QUILT-3.032: A Multicenter Clinical Trial of Intravesical Bacillus Calmette-Guerin (BCG) in Combination With ALT-803 in Patients With BCG Unresponsive High Grade Non-Muscle Invasive Bladder Cancer



Status:Recruiting
Conditions:Cancer, Cancer, Bladder Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:2/22/2019
Start Date:June 2, 2017
End Date:September 2020
Contact:Amy Rock, PhD
Email:amyrock@altorbioscience.com
Phone:954-443-8600

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This is a Phase II, open-label, single-arm, multicenter study of intravesical BCG plus
ALT-803 in patients with BCG unresponsive high grade non-muscle invasive bladder cancer
(NMIBC). All patients treated in the study will receive via a urinary catheter in the
bladder, BCG plus ALT-803 weekly for 6 consecutive weeks (initial induction treatment
period). After the first disease assessment, eligible patients will receive either a 3-week
maintenance course or a 6-week re-induction course (second treatment period) at Month 3.
Eligible patients will continue to receive maintenance treatment in the third treatment
period at Months 6, 9, 12, and 18. The study duration is 24 months.


Inclusion Criteria:

- Male or female patients 18 years of age or older

- Histologic confirmation of non-muscle invasive bladder cancer of the transitional cell
carcinoma high-grade subtype (mixed histology tumors allowed if transitional cell
histology is predominant histology).

- Histologically confirmed presence of BCG-unresponsive CIS (with or without Ta or T1
disease) or histologically confirmed presence of BCG-unresponsive high-grade Ta or T1
disease.

- Absence of resectable disease after transurethral resection (TURBT) procedures
(residual carcinoma in situ (CIS) acceptable; patients with T1 tumors must undergo
repeat resection and biopsy [inclusive of muscularis propria] if initial biopsy did
not include muscularis propria). Patients with high-grade Ta and/or T1 disease should
have complete resection before study treatment.

- BCG-unresponsive disease as defined as: (a) Persistent or recurrent CIS (+/- recurrent
Ta/T1 disease) within 12 months of receiving adequate BCG (at least five of six doses
doses of an initial induction course plus either at least two of three doses of
maintenance therapy or at least two of six doses of a second induction course); or (b)
Recurrent high-grade Ta/T1 disease within 6 months of completion of adequate BCG (at
least five of six doses of an initial induction course plus either at least two of
three doses of maintenance therapy or at least two of six doses of a second induction
course); or (c) T1 high-grade disease at the first evaluation following an induction
BCG course alone (at least five of six doses of an initial induction course).

- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2

- Voluntary written informed consent and HIPAA authorization and agree to comply with
all protocol-specified procedures and follow-up evaluations

Exclusion Criteria:

- Recurrence of BCG unresponsive Ta/T1 disease (without presence of CIS) > 6 months
after last BCG instillation or BCG unresponsive CIS > 12 months after last BCG
instillation.

- Life expectancy <2 years

- Any of the following clinical laboratory values at the time of enrollment: (1)
Absolute neutrophil count (ANC) <800/µL or (2) Platelets < 50,000/µL

- Liver function abnormalities as indicated by ongoing hepatic enzyme elevation (AST or
ALT) >2 times upper limit of normal (ULN)

- Renal insufficiency as indicated by a creatinine level >3 times ULN

- History of or evidence of muscle-invasive, locally advanced, metastatic and/or
extravesical bladder cancer; or any other cancer within the past 5 years, except:
adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer,
adequately treated stage I or II cancer from which the patient is currently in
complete remission, or stable prostate cancer (under active surveillance or hormone
control).

- Symptomatic congestive heart failure (CHF), New York Heart Association (NYHA) Class
III or IV heart failure or other clinical signs of severe cardiac dysfunction

- Severe/unstable angina pectoris, or myocardial infarction within 6 months prior to
study entry

- History or evidence of uncontrollable central nervous system (CNS) disease

- Active systemic infection requiring parenteral antibiotic therapy. All prior
infections must have resolved following optimal therapy

- Concurrent febrile illness, active urinary tract infection, active tuberculosis, a
history of hypotension or anaphylactic reactions

- Ongoing chronic systemic steroid therapy required (>10 mg oral prednisone daily or
equivalent)

- Women who are pregnant or nursing. Female patients of childbearing potential must have
a negative pregnancy test and must adhere to using a medically acceptable method of
birth control prior to screening and agree to continue its use during the study and
for 30 days after the last dose of study drug, or be surgically sterilized (e.g.,
hysterectomy or tubal ligation). Women of childbearing potential are defined as any
female who has experienced menarche and who is NOT permanently sterile or
postmenopausal. Postmenopausal is defined as 12 consecutive months with no menses
without an alternative medical cause. Males must agree to use barrier methods of birth
control while on study and for 90 days post last dose of study drug.

- Patients currently receiving investigational or commercial anti-cancer agents or
anti-cancer therapies other than BCG, ALT-803 and supportive care therapies.

- Concurrent use of other investigational agents

- Other illness or condition, including laboratory abnormalities, which in the opinion
of the Investigator would exclude the patient from participating in this study. This
includes, but is not limited to, serious medical conditions or psychiatric illness
likely to interfere with participation in the study.
We found this trial at
31
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Middleburg Heights, Ohio 44130
Principal Investigator: Michael T Barkoukis, MD
Phone: 440-305-8150
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1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
Principal Investigator: Jeffrey Nix, MD
Phone: 205-934-2272
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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1211 Medical Center Dr
Nashville, Tennessee 37232
(615) 322-5000
Principal Investigator: Sam Chang, MD
Phone: 615-343-2120
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
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60 Crittenden Blvd # 70
Rochester, New York 14642
(585) 275-2121
Principal Investigator: Edward Messing, MD
Phone: 585-275-0126
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Anchorage, Alaska 99508
Principal Investigator: William R Clark, MD
Phone: 907-276-1455
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500 S State St
Ann Arbor, Michigan 48109
(734) 764-1817
Principal Investigator: Samuel D Kaffenberger, MD
Phone: 734-232-0753
University of Michigan The University of Michigan was founded in 1817 as one of the...
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Augusta, Georgia 30905
Principal Investigator: Aaron Brothers, MD
Phone: 706-787-5811
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Buffalo, New York 14263
Principal Investigator: Khurshid Guru, MD
Phone: 716-845-1657
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CHapel Hill, North Carolina 27599
Principal Investigator: Hung-Jui Tan, MD
Phone: 919-537-3505
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5841 S Maryland Ave
Chicago, Illinois 60637
(773) 702-1000
Principal Investigator: Gary Steinberg, MD
Phone: 773-702-3080
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Detroit, Michigan 48201
Principal Investigator: Michael L Cher, MD
Phone: 313-576-9771
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El Paso, Texas 79920
Principal Investigator: Daniel Morilla, MD
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Englewood, Colorado 80113
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Phone: 303-733-8848
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1300 Franklin Avenue
Garden City, New York 11530
Principal Investigator: Aaron E Katz, MD
Phone: 516-535-4184
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Honolulu, Hawaii 96813
Principal Investigator: Charles J Rosser, MD
Phone: 808-440-4569
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Inglewood, California 90301
Principal Investigator: Ernest H Agatstein, M.D.
Phone: 310-673-3333
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Kailua, Hawaii 96734
Principal Investigator: Joseph Sterbis, MD
Phone: 808-433-2972
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Los Angeles, California 90024
Principal Investigator: Karim Chamie, MD
Phone: 310-794-3421
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Miami, Florida 33136
Principal Investigator: Mark L Gonzalgo, MD
Phone: 305-243-2177
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New York, New York 10016
Principal Investigator: Jed Kaminetsky, MD
Phone: 212-480-3333
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330 Washington St #220
Norwich, Connecticut 06360
(860) 886-8362
Principal Investigator: Dennis E Slater, MD
Phone: 860-886-8362
Eastern Connecticut Hematology and Oncology Associates In 1985 Dr. Dennis Slater moved from Memorial Sloan-Kettering...
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Omaha, Nebraska 68114
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Phone: 402-399-7893
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1020 Walnut St
Philadelphia, Pennsylvania 19107
(215) 955-6000
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Phone: 215-503-3754
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243 N Rd
Poughkeepsie, New York 12601
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Phone: 845-437-5010
Premier Medical Group of the Hudson Valley Premier Medical Group offers comprehensive, integrated care providing...
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Raleigh, North Carolina 27607
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Richmond, Virginia 23235
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Sherman Oaks, California 91411
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9040 Jackson Ave
Tacoma, Washington 98431
(253) 968-1110
Principal Investigator: Timothy C Brand, MD
Phone: 253-968-2300
Madigan Army Medical Center Located on Joint Base Lewis-McChord, Madigan Army Medical Center comprises a...
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Tampa, Florida 33612
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Toledo, Ohio 43623
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Torrance, California 90505
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