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Safety and Clinical Activity of CAVATAK™ Alone or With Low Dose Mitomycin C in Non-muscle Invasive Bladder Cancer (CANON)

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ClinicalTrials.gov Identifier: NCT02316171
Recruitment Status : Completed
First Posted : December 12, 2014
Last Update Posted : May 10, 2017
Sponsor:
Information provided by (Responsible Party):
Viralytics

Brief Summary:
The study will consist of 2 sequential parts. Part A is a study of the safety and tolerability of CAVATAK administered via intravesical instillation in patients with non-muscle invasive bladder cancer scheduled to undergo TUR. Part B will evaluate 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: CAVATAK Drug: Mitomycin C Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Non-Randomized
Intervention Model: Single Group 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
Study Start Date : December 2014
Actual Primary Completion Date : July 2016
Actual Study Completion Date : July 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bladder Cancer

Arm Intervention/treatment
Experimental: CAVATAK
CAVATAK will be administered by intravesical instillation up to a total dose of 3 x 10⁸ TCID50
Biological: CAVATAK
CAVATAK is a purified preparation of CVA21
Other Name: CVA21

Mitomycin C
Mitomycin C will be administered at 10 mg by intravesical instillation on day 1.
Biological: CAVATAK
CAVATAK is a purified preparation of CVA21
Other Name: CVA21

Drug: Mitomycin C
Chemotherapy




Primary Outcome Measures :
  1. Safety and tolerability of CAVATAK following intravesical instillation as assessed by incidence of dose-limiting toxicities (DLT). [ Time Frame: 8 days ]
    Evaluate the safety and tolerability of CAVATAK administered via intravesical instillation in patients with NMIBC scheduled to undergo TUR



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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
United Kingdom
University of Surrey
Surrey, United Kingdom
Sponsors and Collaborators
Viralytics

Responsible Party: Viralytics
ClinicalTrials.gov Identifier: NCT02316171     History of Changes
Other Study ID Numbers: VLA012
First Posted: December 12, 2014    Key Record Dates
Last Update Posted: May 10, 2017
Last Verified: May 2017

Additional relevant MeSH terms:
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