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
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
17
The dose of Rituxan is 375 mg/m2¬ administered as an IV infusion during weeks 1 \& 3 (days 1 \& 15)Abraxane will be administered at a fixed dose of 100 mg/m2 as an IV infusion weekly for three weeks in a row followed by one week of rest
California Cancer Associates For Research,cCARE
Encinitas, California, United States
RECRUITINGOverall response as determined by a Percent change (%) in the sum of the diameters of target lesions.
Evaluation of response (Progression Free and overall survival will be determined by measuring and recording the largest diameter of a lesion. Add these values together and record the value as the sum of the largest diameters.The percent change will be obtained according to the following formula: Percent change = sum of the longest diameter at 12weeks X 100 Sum of the longest diameters pre treatment
Time frame: baseline-12 weeks
Response rate as Percent change in diameter (mm) of target lesions
Overall response rate ( complete response + Partial response) will be determined by the disappearance of lesions or a reduction of target lesions in short axis to \<10mm (CR) + at least a 30% decrease in the sum of the longest diameters of the target lesions (PR).
Time frame: 2 years
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