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

NCT ID: NCT00616564

Last Updated: 2012-05-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-02-28
• Study Completion Date: 2009-09-30

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.

Conditions

Malignant Melanoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

GM-CSF

Concomitant Priming with GM-CSF

Intervention Type: DRUG

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.

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bayer

INDUSTRY

Sponsor Role: collaborator

Chiron Corporation

INDUSTRY

Sponsor Role: collaborator

Mt. Sinai Medical Center, Miami

OTHER

Sponsor Role: lead

Responsible Party

Jose Lutzky

Principal Investigator Jose Lutzky, M.D.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jose Lutzky, M.D.

Role: STUDY_CHAIR

Mount Sinai Medical Center Miami Beach

Locations

Jose Lutzky, MD

Miami Beach, Florida, United States

David Lawson, MD

Atlanta, Georgia, United States

Countries

United States

Other Identifiers

MEL0105

Identifier Type: -

Identifier Source: org_study_id