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

• Status: Completed
• Trial end date: 2016-03-14
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Viralytics
• Treatments: Mitomycin; Mitomycins

Criteria

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