Clinical Trial VICCMEL1130
An Extension Protocol to Evaluate the Efficacy and Safety of Extended Use Treatment with OncoVEXGM-CSF or GM-CSF for Eligible Melanoma Patients Participating in Study 005/05
- Protocol No. VICCMEL1130
- Open Date: 02/08/2012
- Staging: Phase III
- Age Group: Adults
- Scope: International
- Objective: 1. To provide extended treatment with OncoVEXGM-CSF or GM-CSF 2. To evaluate safety
- Disease Sites: Melanoma
- Therapies: Molecular Targeted Agents / Immunotherapy / Biologics
- Drugs: GM-CSF; OncoVEX GM-CSF; Talimogene laherparepvec
- Participating Institutions: Vanderbilt University
- National Clinical Trial ID: NCT01368276
- Secondary Protocol No: Grant number: 005/05-E
Patients are being asked to take part in this research study because they have melanoma (a type of skin cancer). The purpose of this study is learn about the safety and the risks of using OncoVEXGM-CSF to treat patients with melanoma who have already received treatment with OncoVEXGM-CSF and to see if OncoVEXGM-CSF can destroy tumors. This study may also help us learn how safe and useful OncoVEXGM-CSF is as a future treatment for melanoma. Patients may be able to take part in this study because they have taken part in study 005/05 (MEL 0905), -A Randomized Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of Treatment with OncoVEXGM-CSF Compared to Subcutaneously Administered GM-CSF in Melanoma Patients with Unresectable Stage IIIb, IIIc and IV Disease.- OncoVEXGM-CSF is an investigational drug. That means it is not approved by the Food and Drug Administrtion (FDA) to treat melanoma. It is a weakened virus that may directly destroy tumor cells and possibly help the immune system to kill tumor cells. The total number of people that will take part in this study is difficult to predict as not all patients from the 005/05 (MEL 0905) study will be eligible to take part nor will all eligible patients wish to take part. About 25 people will be taking part in the 005/05 (MEL 0905) study at Vanderbilt. We expect to enroll about 5 patients on this study. The study is sponsored by BioVex Inc - the drug company that is paying for the study.
|Ages Eligible for Study:||18 Years and older|
|Genders Eligible for Study:||Both|
|Accepts Healthy Volunteers:||No|
1. Previously participated and was randomized to the OncoVEXGM-CSF arm in protocol 005/05 and:
1. received the maximum number of OncoVEXGM-CSF treatment injections allowable for that patient on study 005/05, or
2. new injectable lesion(s) appeared after previous resolution of all injectable disease while on study 005/05.
2. In the opinion of the investigator and the sponsor's medical monitor further treatment is warranted [e.g., those patients who do not have clinically relevant progressive disease (PDr)].
3. Performance status (Eastern Co-Operative Oncology Group, ECOG) 0 or 1.
4. 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.
1. Prior CTCAE (Common Terminology Criteria for Adverse Events) grade 3 or 4 toxicity related to OncoVEXGM-CSF 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 OncoVEXGM-CSF treatment.
3. History of Grade 3 arthralgia/myalgias while on OncoVEXGM-CSF treatment.
4. History of ≥ Grade 2 autoimmune reactions, allergic reactions or urticaria or other OncoVEXGM-CSF related non-hematological toxicities while on OncoVEXGM-CSF treatment that required a dose delay or discontinuation of OncoVEXGM-CSF 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.