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BRIEF TITLE: Intravesical Bacillus Calmette-Guerin (BCG) in Combination With ALT-803 in Patients With Non-Muscle Invasive Bladder Cancer

A Study of Intravesical Bacillus Calmette-Guerin (BCG) in Combination With ALT-803 in Patients With Non-Muscle Invasive Bladder Cancer


  • Org Study ID: CA-ALT-803-01-14
  • Secondary ID:
  • NCT ID: NCT02138734
  • NCT Alias:
  • Sponsor: Altor Bioscience Corporation - Industry
  • Source: Altor Bioscience Corporation

Brief Summary

This is a Phase Ib/II, open-label, dose-finding, multicenter study of intravesical BCG plus ALT-803 in Non-muscle invasive bladder cancer.

Detailed Description


The purpose of this study is to evaluate the safety, identify the Maximum Tolerated Dose
(MTD) of ALT-803 and determine the Recommended Dose (RD) level of ALT-803 combined with BCG
in patients who have nonmuscle invasive bladder cancer. The anti-tumor activity of
BCG+ALT-803 will also be assessed. In addition, the study will characterize the molecular,
immunogenicity and pharmacokinetic profile of BCG+ALT-803.

The study includes a dose escalation phase (Phase Ib) and an expansion phase (Phase II). The
dose escalation phase is concluded when the MTD is determined. A dose level (RD) will be
designated for the phase II study. For the noncomparative randomized phase II, patients will
be randomized to two treatment arms: either ALT-803 at the RD level in combination with BCG
(50 mg) or BCG (50 mg) alone.

Overal Status Start Date Phase Study Type
Recruiting Start Date: July 2014 Phase 1/Phase 2 Interventional

Primary Outcomes:

Primary Outcome 1 - Measure: Safety Profile

Primary Outcome 1 - Time Frame: 48 months

Primary Outcome 2 - Measure: MTD Determination and RD Designation

Primary Outcome 2 - Time Frame: 9 months

Condition:

  • Non-muscle Invasive Bladder Cancer

Eligibility

Criteria:
ENTRY CRITERIA:

DISEASE CHARACTERISTICS:

- Histologic confirmation of non-muscle invasive bladder cancer of the transitional cell
carcinoma high-risk subtype.

◦High risk is defined as any high-grade Ta or T1, CIS.

- No evidence of muscle-invasive bladder cancer or regional and/or distant metastasis.

PRIOR/CONCURRENT THERAPY:

- No prior BCG treatment.

- No concurrent use of other investigational agents.

PATIENT CHARACTERISTICS:

Performance Status • ECOG 0, 1, or 2.

Bone Marrow Reserve

- Absolute neutrophil count (AGC/ANC) ≥ 1,000/uL

- Platelets ≥ 100,000/uL

- Hemoglobin ≥ 8g/dL

Renal Function

- Glomerular Filtration Rate (GFR) > 40mL/min or serum creatinine ≤ 1.5 x ULN

Hepatic Function

- Total bilirubin ≤ 2.0 X ULN

- AST, ALT, ALP ≤ 3.0 X ULN

Cardiovascular

- No symptomatic congestive heart failure < 6 months.

- No severe/unstable angina pectoris < 6 months.

- No myocardial infarction < 6 months.

- No NYHA Class > II.

- No marked baseline prolongation of QT/QTc interval.

Pulmonary

• Adequate pulmonary function without any clinical sign of severe pulmonary dysfunction.

Other

- Currently eligible for intravesical BCG therapy.

- Negative serum pregnancy test if female and of childbearing potential.

- No women who are pregnant or nursing.

- Subjects, both females and males, with reproductive potential must agree to use
effective contraceptive measures for the duration of the study.

- No known autoimmune disease other than corrected hypothyroidism (for phase Ib only).

- No prior organ allograft or allogeneic transplantation (for phase Ib only).

- No known positive HIV status.

- No history or evidence of uncontrollable CNS disease.

- No psychiatric illness/social situation that would limit compliance with study
requirements.

- No other illness that in the opinion of the investigator would exclude the patient
from participating in this study.

- Must provide signed informed consent and HIPPA authorization and agree to comply with
all protocol-specified procedures and follow-up evaluations.

- No active systemic infection requiring parenteral antibiotic therapy.

- No ongoing chronic systemic steroid therapy required.

- No concurrent febrile illness, active urinary tract infection, active tuberculosis, a
history of hypotension or anaphylactic reactions.
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Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Official Information

Name: Hing C Wong, PhD

Role: Study Chair

Affiliation: Altor Bioscience Corporation

Locations

Facility Status Contact
University of Alabama at Birmingham
Birmingham, Alabama 35294
United States
Recruiting Ralee' Bishop Bunt
205-934-2272
erikabunt@uabmc.edu
Alaska Clinical Research Center
Anchorage, Alaska 99503
United States
Recruiting Lisa Adams, RMA
907-276-1455
LAdams@akmed.com
UCLA Department of Urology
Los Angeles, California 90024
United States
Recruiting Nazy Zomorodian, NP

nzomorodian@mednet.ucla.edu
University of California, Davis
Sacramento, California 95817
United States
Recruiting Charleen McDaniel
916-734-5173
cmcdaniel@ucdavis.edu
Skyline Sherman Oaks
Sherman Oaks, California 91411
United States
Recruiting Stacey Gomez
310-602-5018
stacey.gomez@skyuro.com
Skyline Urology
Torrance, California 90505
United States
Recruiting Stacey Gomez
310-602-5018
stacey.gomez@skyuro.com
Eastern Connecticut Hematology & Oncology Associates
Norwich, Connecticut 06360
United States
Recruiting Susan Johnson
860-886-8362
drsusanjohnson@cox.net
Moffitt Cancer Center
Tampa, Florida 33612
United States
Recruiting Cortlin Croft
813-745-7559
Cortlin.Croft@Moffitt.org
University of Hawaii Cancer Center
Honolulu, Hawaii 96813
United States
Recruiting Isobel Webster
808-564-5805
iwebster@cc.hawaii.edu
Kansas University Medical Center
Westwood, Kansas 66205
United States
Recruiting Christina Hopkins
913-588-2566
Chopkins2@kumc.edu
Karmanos Cancer Institute
Detroit, Michigan 48201
United States
Recruiting Tamara Dimovski
313-576-9771
dimovskt@karmanos.org
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire 03756
United States
Recruiting Darcie l Findley
603-650-4595
Darcie.L.Findley@hitchcock.org
Winthrop University Hospital
Mineola, New York 11501
United States
Recruiting Kaitlin Kosinski, MS
516-535-1900
KKosinski@Winthrop.org
University Hospitals Cleveland Medical Center
Cleveland, Ohio 44106
United States
Recruiting Cheryl Eitman
216-844-5393
cheryl.eitman2@uhhospitals.org
University of Washington School of Medicine
Seattle, Washington 98109
United States
Recruiting Alexandria z Lahdya
206-598-0853
azlahdya@u.washington.edu