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Trial of ABI-007 in Previously Treated Patients With Metastatic Melanoma
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
Read our disclaimer for details.
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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study:
18 Years and older (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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
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