This is a Phase Ib/II, open-label, dose-finding, multicenter study of intravesical BCG plus ALT-803 in Non-muscle invasive bladder cancer.
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 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
- 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.
- No prior BCG treatment.
- No concurrent use of other investigational agents.
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
- Glomerular Filtration Rate (GFR) > 40mL/min or serum creatinine ≤ 1.5 x ULN
- Total bilirubin ≤ 2.0 X ULN
- AST, ALT, ALP ≤ 3.0 X ULN
- 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.
• Adequate pulmonary function without any clinical sign of severe pulmonary dysfunction.
- 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
- 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.
Minimum Age: 18 Years
Maximum Age: N/A
Healthy Volunteers: No
Name: Hing C Wong, PhD
Role: Study Chair
Affiliation: Altor Bioscience Corporation
|University of Alabama at Birmingham
Birmingham, Alabama 35294
Ralee' Bishop Bunt
|Alaska Clinical Research Center
Anchorage, Alaska 99503
Lisa Adams, RMA
|UCLA Department of Urology
Los Angeles, California 90024
Nazy Zomorodian, NP
|University of California, Davis
Sacramento, California 95817
|Skyline Sherman Oaks
Sherman Oaks, California 91411
Torrance, California 90505
|Eastern Connecticut Hematology & Oncology Associates
Norwich, Connecticut 06360
|Moffitt Cancer Center
Tampa, Florida 33612
|University of Hawaii Cancer Center
Honolulu, Hawaii 96813
|Kansas University Medical Center
Westwood, Kansas 66205
|Karmanos Cancer Institute
Detroit, Michigan 48201
|Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire 03756
Darcie l Findley
|Winthrop University Hospital
Mineola, New York 11501
Kaitlin Kosinski, MS
|University Hospitals Cleveland Medical Center
Cleveland, Ohio 44106
|University of Washington School of Medicine
Seattle, Washington 98109
Alexandria z Lahdya