Clinical trial NCT00616564: Phase II Trial of (IL-2) With Priming and (GM-CSF) in Patients With Advanced Melanoma
Official title: Multicenter Phase II Trial of High-Dose Interleukin (IL-2) With Priming and Concomitant Sargramostim (GM-CSF) in Patients With Advanced Melanoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Malignant Melanoma
Keywords: GM-CSF
Interleukin
IL-2
Sargrostim
Lead sponsor: Mt. Sinai Medical Center, Miami
Sponsor class: OTHER
Collaborators: name: Bayer
name: Chiron Corporation
First posted: 2008-02-15
Enrollment: 36
Sex: ALL
Minimum age (years): 16
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Primary Objective
timeFrame: one - two years
Secondary outcomes:
Other outcomes:
Locations:
city: Miami Beach
country: United States
facility: Jose Lutzky, MD
state: Florida
city: Atlanta
country: United States
facility: David Lawson, MD
state: Georgia
Study officials:
affiliation: Mount Sinai Medical Center Miami Beach
name: Jose Lutzky, M.D.
role: STUDY_CHAIR
References: