An Extended Use Study of Safety and Efficacy of OncoVEXGM-CSF in Melanoma

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
BioVex Limited
ClinicalTrials.gov Identifier:
NCT01368276
First received: April 20, 2011
Last updated: June 15, 2011
Last verified: June 2011
  Purpose

The purpose of this study is to learn about the safety and the risks of using OncoVEXGM-CSF in patients who already received treatment with OncoVEXGM-CSF in study 005/05, and to see if extended treatment with OncoVEXGM-CSF can destroy melanoma tumors. This study may provide information on the usefulness of OncoVEXGM-CSF as a future treatment for melanoma.


Condition Intervention Phase
Melanoma
Biological: OncoVEXGM-CSF
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Extension Protocol to Evaluate the Efficacy and Safety of Extended Use Treatment With OncoVEXGM-CSF for Eligible Melanoma Patients Participating in Study 005/05

Resource links provided by NLM:


Further study details as provided by BioVex Limited:

Primary Outcome Measures:
  • To evaluate safety [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Safety assessments will be based on adverse events, laboratory data, concomitant medications, the results of physical examinations and vital signs.


Secondary Outcome Measures:
  • To evaluate objective tumor response rate [Complete Response (CR) and Partial Response (PR) using protocol guideline] [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    CT (Computed Tomography) scans every 12 weeks

  • To evaluate durable response rate, defined as the rate of objective response [Complete Response(CR) or Partial Response (PR)] lasting continuously for 6 or more months [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    CT (Computed Tomography) scans every 12 weeks


Estimated Enrollment: 25
Study Start Date: October 2010
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: OncoVEXGM-CSF Biological: OncoVEXGM-CSF
Up to 4 mL of 10^8 pfu/mL/per injection

  Eligibility

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

Inclusion Criteria:

  1. Previously participated and was randomized to the OncoVEXGM-CSF arm in protocol 005/05 and:

    1. received the maximum number of OncoVEXGM-CSF treatment injections allowable for that patient on study 005/05, or
    2. new injectable lesion(s) appeared after previous resolution of all injectable disease while on study 005/05.
  2. In the opinion of the investigator and the sponsor's medical monitor further treatment is warranted [e.g., those patients who do not have clinically relevant progressive disease (PDr)].
  3. Performance status (Eastern Co-Operative Oncology Group, ECOG) 0 or 1.
  4. Injectable disease (i.e. suitable for direct injection or through the use of ultrasound guidance) defined as at least 1 injectable cutaneous, subcutaneous or nodal melanoma lesion. There is no minimum size for injection.

Exclusion Criteria:

  1. Prior CTCAE (Common Terminology Criteria for Adverse Events) grade 3 or 4 toxicity related to OncoVEXGM-CSF of any organ system (with the exception of injection site reactions, fever and vomiting).
  2. History of Grade 3 fatigue lasting > 1 week while on OncoVEXGM-CSF treatment.
  3. History of Grade 3 arthralgia/myalgias while on OncoVEXGM-CSF treatment.
  4. History of ≥ Grade 2 autoimmune reactions, allergic reactions or urticaria or other OncoVEXGM-CSF related non-hematological toxicities while on OncoVEXGM-CSF treatment that required a dose delay or discontinuation of OncoVEXGM-CSF therapy.
  5. PDr while participating in study 005/05
  6. Patient requested to be withdrawn from study 005/05 or was unable to comply with the demands of the 005/05 trial.
  7. At the discretion of the investigator, patient was withdrawn from the 005/05 trial.
  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: NCT01368276

Locations
United States, Illinois
Rush University Medical Center
Chicago, Illinois, United States, 60612
United States, Indiana
Indiana University
Indianapolis, Indiana, United States, 46202
United States, Iowa
University of Iowa Hospitals & Clinics
Iowa City, Iowa, United States, 52242
United States, Kentucky
James Graham Brown Cancer Center
Louisville, Kentucky, United States, 40202
United States, Minnesota
Hubert H Humphrey Cancer Center
Robbinsdale, Minnesota, United States, 55422
United States, North Carolina
University of North Carolina At Chapel Hill School of Medicine
Chapel Hill, North Carolina, United States, 27599
United States, Texas
Mary Crowley Medical Research Center
Dallas, Texas, United States, 75246
United States, Utah
Huntsman Cancer Institute
Salt Lake City, Utah, United States, 84112
United States, Virginia
Oncology and Hematology Associates of Southwest Virginia, Inc.
Salem, Virginia, United States, 24153
United Kingdom
Royal Marsden Hospital
London, United Kingdom, SW3 6JJ
Sponsors and Collaborators
BioVex Limited
  More Information

Additional Information:
No publications provided

Responsible Party: Robert Coffin, PhD, BioVex
ClinicalTrials.gov Identifier: NCT01368276     History of Changes
Other Study ID Numbers: 005/05-E
Study First Received: April 20, 2011
Last Updated: June 15, 2011
Health Authority: United States: Food and Drug Administration
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by BioVex Limited:
Melanoma
Stage IIIb, IIIc and IV Disease
oncolytic
OncoVex
OncoVEXGM-CSF

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

ClinicalTrials.gov processed this record on August 01, 2014