Extension study of Oncovex GM-CSF in patients with melanoma

• Research type

  Research Study

• Full title

  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

• IRAS ID

  60560

• Contact name

  Kevin Harrington

• Sponsor organisation

  BioVex Inc.

• Eudract number

  2010-021070-11

• ISRCTN Number

  not issued

• Research summary

  OncoVEX GM-CSF is being developed by BioVex Inc. for the treatment of melanoma. OncoVEX GM-CSF is a herpes simplex virus that has been genetically changed to grow in and destroy cancer cells. It also delivers a gene for a substance call GM-CSF (granulocyte macrophage - colony stimulating factor), which signals the body's immune system to become more active and may help it to attack the cancer. The purpose of this study is to learn about the safety and risks of OncoVEX GM-CSF in patients who have already received treatment with OncoVEXGM-CSF in study 005/05, and to see if extended treatment with OncoVEX GM-CSF can destroy melanoma tumors (cancerous growths on the skin) as it destroyed tumors in animal tests and in other human studies.This study is an extension to BioVex Inc. protocol 005/05 and is only available to patients that are currently or were previously enrolled in protocol 005/05. Patients must either have received the maximum number of OncoVEX GM-CSF treatment injections allowable under the 005/05 protocol with both the investigator and the sponsor??s medical monitor in agreement that further treatment is warranted (e.g., those patients who do not have clinically relevant progressive disease), or must have new injectable lesion(s) that have appeared after previous resolution of all injectable disease while on study 005/05. Patients will continue to receive OncoVEX GM-CSF, according to the 005/05 protocol schedule, with one cycle of OncoVEX GM-CSF treatment administered on Days 1 and 15 of each 28 day cycle. Study treatment will be continued until either a complete response is achieved, the patient has clinically significant disease progression, the patient receives 24 doses or has been on therapy for 12 months (whichever is longest), the patient experiences an unacceptable toxicity, dies or until another criterion for withdrawal from the study is met.

• REC name

  London - West London & GTAC Research Ethics Committee

• REC reference

  10/H0707/73

• Date of REC Opinion

  23 Nov 2010

• REC opinion

  Further Information Favourable Opinion