Efficacy and Safety Study of OncoVEXGM-CSF Compared to GM-CSF in Melanoma

Inclusion Criteria:

• Males or females age ≥ 18 years
• Stage IIIb, IIIc or stage IV disease that is not surgically resectable
• Injectable disease (i.e. suitable for direct injection or through the use of ultrasound guidance)
• at least 1 injectable cutaneous, subcutaneous or nodal melanoma lesion >10 mm in longest diameter or, multiple injectable melanoma lesions which in aggregate have a longest diameter of >10 mm
• Serum LDH levels less than 1.5 x ULN
• ECOG Performance Status of 0 or 1
• Prolongation in INR, PT, and PTT when the result is from therapeutic anticoagulation treatment are permitted for patients whose injectable lesions are cutaneous and/or subcutaneous such that direct pressure could be applied in the event of excessive bleeding

Exclusion Criteria:

• Clinically active cerebral or any bone metastases. Patients with up to 3 (neurological performance status of 0) cerebral metastases may be enrolled, provided that all lesions have been adequately treated with stereotactic radiation therapy, craniotomy, gammaknife therapy, with no evidence of progression, and have not required steroids, for at least two (2) months prior to randomization
• Greater than 3 visceral metastases (this does not include lung metastases or nodal metastases associated with visceral organs). For patients with <3 visceral metastases, no lesion >3 cm, and liver lesions must meet RECIST criteria for SD for at least 1 month prior to randomization