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

May 2, 2012 updated by: Jose Lutzky, Mt. Sinai Medical Center, Miami

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Miami Beach, Florida, United States, 33140
        • Jose Lutzky, MD
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • David Lawson, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 90 years (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Primary Objective
Time Frame: 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
one - two years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mt. Sinai Medical Center, Miami

Collaborators

Bayer
Chiron Corporation

Investigators

  • Study Chair: Jose Lutzky, M.D., Mount Sinai Medical Center Miami Beach

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2006

Primary Completion (ACTUAL)

September 1, 2009

Study Completion (ACTUAL)

September 1, 2009

Study Registration Dates

First Submitted

February 4, 2008

First Submitted That Met QC Criteria

February 14, 2008

First Posted (ESTIMATE)

February 15, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

May 3, 2012

Last Update Submitted That Met QC Criteria

May 2, 2012

Last Verified

May 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MEL0105

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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