Trial Information

Summary: A clinical study evaluating the efficacy, safety, and tolerability of OncoVEX in subjects with inoperable melanoma.

OncoVEX^GM-CSF is the name of the investigational drug (study drug) that will be given to you if you take part in this research study. OncoVEX^GM-CSF is being developed for the treatment of malignant melanoma that can no longer be cured by surgery. An “investigational drug” is one that has NOT been approved by the U.S. Food and Drug Administration (FDA) for sale, but is undergoing testing to find out if it is a safe and effective treatment, so it can be approved for sale in the future. OncoVEX^GM-CSF is currently not available except through this study.

OncoVEX^GM-CSF is a herpes simplex virus (a microscopic life form commonly known as the “cold sore virus”) that has been genetically changed to grow in and destroy cancer cells. It also delivers a gene for a substance called GM-CSF, which signals the body’s immune system (which defends against disease) to attack the cancer. This combination of the virus attacking the cancer and the GM-CSF signaling the immune system to attack the cancer resulted in the destruction of cancer in animal tests. It is unknown if this will occur in people. Thirty patients took part in the first clinical trial of OncoVEX^GM-CSF. These patients received either one or three doses of the study drug.

OncoVEX^GM-CSFwill be injected directly into one or more of tumors that are located in or just below the skin. Not all tumors will be injected. The tumors that are not injected with OncoVEX^GM-CSF may be attacked and destroyed by the immune system. This study will help to find out whether OncoVEX^GM-CSF is able to destroy tumors in these ways.

This is a Phase II study. This term is used to describe the second stage of human testing of an investigational drug. This study is being conducted to learn about the safety and the risks of using OncoVEX^GM-CSF to treat patients with melanoma and to see if OncoVEX^GM-CSF can destroy melanoma tumors like it destroyed tumors in animal tests. This study may provide information on the usefulness of OncoVEX^GM-CSF as a future treatment for melanoma.

Everyone who takes part in this study will be given the study drug, OncoVEX^GM-CSF. There is no “placebo” (inactive substance) in this study.

Subjects who take part in this study will be given two (2) different doses of OncoVEX^GM-CSF: an initial low dose followed three (3) weeks later by a series of the higher dose given every two (2) weeks for up to an additional 23 treatments (up to 24 treatments in all). The total number of treatments will depend on how OncoVEX^GM-CSF is tolerated and the effect it has on tumors.

On each treatment day, OncoVEX^GM-CSF will be injected directly into one or more selected tumors located in or just below the skin. Not all skin tumors will be injected. Injections will be done with a topical anesthetic (numbing medicine).

Inclusion/Exclusion Criteria:

• Eligible subjects will be men and women aged 18 years or older.
• All subjects will have stage IIIc or stage IV melanoma that is inoperable and who have one or more tumors that are accessible for direct injection.
• Subjects must be clinically immunocompetent and must have recovered from prior therapy with at least 4 weeks since the last exposure to chemotherapy or radiotherapy.
• Subjects who have participated in any previous melanoma immunotherapy trial within 3 months or any trial within 1 month prior to this study will not be eligible.
• As well, subjects with metastases to the brain, liver, or bone are excluded.
• Subjects must not be pregnant or lactating, must not have had recent surgery, serious infections, or treatment with antiviral medications.
• In addition, subjects with a history of other malignancies (within 5 previous years) will not be enrolled.
• All subjects must be willing and able to sign informed consent.

For more information,

If you would like to learn more about participating in this study, please send an e-mail message using the form below.