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Sponsored by: |
BioVex Limited |
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Information provided by: | BioVex Limited |
ClinicalTrials.gov Identifier: | NCT00769704 |
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.
Condition | Intervention | Phase |
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Melanoma |
Biological: OncoVEXGM-CSF Biological: GM-CSF |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Randomized Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of Treatment With OncoVEXGM-CSF Compared to Subcutaneously Administered GM-CSF in Previously Treated Melanoma Patients With Unresectable Stage IIIb, IIIc and IV Disease |
Estimated Enrollment: | 430 |
Study Start Date: | April 2009 |
Estimated Study Completion Date: | June 2012 |
Estimated Primary Completion Date: | June 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
OncoVEXGM-CSF
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Biological: OncoVEXGM-CSF
Up to 4 mL of 10^8 pfu/mL/per injection
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2: Active Comparator
GM-CSF
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Biological: GM-CSF
125 µg/m2 daily subcutaneously for 14 consecutive days followed by 14 days of rest
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study Director: | Howard Goldsweig, MD | BioVex Limited |
Responsible Party: | BioVex ( Robert Coffin, PhD ) |
Study ID Numbers: | 005/05 |
Study First Received: | October 7, 2008 |
Last Updated: | April 28, 2009 |
ClinicalTrials.gov Identifier: | NCT00769704 History of Changes |
Health Authority: | United States: Food and Drug Administration; United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Melanoma OncoVEXGM-CSF GM-CSF |
Stage IIIb, IIIc and IV Disease oncolytic OncoVex |
Neuroectodermal Tumors Nevus, Pigmented Neoplasms, Germ Cell and Embryonal Neuroepithelioma |
Nevus Neuroendocrine Tumors Melanoma |
Neuroectodermal Tumors Neoplasms Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal |
Neoplasms, Nerve Tissue Nevi and Melanomas Neuroendocrine Tumors Melanoma |