant EphB4-HSA fusion protein intravenously (IV) over 60 minutes once weekly for 3 weeks (3 doses) in the absence of disease progression or unacceptable toxicity. Patients who agree may receive the fourth dose after an additional week as determined by the study medical oncologist. Two to four weeks after the last dose of recombinant EphB4-HSA fusion protein, patients undergo robotic-assisted radical cystectomy or robotic-assisted radical or partial nephrectomy. After completion of study treatment, patients are followed up for 30 days.

Conditions

• Infiltrating Bladder Urothelial Carcinoma
• Recurrent Bladder Carcinoma
• Stage I Prostate Cancer
• Stage I Renal Cell Cancer
• Stage II Bladder Urothelial Carcinoma
• Stage II Renal Cell Cancer
• Stage IIA Prostate Cancer
• Stage IIB Prostate Cancer
• Stage III Prostate Cancer
• Stage III Renal Cell Cancer

Interventions

Type	Name	Description
OTHER	Cytology Specimen Collection Procedure	Correlative studies
OTHER	Laboratory Biomarker Analysis	Correlative studies
PROCEDURE	Radical Cystectomy	Undergo robotic-assisted radical cystectomy
BIOLOGICAL	Recombinant EphB4-HSA Fusion Protein	Given IV
PROCEDURE	Therapeutic Conventional Surgery	Undergo robotic-assisted radical or partial nephrectomy

Timeline

• Start date: 2016-08-02
• Primary completion: 2020-01-28
• Completion: 2021-11-15
• First posted: 2016-05-11
• Last updated: 2021-11-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study