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

Melanoma Clinical Trial

— CALMext  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01636882
• Other study ID #: V937-006-Ext
• Secondary ID: VLA-008
• Status: Completed
• Phase: Phase 2
• Start date: July 3, 2012
• Est. completion date: April 6, 2016

Study information

• Verified date: June 2019
• Source: Viralytics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: April 6, 2016
• Est. primary completion date: April 6, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Melanoma

Intervention

Biological:
• CVA21

Locations

Country	Name	City	State
United States	Mary Crowley Medical Center	Dallas	Texas
United States	Oncology Specialists	Park Ridge	Illinois
United States	Providence Medical Centre	Portland	Oregon
United States	Huntsman Cancer Institute	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
Viralytics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety	Participants with Grade 3 or Higher Adverse Events	12 months