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A Study of Intratumoral CAVATAK in Patients With Stage IIIc and Stage IV Malignant Melanoma

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Viralytics
Sponsor:
Information provided by (Responsible Party):
Viralytics
ClinicalTrials.gov Identifier:
NCT01227551
First received: October 20, 2010
Last updated: July 2, 2014
Last verified: July 2014
  Purpose

Approximately 63 patients with stage IIIc or stage IV melanoma will receive 10 intratumoural injections of CAVATAK (Coxsackievirus A21) over 18 weeks.

Disease progression will be monitored by computed tomography (CT) and rated by the RECIST 1.1 assessment criteria. Patients will be monitored for 1 year from their first treatment.

CAVATAK is an oncolytic (cancer killing) virus. Direct injection of the virus into tumors may kill cancer cells by the lytic action of the virus. This action also releases tumor cell debris that may illicit a response by the patients own immune system against the tumour. This study seeks to assess the performance of CAVATAK in both of these actions in late stage melanoma.

Study objectives include:

  • Immune-related Progression-Free Survival
  • Durable Response Rate
  • Progression Free Survival at 6 months
  • Quality of Life

Condition Intervention Phase
Malignant Melanoma
Biological: CAVATAK (Coxsackievirus A21, CVA21)
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
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

Resource links provided by NLM:


Further study details as provided by Viralytics:

Primary Outcome Measures:
  • Immune-related Progression-Free Survival (irPFS) at 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    To assess the clinical efficacy of intratumoral (IT) CVA21 in terms of immune-related Progression-Free Survival (irPFS) at 6 months as monitored via immune-related Response Criteria [irRC] (revised RECIST 1.1).


Secondary Outcome Measures:
  • Durable Response Rate at 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    The clinical efficacy of IT CVA21 is assessed in terms of Durable Response Rate (DRR) at 6 months

  • 6 month Progression-Free Survival, 1 year Survival, Overall Survival [ Time Frame: 6 months and 1 year ] [ Designated as safety issue: No ]
    The clinical efficacy if IT CAVATAK is assessed in terms of Progression-Free Survival at 6 months, 1 - year survival and Overall Survival (OS)

  • Safety of IT CAVATAK administration [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    The safety of IT CAVATAK administration is assessed in terms of adverse events, viral biodistribution and serum antibody responses to CVA21

  • Quality of Life [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    The impact of IT CAVATAK administration on Quality of Life is assessed using the FACT-BRM Questionaire.


Estimated Enrollment: 69
Study Start Date: October 2011
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intratumoral injection Biological: CAVATAK (Coxsackievirus A21, CVA21)
Each patient will receive 10 intratumoral injections of CAVATAK. Each dose will contain up to 3 x 10^8.0 TCID50 virus in a maximum volume of 4 mL.

  Eligibility

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

Inclusion Criteria:

  1. Patient with histologically proven stage IIIc or stage IV melanoma who fails to qualify for curative surgery and who bears one or more tumors that are accessible for direct injection
  2. Patient must have had no more than one previous systemic regimen for management of melanoma; however, adjuvant chemotherapy administered 6 months or longer before entering the trial does not count as a line of treatment
  3. Absence of circulating serum neutralizing antibodies to CVA21 (titer < 1:16)
  4. At least one tumor 0.5 to 10 cm in the longest diameter must be suitable for injection and at least one tumor must be equal to or greater than 1 cm and qualified to be a target lesion for RECIST 1.1 criteria
  5. Patient must have adequate hematologic, hepatic and renal function, defined as:

    • Absolute neutrophil count (ANC) > 1.5 x 10^9/L, platelets > 100 x 10^9/L
    • Bilirubin < 1.5 times the upper limit of normal (ULN), aspartate aminotransferase (AST) < 2.5 x ULN
    • Serum creatinine < 1.5 x ULN; if > 1.5 x ULN, it must be confirmed that creatinine clearance > 30 mL/minute
  6. Serum lactate dehydrogenase (LDH) levels < or = 1.5 x ULN
  7. Male or female age 18 years or older
  8. Performance status (Eastern Cooperative Oncology Group [ECOG]) 0 or 1
  9. Estimated life expectancy of more than 6 months
  10. Recovered from prior therapy with at least 4 weeks since the last exposure to chemotherapy or radiotherapy
  11. Patient is able and willing to provide written informed consent to participate in the study
  12. Fertile males and females must agree to the use of an adequate form of contraception, e.g., condoms for males. A negative pregnancy test is required in female patients of childbearing potential.

Exclusion Criteria:

  1. Mucosal or ocular primary tumors
  2. Bone metastases
  3. Greater than 3 visceral metastases
  4. Any visceral metastases > 10 cm
  5. Serum anti-CVA21 neutralizing titer of > 1:16 at baseline
  6. Presence of any central nervous system (CNS) tumor that has not been stable for at least 3 months off corticosteroids and confirmed by imaging
  7. 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 into a major vessel in the case of necrosis
  8. Only measurable tumor had prior local radiotherapy without subsequent nodule progression
  9. Patient has received chemotherapy within the last 4 weeks prior to first injection
  10. ECOG score greater than 1
  11. Estimated life expectancy of less than 6 months
  12. Pregnancy or breastfeeding
  13. Primary or secondary immunodeficiency, including immunosuppressive disease, and immunosuppressive doses of corticosteroids (e.g., prednisolone > 7.5 mg per day) or other immunosuppressive medications including cyclosporine, azathioprine, interferons within the past 4 weeks prior to screening
  14. Positive serology for human immunodeficiency virus (HIV), hepatitis B or C
  15. Full dose anticoagulation or a history of bleeding diathesis or poorly controlled bleeding in the last month prior to screening
  16. Previous splenectomy
  17. Presence of uncontrolled infection
  18. Presence of unstable neurological disease
  19. Any uncontrolled medical condition that, in the opinion of the investigator, is likely to place the patient at unacceptable risk during the study or reduce his/her ability to complete the study
  20. Participation in another study requiring administration of an investigational drug or biological agent within the last 4 weeks prior to screening
  21. Any other medical or psychological condition that would preclude participation in the study or compromise ability to give informed consent
  22. Participation in any previous melanoma immunotherapy trial within 1 month prior to entry to this trial or any trial of any other investigational agent within the last month prior to entry to this trial
  23. Active infections or serious general medical conditions
  24. Patients with previous malignancies should only be permitted if they have been in a continued state of "no evidence of disease" for at least 5 years with the exception of adequately treated carcinoma in situ of the cervix, ductal carcinoma in situ (DCIS) of the breast, and basal cell/squamous cell skin cancer
  25. Known allergy to treatment medication or its excipients and/or to the contrast medium
  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: NCT01227551

Locations
United States, California
Moores UCSD Cancer Center Completed
La Jolla, California, United States, 92093
St Mary's Medical Center Completed
San Francisco, California, United States, 94117
United States, Florida
Mount Sinai Medical Center Completed
Miami Beach, Florida, United States, 33140
United States, Illinois
Rush University Medical Center Completed
Chicago, Illinois, United States, 60612
Oncology Specialists, SC Completed
Niles, Illinois, United States, 60714
United States, Indiana
Investigative Clinical Research of Indiana Completed
Indianapolis, Indiana, United States, 46260
United States, Missouri
St Louis University Withdrawn
St Louis, Missouri, United States, 63110
United States, New Jersey
Atlantic Melanoma Center Completed
Morristown, New Jersey, United States, 07962
United States, Oregon
Providence Cancer Center Recruiting
Portland, Oregon, United States, 97213
Contact: Brendan Curti, MD    503-215-9948      
Contact: Christopher Fountain, RN    503 215 2691    christopher.fountain@providence.org   
Principal Investigator: Brendan Curti, MD         
United States, Texas
Mary Crowley Cancer Research Centers Completed
Dallas, Texas, United States, 75201
United States, Utah
Huntsman Cancer Institute Recruiting
Salt Lake City, Utah, United States, 84112
Contact: Robert Andtbacka, MD       Robert.Andtbacka@hci.utah.edu   
Contact: Susan Clement    801-587-4767    Susan.Clement@hci.utah.edu   
Principal Investigator: Robert Andtbacka, MD         
Sponsors and Collaborators
Viralytics
Investigators
Principal Investigator: Jose Lutzky, MD Mt Sinai Medical Centre
  More Information

No publications provided

Responsible Party: Viralytics
ClinicalTrials.gov Identifier: NCT01227551     History of Changes
Other Study ID Numbers: VLA-007
Study First Received: October 20, 2010
Last Updated: July 2, 2014
Health Authority: United States: Food and Drug Administration
Australia: Therapeutic Goods Administration

Keywords provided by Viralytics:
Melanoma

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

ClinicalTrials.gov processed this record on November 25, 2014