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