We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01636882
Recruitment Status : Completed
First Posted : July 10, 2012
Last Update Posted : August 22, 2017
Information provided by (Responsible Party):

Brief Summary:
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 or disease Intervention/treatment Phase
Melanoma Biological: Coxsackievirus A21 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : June 2012
Primary Completion Date : April 2016
Study Completion Date : April 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Melanoma
U.S. FDA Resources

Arm Intervention/treatment
Experimental: CAVATAK extension
Dose of CAVATAK up to 3 x 10⁸ TCID50 for an additional 9 treatments at 3-week intervals
Biological: Coxsackievirus A21

Primary Outcome Measures :
  1. To assess the clinical efficacy of intratumoral (IT) CVA21 when given beyond 18 weeks using immune-related Progression-Free Survival (irPFS) [ Time Frame: Up to 48 weeks ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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

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.

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): NCT01636882

United States, Illinois
Oncology Specialists
Park Ridge, Illinois, United States, 60714
United States, Oregon
Providence Medical Centre
Portland, Oregon, United States, 97213
United States, Texas
Mary Crowley Medical Center
Dallas, Texas, United States, 75230
United States, Utah
Huntsman Cancer Institute
Salt Lake City, Utah, United States, 84112
Sponsors and Collaborators

Responsible Party: Viralytics
ClinicalTrials.gov Identifier: NCT01636882     History of Changes
Other Study ID Numbers: VLA-008
First Posted: July 10, 2012    Key Record Dates
Last Update Posted: August 22, 2017
Last Verified: August 2017

Keywords provided by Viralytics:

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