sEphB4-HSA Before Surgery in Treating Patients With Bladder Cancer, Prostate Cancer, or Kidney Cancer
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|ClinicalTrials.gov Identifier: NCT02767921|
Recruitment Status : Recruiting
First Posted : May 11, 2016
Last Update Posted : June 11, 2019
|Condition or disease||Intervention/treatment||Phase|
|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||Other: Cytology Specimen Collection Procedure Other: Laboratory Biomarker Analysis Procedure: Radical Cystectomy Biological: Recombinant EphB4-HSA Fusion Protein Procedure: Therapeutic Conventional Surgery||Phase 1|
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).
I. To determine tumor response to neoadjuvant sEphB4 as measured by imaging response and pathologic response.
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.
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Pilot Study of Neoadjuvant sEphB4-HSA in Patients With Genitourinary Cancers|
|Actual Study Start Date :||August 2, 2016|
|Estimated Primary Completion Date :||August 2, 2020|
|Estimated Study Completion Date :||August 2, 2021|
Experimental: Treatment (recombinant EphB4-HSA fusion protein, surgery)
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 Name: Cytologic Sampling
Other: Laboratory Biomarker Analysis
Procedure: Radical Cystectomy
Undergo robotic-assisted radical cystectomy
Other Name: Complete Cystectomy
Biological: Recombinant EphB4-HSA Fusion Protein
Other Name: sEphB4-HSA
Procedure: Therapeutic Conventional Surgery
Undergo robotic-assisted radical or partial nephrectomy
- 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 [ Time Frame: Up to 30 days after the last dose of sEphB4-HSA ]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.
- Incidence of adverse events graded according to CTCAE version 4 or the Clavien-Dindo classification [ Time Frame: Up to 90 days post-surgery ]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).
- Complete pathologic response defined as no residual evidence of invasive disease at the time of cystectomy or nephrectomy [ Time Frame: At the time of surgery ]Pathologic response rates will be calculated and 90% confidence intervals will be constructed.
- Radiologic response as evaluated by Response Evaluation Criteria in Solid Tumors version 1.1 [ Time Frame: Up to 30 days post-surgery ]Radiologic response rates will be calculated and 90% confidence intervals will be constructed.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02767921
|Contact: Cheryl Kefauver, RN||323-865-0459||Cheryl.Kefauver@med.usc.edu|
|United States, California|
|USC / Norris Comprehensive Cancer Center||Recruiting|
|Los Angeles, California, United States, 90033|
|Contact: Cheryl B. Kefauver, RN 323-865-0459 Cheryl.Kefauver@med.usc.edu|
|Principal Investigator: David I Quinn, MD|
|Principal Investigator:||David I Quinn, MD||University of Southern California|