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

NCT02767921 | Terminated Phase 1 DMC FDA Drug

• 3 other identifiers: 0S-15-6NCI-2015-02236P30CA014089
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief 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.

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

Outcome Measures

Primary Outcomes (2)

• Feasibility, defined as the percentage of patients completing at least 3 doses of drug therapy without dose limiting toxicities (DLTs) and who are able to undergo minimally-invasive surgery as planned

  Feasibility is defined for the purpose of this study as \>= 90% of patients completing at least 3 doses of drug therapy without DLTs and are able to undergo minimally-invasive surgery as planned.

  Up to 30 days after the last dose of sEphB4-HSA

• Incidence of adverse events graded according to CTCAE version 4 or the Clavien-Dindo classification

  All observed adverse events and complications will be summarized in terms of type (organ affected or laboratory determination such as absolute neutrophil count), severity, and time of onset. Tables will be created to summarize these adverse events and complications, overall, by disease cohort, and by phase (neoadjuvant, during surgery, within 30 days post-operative, and days 31-90 post-operative).

  Up to 90 days post-surgery

Secondary Outcomes (2)

• Complete pathologic response defined as no residual evidence of invasive disease at the time of cystectomy or nephrectomy

  At the time of surgery

• Radiologic response as evaluated by Response Evaluation Criteria in Solid Tumors version 1.1

  Up to 30 days post-surgery

Study Arms (1)

Treatment (recombinant EphB4-HSA fusion protein, surgery)

EXPERIMENTAL

Patients receive recombinant EphB4-HSA fusion protein 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.

Other: Cytology Specimen Collection Procedure; Other: Laboratory Biomarker Analysis; Procedure: Radical Cystectomy; Biological: Recombinant EphB4-HSA Fusion Protein; Procedure: Therapeutic Conventional Surgery

Interventions

Cytology Specimen Collection Procedure OTHER

Correlative studies

Also known as: Cytologic Sampling

Treatment (recombinant EphB4-HSA fusion protein, surgery)

Laboratory Biomarker Analysis OTHER

Correlative studies

Treatment (recombinant EphB4-HSA fusion protein, surgery)

Radical Cystectomy PROCEDURE

Undergo robotic-assisted radical cystectomy

Also known as: Complete Cystectomy

Treatment (recombinant EphB4-HSA fusion protein, surgery)

Recombinant EphB4-HSA Fusion Protein BIOLOGICAL

Given IV

Also known as: sEphB4-HSA

Treatment (recombinant EphB4-HSA fusion protein, surgery)

Therapeutic Conventional Surgery PROCEDURE

Undergo robotic-assisted radical or partial nephrectomy

Treatment (recombinant EphB4-HSA fusion protein, surgery)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• University of Southern California: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

USC / Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States

Location

MeSH Terms

Conditions

Urinary Bladder Neoplasms; Prostatic Neoplasms; Carcinoma, Renal Cell

Interventions

Cystectomy

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases; Genital Neoplasms, Male; Genital Diseases, Male; Genital Diseases; Prostatic Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Kidney Neoplasms; Kidney Diseases

Intervention Hierarchy (Ancestors)

Urologic Surgical Procedures; Urogenital Surgical Procedures; Surgical Procedures, Operative

Study Officials

• David I Quinn, MD

  University of Southern California

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2016
• First Posted: May 11, 2016
• Study Start: August 2, 2016
• Primary Completion: January 28, 2020
• Study Completion: November 15, 2021
• Last Updated: November 24, 2021

Record last verified: 2021-11

Locations

US (1)