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

• Status: Completed
• Trial end date: 2009-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

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

Details

• Lead Sponsor: Mt. Sinai Medical Center, Miami
• Collaborators: Bayer; Chiron Corporation

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.