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

Study Overview
=================
Brief 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.

Detailed Description
-----------------
The primary objectives of this phase II multicenter trial are to: Determine the 1 and 2-year survival of patients treated according to protocol. Assess the safety and toxicity of this regimen in this patient population. The secondary objectives are to: Determine the freedom from progression (FFP). Measure the response rate (RR). Obtain immunological data from the use of this regimen in vivo (as separate project: Moffitt?). The proposed study is a multicenter phase II trial of HD-IL-2 in combination with GM-CSF. GM-CSF will be started 7 days before day 1 of HD-IL-2 and will be continued for 4 weeks to day 28, encompassing two cycles of HD-IL2. The first 9 patients will be closely monitored for unexpected toxicity.

Official Title
-----------------
Multicenter Phase II Trial of High-Dose Interleukin (IL-2) With Priming and Concomitant Sargramostim (GM-CSF) in Patients With Advanced Melanoma

Conditions
-----------------
Malignant Melanoma

Intervention / Treatment
-----------------
* Drug: GM-CSF


Participation Criteria
=================
Eligibility 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.

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 90 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: GM-CSF|Concomitant Priming with GM-CSF|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Objective | Determine the 1 and 2-year survival of patients treated according to protocol. Assess the safety and toxicity of this regimen in this patient population | one - two years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
GM-CSF, Interleukin, IL-2, Sargrostim