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

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ClinicalTrials.gov Identifier: NCT02316171
Recruitment Status : Completed
First Posted : December 12, 2014
Results First Posted : June 17, 2019
Last Update Posted : July 3, 2019
Sponsor:
Information provided by (Responsible Party):
Viralytics

Brief 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.

Condition or disease Intervention/treatment Phase
Non-muscle Invasive Bladder Cancer Biological: CVA21 Drug: Mitomycin C Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Actual Study Start Date : January 16, 2015
Actual Primary Completion Date : March 14, 2016
Actual Study Completion Date : March 14, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bladder Cancer

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 Name: 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 Name: CAVATAK, Coxsackievirus A21

Drug: Mitomycin C
Chemotherapy




Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02316171


Locations
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United Kingdom
University of Surrey
Guildford, United Kingdom
Sponsors and Collaborators
Viralytics
Investigators
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Principal Investigator: Hardev Pandha Royal Surrey County Hospital NHS Foundation Trust

Additional Information:
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Responsible Party: Viralytics
ClinicalTrials.gov Identifier: NCT02316171     History of Changes
Other Study ID Numbers: V937-008
VLA-012 ( Other Identifier: Viralytics Study ID )
First Posted: December 12, 2014    Key Record Dates
Results First Posted: June 17, 2019
Last Update Posted: July 3, 2019
Last Verified: June 2019
Keywords provided by Viralytics:
Coxsackievirus A21
bladder cancer
CVA21
CAVATAK
Additional relevant MeSH terms:
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Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases
Mitomycins
Mitomycin
Antibiotics, Antineoplastic
Antineoplastic Agents
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors