Clinical trial NCT01284205: First Line Comparative Study of EN3348 (MCC) vs BCG in NMIBC
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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Bladder Cancer
Keywords: non-muscle invasive bladder cancer
superficial bladder cancer
Lead sponsor: Bioniche Life Sciences Inc.
Sponsor class: INDUSTRY
First posted: 2011-01-26
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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)

Primary outcomes:
measure: Duration of disease-free survival (time to recurrence, progression or death) in all patients
timeFrame: Baseline, Month 3, 6, 9, 12, 15, 18, 21, and 24
measure: Percent of patients who due to study drug-related AEs experience 2 consecutive treatment delays or discontinue due to drug related AEs
timeFrame: Baseline through 24 months
Secondary outcomes:
measure: Disease-free survival rate at 2 years
timeFrame: Month 24
measure: Frequency, severity, and nature of drug-related AEs
timeFrame: Baseline through 24 Months
measure: Duration of progression-free survival (time to progression or death) in all patients
timeFrame: Baseline, Month 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48 and 60
measure: Frequency, severity, and nature of drug-related SAEs
timeFrame: Baseline through 24 months
measure: Number of treatment delays and their reason
timeFrame: Baseline, Month 3, 6, 9, 12, 15, 18, 21, and 24
measure: Frequency, severity and nature of all AEs
timeFrame: Baseline through 24 months
measure: Number of treatment discontinuations and their reason
timeFrame: Baseline through 24 months
measure: Duration of Survival (time to death from any cause) in all patients
timeFrame: Baseline through month 60
Other outcomes:
Locations:
city: Laguna Hills
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: San Diego
country: United States
state: California
city: Englewood
country: United States
state: Colorado
city: Daytona Beach
country: United States
state: Florida
city: Overland Park
country: United States
state: Kansas
city: Shreveport
country: United States
state: Louisiana
city: Garden City
country: United States
state: New York
city: New York
country: United States
state: New York
city: Pittsburgh
country: United States
state: Pennsylvania
city: Myrtle Beach
country: United States
state: South Carolina
city: McAllen
country: United States
state: Texas
city: Salt Lake City
country: United States
state: Utah
city: Norfolk
country: United States
state: Virginia
Study officials:
References: