NCT02142335

Rituxan and Abraxane for the Treatment of Patients With Inoperable Stage III and IV Malignant Melanoma

A Phase II Trial of the Combination of Rituxan and Abraxane for the Treatment of Patients With Inoperable Stage III and IV Malignant Melanoma

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 17 (estimated)
• Sponsor: California Cancer Assocaties for Research & Excellence · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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

Conditions

• Malignant Melanoma of Skin Stage III
• Metastatic Melanoma

Interventions

Type	Name	Description
DRUG	Rituxan	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

Timeline

• Start date: 2014-03-01
• Primary completion: 2015-03-01
• Completion: 2016-03-01
• First posted: 2014-05-20
• Last updated: 2014-05-20

Locations

1 site across 1 country: United States