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

Non-muscle Invasive Bladder Cancer Clinical Trial

— CANON  

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02316171
• Other study ID #: V937-008
• Secondary ID: VLA-0122014-0039
• Status: Completed
• Phase: Phase 1
• Start date: January 16, 2015
• Est. completion date: March 14, 2016

Study information

• Verified date: July 2022
• Source: Viralytics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: March 14, 2016
• Est. primary completion date: March 14, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Non-muscle Invasive Bladder Cancer
• Urinary Bladder Neoplasms

Intervention

Biological:
• CVA21
CAVATAK is a purified preparation of CVA21

Drug:
• Mitomycin C
Chemotherapy

Locations

Country	Name	City	State
United Kingdom	University of Surrey	Guildford

Sponsors (1)

Lead Sponsor	Collaborator
Viralytics

Country where clinical trial is conducted

United Kingdom, 

References & Publications (1)

Annels NE, Mansfield D, Arif M, Ballesteros-Merino C, Simpson GR, Denyer M, Sandhu SS, Melcher AA, Harrington KJ, Davies B, Au G, Grose M, Bagwan I, Fox B, Vile R, Mostafid H, Shafren D, Pandha HS. Phase I Trial of an ICAM-1-Targeted Immunotherapeutic-Cox — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Dose-limiting Toxicities Treatment-related Adverse Events.	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