Phase II Trial of (IL-2) With Priming and (GM-CSF) in Patients With Advanced Melanoma

Completed · Phase 2

Conditions studied: Malignant Melanoma

In brief

High-dose IL-2 treatment for metastatic melanoma has been approved by the FDA in 1998. Studies of GM-CSF plus IL-2 have not addressed the approved dose and schedule. This protocol will study the combination of HD-IL2 and GM-CSF given the potential synergistic interactions discussed above.

Key facts

Study ID

NCT00616564

Run by

Mt. Sinai Medical Center, Miami

People needed

36

Starts

2006-02-01

Expected to finish

2009-09-01

Last updated by the study team

2012-05-03

Who can join

Age: 16 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologically confirmed diagnosis of melanoma with measurable disease
• Patients with stage IV or unresectable advanced melanoma
• Age at least 16 years.
• ECOG performance status of 0-1
• Life expectancy > 3 months
• Adequate major organ function to tolerate therapy, as defined by:
• Total bilirubin 2.0 mg/dL.
• Creatinine 1.8 mg/dL.
• WBC 3,000/mm3.
• Platelet count 100,000/mm3.
• Patients 50 years of age with one or more cardiac risk factors must demonstrate normal exercise stress test, stress thallium test, or comparable cardiac ischemia evaluation
• Left ventricular ejection fraction > 40%
• Women of childbearing age must agree to use barrier method birth control and demonstrate a negative pregnancy test prior to initiation of protocol therapy. Periodic negative urine pregnancy tests will also be required.
• Patients must give written informed consent

You may not qualify if…

• No prior HD- IL-2 for stage IV/unresectable advanced disease. Prior low dose IL-2 is allowed.
• No more than 2 prior chemotherapy regimens are allowed.
• No active CNS metastases. Treated CNS metastases without recurrence or progression for > 8 weeks are allowed.
• No concurrent use of systemic corticosteroids
• Pregnant and/or lactating are excluded
• No concurrent antineoplastic treatments, including chemotherapy, biologic response modifiers, radiation, vaccines, or other experimental therapies.
• No treatment for melanoma within the previous 4 weeks.

Where it is running

• Jose Lutzky, MD — Miami Beach, Florida, United States
• David Lawson, MD — Atlanta, Georgia, United States

Full record on ClinicalTrials.gov

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