Metastatic Melanoma Clinical Trial
Official title:
A Phase II Trial of the Combination of Rituxan and Abraxane for the Treatment of Patients With Inoperable Stage III and IV Malignant Melanoma
The purpose of this research study is to test an experimental combination of drugs to determine if they can cause shrinkage or even complete disappearance of your melanoma. The two drugs being tested in combination are Rituxan and Abraxane
Rituxan and Abraxane are approved for the treatment of other cancers, but not for melanoma.
Candidates for this study have melanoma that has spread to their lymph nodes or internal
organs and that cannot be removed by a surgical procedure.
The safety of this combination of drugs will also be looked at throughout this study.
Rituxan will be administered IV at weeks 1 and 3 of each cycle. Abraxane will be
administered IV weekly for 3 consecutive weeks. This is followed by 1 week of rest after
which, the cycle is repeated. Following the second cycle, there will be a 4-week period of
rest. Evaluation of response will occur on day 71 +/-3 days. If either disease stabilization
or clear evidence of clinical response is observed two additional cycles of treatment will
be administered. Lesions will be measured on the scan (CT or PET/CT), x-ray
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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