CAVATAK (CVA21) in Non-muscle Invasive Bladder Cancer (VLA-012 CANON) (CANON)

July 20, 2022 updated by: Viralytics

A Phase 1 Study to Evaluate the Safety and Clinical Activity of Intravesicular CAVATAK (Coxsackievirus A21, CVA21) Alone and in Sequential Combination With Low Dose Mitomycin C in Patients With Non-Muscle Invasive Bladder Cancer (VLA-012 CANON)

The study consisted of 2 sequential parts. Part A assessed the safety and tolerability of CAVATAK administered via intravesical instillation in patients with non-muscle invasive bladder cancer scheduled to undergo TUR. Part B assessed the safety and tolerability of CAVATAK administered in sequential combination with low dose Mitomycin C in the same patient population.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This was a Phase I, two-part, open-label, dose-escalation study designed to evaluate CVA21 alone and in sequential combination with low-dose mitomycin C in patients with non-muscle invasive bladder cancer (NMIBC) who were candidates for and were planning to undergo TUR for treatment of their disease. This gave a relatively homogeneous study population and facilitated collection of resected tumour tissue for histological, pharmacodynamics (PD) and pharmacokinetic (PK) analyses.

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Clinical diagnosis of NMIBC based on cystoscopic appearance
  • ECOG 0-2
  • No intravesical therapy within 6 weeks of study entry
  • No prior radiation to the pelvis
  • ANC >1500/mm³; Hb >9.0 g/dL; Platelet >100000/mm³
  • Serum creatinine ≤ 1.5 mg/dL
  • Bilirubin within normal limits; AST ≤ 2.5x upper limit of normal (ULN); ALT ≤ 2.5 x ULN; alkaline phosphatase ≤ 2.5x ULN unless bone metastasis is present in the absence of liver metastasis
  • INR < 1.2; aPPT = 0.8-1.2; PT = 0.9-1.8
  • Candidate for TUR and planning to undergo TUR
  • Negative pregnancy test within 7 days of treatment start
  • Patients of child-bearing potential must agree to use an effective method of birth control

Exclusion Criteria:

  • Prior local or systemic treatments for NMIBC
  • Concurrent treatment with any chemotherapeutic agent
  • Patients not deemed acceptable for general anaesthesia
  • Women who are pregnant or lactating
  • History of vesicoureteric reflux or an indwelling urinary stent
  • Administration of an investigational agent within 3 months of study entry
  • Active cardiac disease
  • Known infection with HIV, hepatitis B or C
  • Active uncontrolled infection

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CVA21
CVA21 was administered by intravesical instillation at one of three (3) ascending dose levels or schedules.
Biological: CVA21
CAVATAK is a purified preparation of CVA21
Other Names:
  • CAVATAK, Coxsackievirus A21
Experimental: CVA21/Mitomycin C
Mitomycin C (MMC) was administered at 10 mg by intravesical instillation on Day 1. Four hours after instillation of MMC, CVA21 was administered by intravesical instillation of one of 2 ascending dose levels or schedules. Subjects received a second instillation of CVA21 alone on Day 2 without pretreatment with MMC.
Biological: CVA21
CAVATAK is a purified preparation of CVA21
Other Names:
  • CAVATAK, Coxsackievirus A21
Drug: Mitomycin C
Chemotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Dose-limiting Toxicities Treatment-related Adverse Events.
Time Frame: 30 days from last dose
Number of Participants with Treatment-emergent adverse events. The events for each cohort of dose of CVA21 only are pooled for the analysis.
30 days from last dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Viralytics

Investigators

  • Principal Investigator: Hardev Pandha, Royal Surrey County Hospital NHS Foundation Trust

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 16, 2015

Primary Completion (Actual)

March 14, 2016

Study Completion (Actual)

March 14, 2016

Study Registration Dates

First Submitted

December 7, 2014

First Submitted That Met QC Criteria

December 9, 2014

First Posted (Estimate)

December 12, 2014

Study Record Updates

Last Update Posted (Actual)

July 27, 2022

Last Update Submitted That Met QC Criteria

July 20, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • V937-008
  • VLA-012 (Other Identifier: Viralytics Study ID)
  • 2014-003938-81 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Non-muscle Invasive Bladder Cancer

Clinical Trials on CVA21

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bosnia & Herzegovina

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe