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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

Phase 3
18 Years
Open (Enrolling by invite only)

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Trial Information

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

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 Patient requested to be withdrawn from study 005/05 or was unable to comply with the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 At the discretion of the investigator, patient was withdrawn from the 005/05 trial.

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To evaluate safety

Outcome Description:

Safety assessments will be based on adverse events, laboratory data, concomitant medications, the results of physical examinations and vital signs.

Outcome Time Frame:

12 months

Safety Issue:



United States: Food and Drug Administration

Study ID:




Start Date:

October 2010

Completion Date:

June 2013

Related Keywords:

  • Melanoma
  • Melanoma
  • Stage IIIb, IIIc and IV Disease
  • oncolytic
  • OncoVex
  • Melanoma



Huntsman Cancer InstituteSalt Lake City, Utah  84112
James Graham Brown Cancer CenterLouisville, Kentucky  40202
Rush University Medical CenterChicago, Illinois  60612-3824
Oncology and Hematology Associates of Southwest Virginia, Inc.Roanoke, Virginia  24014
Mary Crowley Medical Research CenterDallas, Texas  75246
Indiana UniversityIndianapolis, Indiana  46202
Hubert H Humphrey Cancer CenterRobbinsdale, Minnesota  55422
University of Iowa Hospitals & ClinicsIowa City, Iowa  52242
University of North Carolina At Chapel Hill School of MedicineChapel Hill, North Carolina  27599