Clinical Trials

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

Location:

Trial status:

Inactive

Why is this study being done?

This study is being conducted to learn about the safety and risks of using OncoVEXGM-CSF to treat patients with melanoma and to see if OncoVEXGM CSF can destroy these tumours compared to GM-CSF. This study may provide information on the usefulness of OncoVEXGM-CSF as a future treatment for melanoma. This study may also provide information on the safety and usefulness of GM-CSF as compared to OncoVEXGM-CSF as a treatment for melanoma.

Who is eligible to participate?

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

Last updated: 06/01/2012

NCT ID:

NCT00769704