First Line Comparative Study of EN3348 (MCC) vs BCG in NMIBC

This study has been withdrawn prior to enrollment.
(This indication is not being pursued at this point in time.)
Sponsor:
Information provided by:
Bioniche Life Sciences Inc.
ClinicalTrials.gov Identifier:
NCT01284205
First received: January 25, 2011
Last updated: August 28, 2014
Last verified: August 2014
  Purpose

The purpose of this study is to compare the safety and efficacy of EN3348 (MCC) versus BCG as first line treatment in patients with non-muscle invasive bladder cancer that are at high risk for recurrence or progression.


Condition Intervention Phase
Bladder Cancer
Biological: Mycobacterial Cell-Wall DNA Complex
Biological: Bacillus Calmette-Guerin
Phase 3

Bioniche Life Sciences Inc. has indicated that access to an investigational treatment associated with this study is available outside the clinical trial.  

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized, Double-blind, Multi-center Study Comparing MCC to BCG as First Line Immunotherapy in Patients With Non-muscle Invasive (Superficial) Bladder Cancer at High Risk of Recurrence or Progression

Resource links provided by NLM:


Further study details as provided by Bioniche Life Sciences Inc.:

Primary Outcome Measures:
  • Duration of disease-free survival (time to recurrence, progression or death) in all patients [ Time Frame: Baseline, Month 3, 6, 9, 12, 15, 18, 21, and 24 ] [ Designated as safety issue: No ]
  • Percent of patients who due to study drug-related AEs experience 2 consecutive treatment delays or discontinue due to drug related AEs [ Time Frame: Baseline through 24 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Disease-free survival rate at 2 years [ Time Frame: Month 24 ] [ Designated as safety issue: No ]
  • Frequency, severity, and nature of drug-related AEs [ Time Frame: Baseline through 24 Months ] [ Designated as safety issue: Yes ]
  • Duration of progression-free survival (time to progression or death) in all patients [ Time Frame: Baseline, Month 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48 and 60 ] [ Designated as safety issue: No ]
  • Frequency, severity, and nature of drug-related SAEs [ Time Frame: Baseline through 24 months ] [ Designated as safety issue: Yes ]
  • Number of treatment delays and their reason [ Time Frame: Baseline, Month 3, 6, 9, 12, 15, 18, 21, and 24 ] [ Designated as safety issue: Yes ]
  • Frequency, severity and nature of all AEs [ Time Frame: Baseline through 24 months ] [ Designated as safety issue: Yes ]
  • Number of treatment discontinuations and their reason [ Time Frame: Baseline through 24 months ] [ Designated as safety issue: Yes ]
  • Duration of Survival (time to death from any cause) in all patients [ Time Frame: Baseline through month 60 ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: January 2010
Estimated Study Completion Date: February 2017
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MCC
Intravesical Administration of Mycobacterial Cell-Wall DNA Complex
Biological: Mycobacterial Cell-Wall DNA Complex
8 mg/50 mL (sterile WFI) Intravesical Administration; one weekly instillation per week for 6 week Induction Phase; three weekly instillations per month at Months 3, 6, 12, 18, and 24 followed by Maintenance Phase.
Active Comparator: BCG
Intravesical Administration of Bacillus Calmette-Guerin
Biological: Bacillus Calmette-Guerin
mg/50 mL (sterile saline) Intravesical Administration; one weekly instillation per week for 6 week Induction Phase; three weekly instillations per month at Months 3, 6, 12, 18, and 24 followed by Maintenance Phase.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • histologically confirmed urothelial carcinoma of the bladder (high grade Ta or T1 papillary lesions, CIS)
  • histologically confirmed diagnosis within 42 days of study treatment
  • life expectancy of greater than 5 years
  • ECOG performance status of 2 or less
  • absence of urothelial carcinoma involving the upper urinary tract or prostatic urethra within 12 months from start of study treatment

Exclusion Criteria:

  • current or previous history of muscle invasive bladder tumors (>T2)
  • current or previous history of lymph node and/or distant metastases from bladder cancer
  • current evidence of squamous cell carcinoma, adenocarcinoma or undifferentiated carcinoma of the bladder
  • current systemic cancer therapy
  • previous immunotherapy for bladder cancer
  • previous intravesical chemotherapy treatment
  • contraindication to use BCG of known tolerance to BCG
  • history of malignancy of any organ system within the past 5 years (with the exception of basal cell or squamous cell carcinoma, stage T1 prostate cancer, carcinoma in situ of the cervix, colon polyps)
  • patients who cannot tolerate intravesical administration or intravesical surgical manipulation (cystoscopy or biopsy)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01284205

Locations
United States, California
Laguna Hills, California, United States
Los Angeles, California, United States
San Diego, California, United States
United States, Colorado
Englewood, Colorado, United States
United States, Florida
Daytona Beach, Florida, United States
United States, Kansas
Overland Park, Kansas, United States
United States, Louisiana
Shreveport, Louisiana, United States
United States, New York
Garden City, New York, United States
New York, New York, United States
United States, Pennsylvania
Pittsburgh, Pennsylvania, United States
United States, South Carolina
Myrtle Beach, South Carolina, United States
United States, Texas
McAllen, Texas, United States
United States, Utah
Salt Lake City, Utah, United States
United States, Virginia
Norfolk, Virginia, United States
Sponsors and Collaborators
Bioniche Life Sciences Inc.
  More Information

No publications provided

Responsible Party: Director of CRND, Endo Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT01284205     History of Changes
Other Study ID Numbers: EN3348-302
Study First Received: January 25, 2011
Last Updated: August 28, 2014
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration
Canada: Ministry of Health
Australia: Therapeutic Goods Administration
New Zealand: Ministry of Health
India: Ministry of Health and Family Welfare
Russia: Ministry of Health
Ukraine: Ministry of Health

Keywords provided by Bioniche Life Sciences Inc.:
non-muscle invasive bladder cancer
superficial bladder cancer

Additional relevant MeSH terms:
Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases
BCG Vaccine
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014