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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00616564
Recruitment Status : Completed
First Posted : February 15, 2008
Last Update Posted : May 3, 2012
Chiron Corporation
Information provided by (Responsible Party):
Jose Lutzky, Mt. Sinai Medical Center, Miami

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.

Condition or disease Intervention/treatment Phase
Malignant Melanoma Drug: GM-CSF Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : February 2006
Actual Primary Completion Date : September 2009
Actual Study Completion Date : September 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Melanoma

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

Primary Outcome Measures :
  1. 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

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 90 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00616564

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United States, Florida
Jose Lutzky, MD
Miami Beach, Florida, United States, 33140
United States, Georgia
David Lawson, MD
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Mt. Sinai Medical Center, Miami
Chiron Corporation
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Study Chair: Jose Lutzky, M.D. Mount Sinai Medical Center Miami Beach

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Responsible Party: Jose Lutzky, Principal Investigator Jose Lutzky, M.D., Mt. Sinai Medical Center, Miami Identifier: NCT00616564    
Other Study ID Numbers: MEL0105
First Posted: February 15, 2008    Key Record Dates
Last Update Posted: May 3, 2012
Last Verified: May 2012
Keywords provided by Jose Lutzky, Mt. Sinai Medical Center, Miami:
Additional relevant MeSH terms:
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Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas
Immunologic Factors
Physiological Effects of Drugs