Systemic Treatment of Resistant Metastatic Disease (STORM)

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Viralytics
Sponsor:
Information provided by (Responsible Party):
Viralytics
ClinicalTrials.gov Identifier:
NCT02043665
First received: January 19, 2014
Last updated: August 5, 2014
Last verified: August 2014
  Purpose

This study will consist of 2 sequential parts: the first part (VLA009A)is a study of intravenous CVA21 as a single agent for the treatment of 4 different advanced solid tumours; the second part (VLA009B) is a study of intravenous CVA21 in combination with cytotoxic therapy appropriate for the solid tumour selected in the first part. Both parts will be open-label, multi-centre, ascending dose escalation (3+3 design) dose-finding and signal seeking studies.


Condition Intervention Phase
Non-small Cell Lung Cancer
Castrate-resistant Prostate Cancer
Melanoma
Bladder Cancer
Biological: CVA21
Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 1, Dose-finding and Signal-seeking Study of the Safety and Efficacy of Intravenous CAVATAK™ (Coxsackievirus A21, CVA21) Alone and in Combination With Cytotoxic Chemotherapy in Patients With Late Stage Solid Tumours (NSCLC, Castrate-resistant Prostate Cancer, Melanoma, Bladder Cancer).

Resource links provided by NLM:


Further study details as provided by Viralytics:

Primary Outcome Measures:
  • Response rate assessed according to immune-related RECIST 1.1 criteria [ Time Frame: Up to 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 33
Study Start Date: January 2014
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: VLA 009A (First stage), VLA 009B (Second stage) Biological: CVA21

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically-confirmed (1) NSCLC, (2) bladder cancer, (3) castrate-resistant prostate cancer which are metastatic, or (4) stage 3C or stage 4 melanoma.
  • VLA009A: Locally advanced and/or metastatic disease for which curative surgery and/or radiation therapy is not possible and judged not to be a candidate for the current standard of care treatment. VLA009B: locally advanced and/or metastatic disease and judged to be a candidate for the selected cytotoxic therapy to be used in combination with CVA21.
  • Patients with metastatic CRPC must have progressive disease despite surgical castration or ongoing use of gonadotropin-releasing hormone agonists with confirmed castrate levels of testosterone.
  • All subjects in Cohort 3 or Phase 2 dose (P2D) must have a lesion accessible for FNA or core or open biopsy on day 8 of the first treatment cycle.
  • No CVA21 neutralising antibody (≤ 1:16)
  • ECOG score 0-2
  • Life expectancy > 3 months
  • Acceptable haematological, renal and hepatic function
  • Protocol approved by local Research Ethics Committees
  • No chemotherapy, radiation therapy, hormonal treatment of immunotherapy within 28 days of dosing (except active ongoing hormonal therapy for CRPC)
  • Patients must give informed written consent
  • Women of childbearing potential must have negative pregnancy test
  • Measurable or evaluable disease

Exclusion Criteria:

  • Active cardiac disease
  • Women who are pregnant or lactating
  • HIV, hepatitis B or C infections
  • Serious neurologic or psychiatric disease
  • Second primary malignancy within the past 2 years (except non-melanoma skin cancer, in situ carcinoma of the cervix, breast cancer)
  • Active uncontrolled infection
  • Concurrent immunosuppressive therapy and no known immunosuppressive disease other than primary tumour
  • Residual effects from previous therapy that has not resolved to grade 1 or less
  • VLA009B: no medical contraindications to planned cytotoxic therapy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02043665

Contacts
Contact: Hardev Pandha h.pandha@surrey.ac.uk

Locations
United Kingdom
St James University Hospital Recruiting
Leeds, United Kingdom
Contact: Christy Ralph         
Contact: Jennifer Boards    +44 (0)113 206797    Jennifer.Boards@leedsth.nhs.uk   
Sub-Investigator: Christy Ralph         
Institute of Cancer Research Recruiting
London, United Kingdom
Contact: Kevin Harrington         
Contact: Rachel Starkings    +44 (0)207 8082516    Rachel.Starkings@rmh.nhs.uk   
Principal Investigator: Kevin Harrington         
University of Surrey Recruiting
Surrey, United Kingdom
Contact: Hardev Pandha         
Contact: Wendy Hobby    +44 (0)1483 688602    w.hobby@surrey.ac.uk   
Principal Investigator: Hardev Pandha         
Sponsors and Collaborators
Viralytics
  More Information

No publications provided

Responsible Party: Viralytics
ClinicalTrials.gov Identifier: NCT02043665     History of Changes
Other Study ID Numbers: VLA 009, 2012-005256-42
Study First Received: January 19, 2014
Last Updated: August 5, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Prostatic Neoplasms
Carcinoma, Non-Small-Cell Lung
Melanoma
Urinary Bladder Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Lung Diseases
Respiratory Tract Diseases
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas
Urologic Neoplasms
Urinary Bladder Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on September 18, 2014