Trial of ABI-007 in Previously Treated Patients With Metastatic Melanoma

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

This trial will treat patients previously treated for advanced (metastatic) melanoma (skin cancer) with a new chemotherapeutic medicine. The new chemotherapy will be administered weekly in cycles of three weekly doses followed by one week rest. A minimum of three cycles of therapy will be given to determine the anti-tumor response of the new chemotherapy. Patients may continue to stay on therapy a maximum of 9-12 cycles if treatment shows continuing benefit.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Celgene; Celgene Corporation
• Treatments: Albumin-Bound Paclitaxel; Paclitaxel

Criteria

Inclusion Criteria:

• Confirmed Metastatic Melanoma

• At least 18 years old

• No other active malignancy

• Hemoglobin at least 9

• Platelet Count at least 100,000 cells/mm3

• ANC at least 1500 cells/mm3

• AST & ALT less than 2.5X upper limit of normal

• Total bilirubin less than 1.5mg/dL

• Creatine less than 1.5 mg/dL

• Alkaline phosphatase less than 2.5X upper limit of normal

• Life expectancy of at least 12 weeks

• ECOG performance status of 0-1

• Patient must provide informed consent

• Patient must provide authorization to disclose

Exclusion Criteria:

• Evidence of active brain metastases

• The only evidence of metastasis is lytic or blastic bone metastases

• Pre-existing peripheral neuropathy of NCI Toxicity Criteria Scale of grade greater than 2

• Received radiotherapy in last 4wks, except if to a non-target lesion only

• Clinically significant concurrent illness

• Investigator's opinion that patient unlikely to complete study

• Cytotoxic chemotherapeutic agent treatment or investigational drug within previous 4wks

• History of allergy/hypersensitivity to study drug

• Serious Medical Risk Factors determine by the investigator