Trial record 7 of 8 for:    Open Studies | "Coxsackievirus Infections"

Efficacy and Safety of Intratumoral CAVATAK in Patients With Stage IIIc or IV Malignant Melanoma to Extend Dosing to 48 Weeks

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Viralytics
Sponsor:
Information provided by (Responsible Party):
Viralytics
ClinicalTrials.gov Identifier:
NCT01636882
First received: July 5, 2012
Last updated: January 16, 2014
Last verified: January 2014
  Purpose

This is an extended use study for patients who have received 10 doses of CAVATAK™ in the VLA 007 trial. There may be patients who have benefitted from the study drug and who might benefit from further treatment. In order to accommodate those patients further treatment to complete 48 weeks of CVA21 intratumoral injections will be made available.


Condition Intervention Phase
Melanoma
Biological: Coxsackievirus A21
Phase 2

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 2 Study of the Efficacy and Safety of Intratumoral CAVATAK™ (Coxsackievirus A21, CVA21) in Patients With Stage IIIc and Stage IV Malignant Melanoma to Extend Dosing for up to 48 Weeks Total

Resource links provided by NLM:


Further study details as provided by Viralytics:

Primary Outcome Measures:
  • To assess the clinical efficacy of intratumoral (IT) CVA21 when given beyond 18 weeks using immune-related Progression-Free Survival (irPFS)

Estimated Enrollment: 67
Study Start Date: June 2012
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
  Eligibility

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

Inclusion Criteria:

  • 1. Patients must have reached Week 24 of the core protocol in immune-related complete response (irCR), immune-related partial response (irPR), immune-related stable disease (irSD), or immune-related progressive disease (irPD) (unconfirmed) with evidence of tumor inflammatory reaction.
  • 2. If patient is in irPD (unconfirmed) status, they must not have had a decrease in their Karnofsky Performances Scale (KPS) score > 10 points and to be judged to not have "rapid clinical deterioration" by the investigator since the subject's last tumor measurement leading to irPD assessment.
  • 3. Patients must start treatment in the extension protocol within 8 weeks of their last injection administered in the core protocol.
  • 4. Patient is able and willing to provide written informed consent to participate in the study.
  • 5. Fertile males and females must agree to the use of an adequate form of contraception, e.g., condoms for males.

Exclusion Criteria:

  • 1. Tumors to be injected lying in mucosal regions or close to an airway, major blood vessel or spinal cord that, in the opinion of the Investigators, could cause occlusion or compression in the case of tumor swelling or erosion into a major vessel in the case of necrosis.
  • 2. If lesions are too small to be visualized or palpable for accurate injection.
  • 3. Currently in status of irPD (confirmed) or irPD (unconfirmed) without evidence of tumor inflammatory response, or with rapid clinical deterioration, or with a decrease of 10 points or more on their KPS score since their last assessment before irPD (unconfirmed) assessment.
  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: NCT01636882

Locations
United States, Texas
Mary Crowley Medical Center Recruiting
Dallas, Texas, United States
Contact: John Nemunaitis, MD       jnemunaitis@marycrowley.org   
Principal Investigator: John Nemunaitis, MD         
United States, Utah
Huntsman Cancer Institute Recruiting
Salt Lake City, Utah, United States, 84112
Contact: Robert Andtbacka, MD       Robert.Andtbacka@hci.utah.edu   
Principal Investigator: Robert Andtbacka, MD         
Sponsors and Collaborators
Viralytics
Investigators
Principal Investigator: Jose Lutzky, MD Mount Sinai School of Medicine
  More Information

No publications provided

Responsible Party: Viralytics
ClinicalTrials.gov Identifier: NCT01636882     History of Changes
Other Study ID Numbers: VLA 008
Study First Received: July 5, 2012
Last Updated: January 16, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas

ClinicalTrials.gov processed this record on August 20, 2014