A Study of Intravesical Bacillus Calmette-Guerin (BCG) in Combination With ALT-803 in Patients With BCG-naive Non-Muscle Invasive Bladder Cancer
Conditions
Non-muscle Invasive Bladder Cancer
Conditions: official terms
Urinary Bladder Neoplasms
Conditions: Keywords
antitumor, BCG, bladder cancer, cancer, immunotherapy, instillation, interleukin-15, intravesical, naive, non-muscle invasive, transitional cell carcinoma
Study Type
Interventional
Study Phase
Phase 1/Phase 2
Study Design
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: ALT-803
Type: Biological
Overall Status
Recruiting
Summary
This is a Phase Ib/II, open-label, dose-finding, multicenter study of intravesical BCG plus ALT-803 in BCG-naive 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 BCG-naive 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 a dose expansion phase (Phase II). The dose escalation phase is concluded when the MTD is determined. A dose level (RD) will be designated for the expansion phase of the study. The expansion phase consists of a noncomparative randomized design of patients receiving ALT-803 at the RD level in combination with BCG or BCG alone.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: ENTRY CRITERIA:

DISEASE CHARACTERISTICS:

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

- Intermediate risk is defined as recurrent Ta/T1 low-grade, multifocal Ta/T1 low-grade.

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

- No evidence of 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) > 59mL/min/1.73m^2

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.

- No prior organ allograft or allogeneic transplantation.

- 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.
Locations
University of Alabama at Birmingham
Birmingham, Alabama, United States
Status: Recruiting
Contact: Ralee' Bishop - 205-934-2272 - erikabishop@uabmc.edu
UCLA Department of Urology
Los Angeles, California, United States
Status: Not yet recruiting
Contact: Nazy Zomorodian, NP - nzomorodian@mednet.ucla.edu
University of Hawaii Cancer Center
Honolulu, Hawaii, United States
Status: Recruiting
Contact: Carol Lieban, RN, BSN, OCN, CCR - clieban@queens.org
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States
Status: Not yet recruiting
Contact: Alyssa McGuire - 603-653-9054 - Alyssa.J.McGuire@hitchcock.org
Start Date
July 2014
Completion Date
October 2018
Sponsors
Altor Bioscience Corporation
Source
Altor Bioscience Corporation
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page