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Investigator(s):
John C. Morris, M.D. Principal Investigator Phone: 301-402-2912 jmorris@mail.nih.gov
Referral Contact(s):
Brenda Roberson, R.N., O.C.N. Research Nurse Phone: 301-435-4733 broberson@mail.nih.gov

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Primary Eligibility:

• Patients with metastatic malignant melanoma
• Failed ≥ 1 prior therapy
• ECOG 0–2
• Adequate organ function: HGB > 10 gm/dL, ANC > 1500/mm³, ALT/AST < 2.5 x ULN, Creatinine < 2 mg/dL , normal PT/PTT, Albumin > 3 g/dL
• Measurable disease by RECIST
• HBV, HCV and HIV negative
• No history of brain metastasis
• No coagulation disorders
• No anticoagulant medications

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Study Outline:

• GC1008 15 mg/kg
• 4 doses per treatment cycle; if responding, patients may receive up to 2 more cycles
• GC1008 will be administered on Day 0, 28, 42, and 56 during the first treatment cycle
• Patients whose tumors respond may be eligible for additional cycles with GC1008 administered every 2 weeks
• Skin biopsies are required before and after treatment

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Additional Information:

• This trial will be conducted at the NIH Clinical Center in Bethesda, MD. It is open to patients who meet the eligibility requirements, regardless of where they live in the United States.
• There is no charge for medical care received at NIH Clinical Center.
• FAQs about this study - provides information for patients about the trial such as frequency and duration of visits, costs, how to enroll, treatment plan.
• PDQ (Physicians Data Query) - provides additional details about this study for health care providers.

Reviewed: 5/27/09
Updated: 10/31/08