Efficacy and Safety Study of OncoVEXGM-CSF Compared to GM-CSF in Melanoma
Basic Trial Information
|Phase III||Treatment||Completed||18 and over||Pharmaceutical / Industry||005/05|
The objective of this study is to evaluate the efficacy and safety of treatment with OncoVEXGM-CSF compared to subcutaneously administered GM-CSF melanoma patients with unresectable Stage IIIb, IIIc and Stage IV disease. The efficacy endpoints of the study aim to demonstrate overall clinical benefit for patients treated with OncoVEXGM-CSF as compared to GM-CSF.
Further Study Information
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.
- 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
- 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
Trial Contact Information
Trial Lead Organizations/Sponsors
- Amgen, Incorporated
Link to the current ClinicalTrials.gov record.
NLM Identifier NCT00769704
ClinicalTrials.gov processed this data on January 27, 2015
Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.