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

Malignant Melanoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00616564
• Other study ID #: MEL0105
• Status: Completed
• Phase: Phase 2
• First received: February 4, 2008
• Last updated: May 2, 2012
• Start date: February 2006
• Est. completion date: September 2009

Study information

• Verified date: May 2012
• Source: Mt. Sinai Medical Center, Miami
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: September 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Malignant Melanoma
• Melanoma

Intervention

Drug:
• GM-CSF
Concomitant Priming with GM-CSF

Locations

Country	Name	City	State
United States	David Lawson, MD	Atlanta	Georgia
United States	Jose Lutzky, MD	Miami Beach	Florida

Sponsors (3)

Lead Sponsor	Collaborator
Mt. Sinai Medical Center, Miami	Bayer, Chiron Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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