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

April 20, 2011
June 15, 2011
October 2010
June 2013   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01368276 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
An Extended Use Study of Safety and Efficacy of OncoVEXGM-CSF in Melanoma
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

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.

Not Provided
Interventional
Phase 3
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Melanoma
Biological: OncoVEXGM-CSF
Up to 4 mL of 10^8 pfu/mL/per injection
Experimental: OncoVEXGM-CSF
Intervention: Biological: OncoVEXGM-CSF
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
25
June 2013
June 2013   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   United Kingdom
 
NCT01368276
005/05-E
Not Provided
Robert Coffin, PhD, BioVex
BioVex Limited
Not Provided
Not Provided
BioVex Limited
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP