Unresectable Stage IIIb, IIIc and IV Melanoma
Conditions
Interventions
Product Name: OncoVEX GM-CSF
Pharmaceutical Form: Solution for injection
Current Sponsor code: OncoVEX GM-CSF
Concentration unit: PFU/ml plaque forming
Sponsors
BioVex Inc
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Previously participated in protocol 005/05 and: a. received the maximum number of OncoVEXGM-CSF treatment injections or cycles of GM-CSF allowable for that patient on study 005/05, or b. new lesion(s) appeared after 12 months from randomization after previous resolution of all disease while on study 005/05. New injectable lesions must have appeared within = 12 months from the End of Treatment visit on the 005/05 study. 2. In the opinion of the investigator further treatment is warranted (e.g., those patients who do not have PDr). 3. Performance status (ECOG) 0 or 1. 4. For patients randomized to OncoVEXGM-CSF only: 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. 5. Must not have received additional anti-tumor therapies for melanoma after end of treatment on Study 005/05 and prior to enrollment into Study 005/05E. Note: Patients who received radiation therapy for palliation or underwent surgical resection of melanoma tumor since end of treatment on Study 005/05 will not be excluded. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Patients will be excluded if they have: 1.Prior CTCAE grade 3 or 4 toxicity related to 005/05 study treatment 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 005/05 study treatment. 3.History of Grade 3 arthralgia/myalgias while on 005/05 study treatment. 4.History of = Grade 2 autoimmune reactions, allergic reactions or urticaria or other treatment-related non-hematological toxicities while on study treatment that required a dose delay or discontinuation of therapy. 5.PDr while participating in study 005/05 6.Patient requested to be withdrawn from study 005/05 or was unable to comply with the demands of the 005/05 trial. 7.At the discretion of the investigator, patient was withdrawn from the 005/05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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objectives of this study are: • To provide extended treatment with OncoVEX GM-CSF or GM-CSF • To evaluate safety ; Secondary Objective: The secondary objectives of this study are: • To evaluate objective tumor response rate (CR and PR using protocol guidelines) • To evaluate durable response rate, defined as the rate of objective response (CR or PR) lasting continuously for 6 or more months ; Primary end point(s): The primary endpoint is safety. Assessments for safety will include all patients treated on the extension protocol. Patients who consent to the study but withdraw before receiving any extension study treatment will be excluded from the safety assessment, but will still be followed for response and survival under the main 005/05 protocol. Safety assessments will be based on adverse events, laboratory data, concomitant medications, the results of physical examinations and vital signs. Safety will be evaluated using the NCI Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 3.0, based on recorded adverse events, physical examinations, and clinical laboratory assessments. All adverse events will be coded according to Medical Dictionary for Regulatory Activities (MedDRA) version 10.1 or later. If a patient experiences multiple events that map to a single adverse event, the greatest severity and strongest investigator assessment of relation to study drug will be assigned to the adverse event. | — |
Countries
United Kingdom
Outcome results
None listed