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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00616564

Enrollment

Registered

2008-02-15

Start date

2006-02-28

Completion date

2009-09-30

Last updated

2012-05-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malignant Melanoma

Keywords

GM-CSF, Interleukin, IL-2, Sargrostim

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.

Interventions

DRUGGM-CSF

Concomitant Priming with GM-CSF

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

16 Years to 90 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Primary Objective	one - two years	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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026