PRIME: Pilot Study Evaluating Percutaneous Vaccination of BCG for Bladder Cancer

NCT02326168 | Completed Early Phase 1 DMC

• 1 other identifier: 140005
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

Approximately 25 subjects will be enrolled and receive a standard WHO adult potency BCG immunization (1cc/50mg live mycobacilli) in the deltoid. Following a wait period after BCG vaccination, patients will then receive standard strength BCG intravesical therapy once a week for a total of 6 weeks. The BCG is instilled and held in the bladder for approximately 2 hours. While the BCG is retained in the bladder the patient should be repositioned every 30 minutes to maximize bladder surface exposure to the agent. Patients will undergo a cystoscopy every 3 months following most recent TURBT. Study duration last approximately 6 months.

Conditions

Bladder Cancer

Outcome Measures

Primary Outcomes (1)

• BCG response

  Percentage of patients with complete response at 3 months following therapy of combined percutaneous vaccination with TICE percutaneous Bacillus Calmette-Guerin (BCG) vaccine combined with standard protocol intravesical induction BCG vaccine for patients with non-muscle invasive transitional cell carcinoma of the bladder.

  3 months after baseline

Secondary Outcomes (1)

• PPD conversion

  3 months from BCG vaccination

Study Arms (1)

non-muscle invasive bladder cancer

EXPERIMENTAL

Every patient meeting eligibility criteria will receive a standard WHO adult potency Bacillus Calmette-Guerin (BCG) immunization (1cc/50mg live mycobacilli) in the right or left deltoid. Following a 19 - 31day wait period after BCG vaccination patients will then receive standard strength BCG intravesical therapy returning once a week for 6 consecutive weeks. Cystoscopy will be performed at 3 and 6 months. Interventions: BCG immunization in deltoid and BCG intravesical therapy once a week for 6 weeks.

Drug: Bacillus Calmette-Guerin (BCG)

Interventions

Bacillus Calmette-Guerin (BCG) DRUG

Intravesical instillation for non-muscle invasive bladder cancer

Also known as: Tice BCG

non-muscle invasive bladder cancer

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The patient must:
• Be 18 years of age or older
• Be able to give informed consent
• Have newly diagnosed or recurrent multi-focal Ta, Large Ta, High Grade Ta, CIS or T1 Bladder Cancer
• Determined by treating urologist to be a good candidate for BCG Induction Therapy
• Have an adequate marrow function (defined as white blood cells greater than 1.5 x 103/µl (or 1,500 cells/mm3) and platelets greater than 150,000 cells/mm3; these results can be within last 60 days from the day of signing informed consent

You may not qualify if:

• The patient cannot:
• Be less than18 years of age
• Unable to give informed consent
• Have a history of muscle invasive bladder cancer
• Be self-reported to be immune-compromised (HIV, chronic immunomodulators, chronic corticosteroids)
• Have a history of tuberculosis and/or received BCG Percutaneous Vaccination
• Pregnant or planning to become pregnant.

Sponsors & Collaborators

• The University of Texas Health Science Center at San Antonio: lead

Study Sites (1)

The University of Texas Health Science Center

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Interventions

BCG Vaccine

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

Intervention Hierarchy (Ancestors)

Tuberculosis Vaccines; Bacterial Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Officials

• Robert S Svatek, MD

  Unv Texas Health Science Center San Antonio

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: December 5, 2014
• First Posted: December 25, 2014
• Study Start: October 1, 2013
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2015
• Last Updated: January 25, 2017

Record last verified: 2017-01

Locations

US (1)