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CAVATAK in Patients With Stage IIIc or IV Malignant Melanoma to Extend Dosing to 48 Weeks (VLA-008 CALM Ext) (CALMext)

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ClinicalTrials.gov Identifier: NCT01636882
Recruitment Status : Completed
First Posted : July 10, 2012
Results First Posted : April 23, 2018
Last Update Posted : April 23, 2018
Sponsor:
Information provided by (Responsible Party):
Viralytics

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: CVA21 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 (VLA-008 CALM Ext)
Actual Study Start Date : July 3, 2012
Actual Primary Completion Date : April 2016
Actual 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: CVA21
Dose of CAVATAK up to 3 x 10⁸ TCID50 for an additional 9 treatments at 3-week intervals
Biological: CVA21



Primary Outcome Measures :
  1. Safety [ Time Frame: 12 months ]
    Participants with Grade 3 or Higher Adverse Events



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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.

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


Locations
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
Viralytics

Additional Information:
Responsible Party: Viralytics
ClinicalTrials.gov Identifier: NCT01636882     History of Changes
Other Study ID Numbers: VLA-008
First Posted: July 10, 2012    Key Record Dates
Results First Posted: April 23, 2018
Last Update Posted: April 23, 2018
Last Verified: April 2018

Keywords provided by Viralytics:
Melanoma
CALM

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