Efficacy and Safety of Intratumoral CAVATAK in Patients With Stage IIIc or IV Malignant Melanoma to Extend Dosing to 48 Weeks
Verified November 2014 by Viralytics
Information provided by (Responsible Party):
First received: July 5, 2012
Last updated: November 26, 2014
Last verified: November 2014
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.
Biological: Coxsackievirus A21
||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||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
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: Yes ]
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||January 2015 (Final data collection date for primary outcome measure)
Experimental: CAVATAK extension
Dose of CAVATAK up to 3 x 10⁸ TCID50 for an additional 9 treatments at 3-week intervals
Biological: Coxsackievirus A21
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- 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.
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For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01636882
|Mary Crowley Medical Center
|Dallas, Texas, United States |
|Contact: John Nemunaitis, MD firstname.lastname@example.org |
|Principal Investigator: John Nemunaitis, MD |
|Huntsman Cancer Institute
|Salt Lake City, Utah, United States, 84112 |
|Contact: Robert Andtbacka, MD Robert.Andtbacka@hci.utah.edu |
|Principal Investigator: Robert Andtbacka, MD |
||Jose Lutzky, MD
||Mount Sinai School of Medicine
No publications provided
ClinicalTrials.gov processed this record on March 26, 2015
History of Changes
|Other Study ID Numbers:
|Study First Received:
||July 5, 2012
||November 26, 2014
||United States: Food and Drug Administration