At a glance
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A Phase II Evaluation of Docetaxel and Vinorelbine Plus Sargramostim in Patients With Metastatic Malignant Melanoma
In Brief
A Phase 2 clinical trial evaluating Vinorelbine, Docetaxel, and 1 other intervention for Metastatic Melanoma. Completed, enrolled 52 participants across 1 site.
Detailed Summary
This is a Phase II Evaluation of Docetaxel and Vinorelbine Plus Sargramostim in subjects who have metastatic melanoma which has advanced beyond the point at which local therapies such as surgery or radiation therapy would be helpful. Without effective treatment, metastatic melanoma is usually a severe and fatal disease. Chemotherapy agents or combinations of chemotherapy agents have produced tumor shrinkage in some patients, which has occasionally persisted. This research involves treatment with a combination of chemotherapy drugs known to be active against melanoma alone. The investigational purpose of this study is to determine if the combination of docetaxel, vinorelbine and sargramostim will produce a response (complete or partial) in metastasis melanoma. The researchers also wants to find out what side effects are associated with this combination of drugs.
Study Details
Timeline
Interventions
30 mg/m2 IV over 6-10 min every 14 days
40mg/m2 IV over 1 hour every 14 days
250 mcg/m2 subcutaneous (SQ) daily (QD) x 10 days