1B Intravesical Administration of SCH 721015 (Ad-IFNa) in Admixture With SCH 209702 (Syn3) for The Treatment of BCG Refractory Superficial Bladder Cancer

NCT01162785 | Completed Phase 1

• 3 other identifiers: 2009-0938P50CA091846NCI-2010-01769
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this part (Part 1) of this clinical research study is to learn about the safety of giving 2 doses of SCH 72105 (also known as rAd-IFN) directly into the bladder to patients with bladder cancer that has come back. The goal of Part 2 of this study is to learn about the safety of giving 2 more doses of SCH 72105 directly into the bladder of Part 1 participants who had no sign of bladder cancer after Week 12. The level of effectiveness of SCH 72105 will also be studied by measuring the interferon (IFN) levels in the urine.

Conditions

Bladder Cancer

Keywords

BCG Refractory Superficial Bladder Cancer; SCH 721015; Syn3; novel excipient; interferon -alpha-2b; Intravesical; urine IFNa; transitional cell carcinoma of the bladder; superficial non-muscle invasive tumor

Outcome Measures

Primary Outcomes (1)

• Safety + Tolerability of 2 Instillations of Intravesical SCH 721015 in Admixture with Novel Excipient SCH 209702 (Syn3) on Day 1 and Day 4

  Daily urine collection for 14 days

Study Arms (2)

First Dose SCH 721015

EXPERIMENTAL

Part1: 2 Instillations of intravesical SCH 721015 (on Day 1 and 4) at a dose concentration of 3x1011particles/mL given in a 75 mL total volume

Drug: SCH 721015

Second Dose SCH 721015

EXPERIMENTAL

Part 2: Subjects who have a complete response to treatment at Week 12 in Part 1 receive second regimen of intravesical administration of SCH 721015 with Syn3 on same Day 1 and Day 4 regimen at same dose level.

Drug: SCH 721015

Interventions

SCH 721015 DRUG

Intravesical SCH 721015 (on Day 1 and 4) at a dose concentration of 3x1011particles/mL given in a 75 mL total volume. Administered into bladder through a urinary catheter, 75 mL will be instilled, left in the bladder for 1 hour, plus or minus 10 minutes. During the dwell time, subject will be repositioned from left to right, back and abdomen to maximize bladder surface exposure, approximately every 15 minutes.

Also known as: rAd-IFN

First Dose SCH 721015; Second Dose SCH 721015

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects must be willing to give written informed consent and be able to adhere to dose and visit schedules.
• Histologically proven recurrent urothelial carcinoma of the bladder or prostatic urethra, Stage Tis, Ta
• Patients with recurrent T1 disease who do not wish to have cystectomy.
• Subjects must have failed at least two prior courses of BCG with or without recombinant interferon alpha administration or be BCG intolerant. This includes either two six week induction courses of BCG or a 6 week induction course followed by a 3 week mini-induction course of maintenance BCG.
• At least 3 months must have passed since last BCG therapy or intravesical treatment for bladder carcinoma.
• Subjects must be 18 years of age or older
• Life expectancy of at least 3 months
• Adequate performance status (Karnofsky score \>/= 70%)
• Adequate laboratory values. a) Hemoglobin \>/=10 gm/dL. b) White blood cell count (WBC) \>/= 3000/µL. c) Absolute neutrophil count (ANC) \>/= 1500/µL. d) Platelet count \>/=100,000/µL. e) PT \</= 1.5 x upper limit of normal (ULN). f) Activated partial thromboplastin time (aPTT) \</= 1.5 x ULN. g) AST \</=1.5 x ULN. h) ALT \</= 1.5 x ULN. i) Total bilirubin \</= 1.5 x ULN. j) Creatinine \</=1.5 x ULN.
• Female subjects of childbearing potential (Female subjects who are not surgically sterilized, not at least 1 year postmenopausal) must agree to use adequate contraception (e.g. intrauterine device (IUD), condom plus spermicide, diaphragm, or cervical cap plus spermicide) or medical contraception: during the study and for at least 1 month prior to drug administration and for 4 months after treatment. Females who are not currently sexually active must agree and consent to use one of the above-mentioned methods should they become sexually active while participating in the Study.
• Male subjects who are sexually active must agree to use a condom from the beginning of treatment and for 1 month after the last dose

You may not qualify if:

• Pregnant or nursing women
• Suspected hypersensitivity to interferon alpha
• Participation in another clinical trial or use of any investigational drug within 30 days prior to study entry
• Subjects with organ transplants
• Any known preexisting medical condition that could interfere with the subject's participation in and completion of the study such as:
• b. Central nervous system (CNS) trauma or active seizure disorders requiring medication
• c. Significant cardiovascular dysfunction within the past 6 months including symptomatic cardiac ischemia, arrhythmia or congestive heart failure requiring hospitalization or emergency room visit within last 3 months
• d. Poorly controlled diabetes mellitus (HbA1C \>10.0%);
• e. Unstable pulmonary disease requiring hospitalization or emergency room visit within the last 3 months.
• f. Immunologically mediated disease (eg, rheumatoid arthritis, autoimmune hepatitis, immune mediated glomerulonephritis).
• Donation of blood within the preceding 60 days prior to study registration.
• Any other condition that, in the opinion of the investigator, would make the subject unsuitable for enrollment or could interfere with the subject participating in and completing the protocol.
• History of any clinically significant local or systemic infectious disease within 4 weeks prior to initial treatment administration
• Untreated bladder infection
• Positive for hepatitis BsAg or HIV Ab or hepatitis C

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• FKD Therapies Oy of Finland: collaborator
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• University of Texas MD Anderson Cancer Center Website

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• Colin P. Dinney, MD

  M.D. Anderson Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2010
• First Posted: July 15, 2010
• Study Start: April 1, 2011
• Primary Completion: November 1, 2016
• Study Completion: November 1, 2016
• Last Updated: November 28, 2016

Record last verified: 2016-11

Locations

US (1)