A Phase 1/2 Study of HS-410 in Patients With Non-Muscle Invasive Bladder Cancer After TURBT
Conditions
Bladder Cancer
Conditions: official terms
Urinary Bladder Neoplasms
Conditions: Keywords
TURBT, Bladder, Cancer, GP96, Vaccine, Immunotherapy, Heat Biologics, BCG, Bacillus Calmette-Guerin, Bacillus Calmette-Guérin
Study Type
Interventional
Study Phase
Phase 1/Phase 2
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Intervention
Name: HS-410 Type: Biological
Name: Placebo Type: Biological
Name: BCG Type: Biological
Overall Status
Recruiting
Summary
This is a two-part study. The first stage will test the safety of HS-410, and the second stage will determine whether treatment with bacillus Calmette-Guérin (BCG) in combination with one of two doses of HS-410 increases disease-free survival at 1 year compared to BCG in combination with placebo.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:

- Histologically or cytologically confirmed non-muscle invasive bladder cancer [Ta, T1 or Tis (CIS)] that has been removed by transurethral resection

- Either: (i) high-risk disease, defined as T1 and/or high-grade and/or CIS or (ii) intermediate-risk disease, defined as Ta low-grade with at least 3 of the following 4 risk factors: multiple tumors, tumor size > 3cm, early recurrence (<1 year from previous staging procedure), or recurrence with a frequency of more than once in any 12 month period

- Not have received bacillus Calmette-Guérin (BCG) or have completed previous BCG treatment > 12 months prior to the baseline staging procedure.

- Suitable to receive a 6-week course of BCG in the adjuvant setting within 6 weeks following TURBT. For Phase 1 only: Has previously received 3-6 weekly doses of BCG.

- Adequate laboratory parameters

Exclusion Criteria:

- Human immunodeficiency virus (HIV) infection or immunodeficiency disorders, either primary or acquired

- Infections or intercurrent illness requiring active therapy

- Any condition requiring active steroid or other immunosuppressive therapy

- Other malignancies within the past 12 months except cutaneous basal and/or squamous cell carcinoma(s) or in situ cervical cancer. Patients with concurrent prostate cancer meeting any of the following criteria are eligible: low grade and on active surveillance, after radical prostatectomy with currently undetectable prostate specific antigen (PSA), with detectable PSA but below the definition of biochemical recurrence per the Phoenix criteria and no radiologic evidence of metastatic disease and with PSA doubling time greater than one year, no evidence of metastases and no active therapy.

- Prostate pelvic radiation within the past 12 months

- Significant cardiac impairment

- Current alcohol or chemical abuse, or mental or psychiatric condition precluding protocol compliance

- Pregnant or nursing

- Allergy to soy, egg, or peanut products

- Receiving another investigational agent (30 day wash-out required prior to first dose)

- Neo-adjuvant therapy prior to baseline staging procedures for the current occurrence of non-muscle invasive bladder cancer

- Prior treatment with a cancer vaccine for this indication
Locations
University of California at Los Angeles
Los Angeles, California, United States
Status: Recruiting
Contact: Phuong Nguyen - 310-794-3452 - PVNguyen@mednet.ucla.edu
Skyline Urology
Sherman Oaks, California, United States
Status: Recruiting
Contact: Stacey Gomez - 818-990-5020 - stacey.gomez@skyuro.com
Skyline Urology
Torrance, California, United States
Status: Recruiting
Contact: Edgar Cervantes - 310-602-5018 - edgar.cervantes@skyuro.com
Urology Center of Colorado
Denver, Colorado, United States
Status: Recruiting
Contact: Judy Gibson - 303-421-5783 - jgibson@tucc.com
University of Chicago
Chicago, Illinois, United States
Status: Recruiting
Contact: Alexa Campanile - 773-702-3498 - acampanile@medicine.bsd.uchicago.edu
First Urology
Jeffersonville, Indiana, United States
Status: Recruiting
Contact: Christina Dallas - 812-288-2611 - cdallas@1sturology.com
Horizon Oncology Research
Lafayette, Indiana, United States
Status: Not yet recruiting
Contact: Michelle Hamm - 765-446-5111 - mhamm@horizonbioadvance.com
University of Kansas Cancer Center
Westwood, Kansas, United States
Status: Recruiting
Contact: Rhonda May - 913-588-8292 - rmay2@kumc.edu
Johns Hopkins University
Baltimore, Maryland, United States
Status: Recruiting
Contact: Rehab AbdAlla - 410-955-4042 - rabdall1@jhmi.edu
University of Massachusetts
Worcester, Massachusetts, United States
Status: Recruiting
Contact: Barbara Butler - 508-856-1956 - Barbara.butler@umassmemorial.org
University of Minnesota
Minneapolis, Minnesota, United States
Status: Not yet recruiting
Contact: Therese Perrier - 612-625-3319 - perri084@umn.edu
Washington University School of Medicine
St. Louis, Missouri, United States
Status: Recruiting
Contact: Aleksandra Klim - 314-747-9781 - klima@wudosis.wustl.edu
Montefiore Medical Center
Bronx, New York, United States
Status: Not yet recruiting
Contact: Sandra Goodman - 718-920-8215 - sgoodman@montefiore.org
University of North Carolina Chapel Hill
Chapel Hill, North Carolina, United States
Status: Recruiting
Contact: Dana Mueller - dana_mueller@med.unc.edu
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
Status: Recruiting
Contact: Christine Hubert - 215-955-9954 - christine.hubert@jefferson.edu
Carolina Urologic Research Center
Myrtle Beach, South Carolina, United States
Status: Recruiting
Contact: Michelle Allen - 843-449-1010 - mallen@atlanticurologyclinics.com
Urology Associates, PC
Nashville, Tennessee, United States
Status: Recruiting
Contact: Rick Trotter - 615-250-9268 - CRTrotter@ua-pc.com
Urology of North Texas
Dallas, Texas, United States
Status: Recruiting
Contact: Sharon Reeves - 214-580-1482 - reeves@urologyclinics.com
MD Anderson Cancer Center
Houston, Texas, United States
Status: Recruiting
Contact: Alice Abraham - 713-563-7457 - alicea@mdanderson.org
Urology of Virginia
Virginia Beach, Virginia, United States
Status: Recruiting
Contact: Leigh Ann Brand - 757-452-3464 - lbrand@urologyofva.net
Start Date
December 2013
Completion Date
May 2017
Sponsors
Heat Biologics
Source
Heat Biologics
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page