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Investigator(s):
Steven A. Rosenberg, M.D., Ph.D. Principal Investigator Phone: 1-866-820-4505 (Toll Free) ncisbirc@mail.nih.gov
Referral Contact(s):
Linda Williams, R.N. Research Nurse Phone: 1-866-820-4505 (Toll Free) Fax: 301-451-1927 ncisbirc@mail.nih.gov	June A. Kryk, R.N. Research Nurse Phone: 1-866-820-4505 (Toll Free) Fax: 301-451-1927 ncisbirc@mail.nih.gov

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Primary Eligibility:

• Histologically confirmed diagnosis of one of the following:
• Melanoma
  • Metastatic disease
• Renal-cell carcinoma
• Locally advanced and unresectable disease OR metastatic disease
• Refractory to standard therapy OR ineligible to receive standard therapy
• Measurable or evaluable disease
• Previously received high-dose interleukin-2 OR have a contraindication for this treatment
• No previously untreated or unstable brain metastases
• No splenic metastasis
• ≥ 18 years of age
• ECOG performance status ≤ 2
• Measurable or evaluable disease according to RECIST criteria
• AST and ALT < 2.5 x the upper limit of normal (ULN) or conjugated bilirubin < 1.25 x ULN
• Absolute neutrophil count > 1000/mm³, platelets > 100,000/mm³, PT/PTT within 1.5 x ULN
• Serum creatinine < 1.5 x ULN
• Must have a normal stress cardiac test (stress thallium, stress MUGA, dobutamine echocardiogram, or other stress test) as evidenced by LVEF ≥ 45% if:
• ≥ 50 years of age
• History of EKG abnormalities or symptoms of cardiac ischemia
• Familial or personal history of heart failure or received antimitotic agents susceptible to trigger heart failure
• History of cigarette smoking or symptoms of respiratory dysfunction must have a normal pulmonary function test as evidenced by a FEV1 > 60% predicted
• No concomitant liver disease, such as acute hepatitis, including hepatitis A, acute alcoholic hepatitis, or documented hepatitis, including NASH
• No cytotoxic therapy, immunotherapy by cytokines, anti-tumor vaccines, or monoclonal antibody in the 4 weeks prior to the initiation of study treatment

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Treatment Plan:

This is a phase I dose-escalation study.

• Patients receive CYT107 (glycosylated human IL-7) weekly by subcutaneous injection for 3 consecutive weeks
• Patients with normal lymphocyte counts will be assigned to a dose level in sequential order (Arm I)
• Patients in Arm I will receive CYT107 (glycosylated human IL-7) escalating through 5 dose levels
• Each dose level is administered to 6 patients to determine the maximum tolerated dose
• Patients who are lymphopenic will begin enrollment in Arm II and be assigned to the dose level just below the patients in Arm I and dose escalate in sequential order

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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.
• PDQ (Physicians Data Query) - provides additional details about this study for health care providers.

Reviewed: 12/5/08
Updated: 1/13/09