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Phase II Trial of (IL-2) With Priming and (GM-CSF) in Patients With Advanced Melanoma
This study is currently recruiting participants.
Verified by Mt. Sinai Medical Center, Miami, February 2008
Sponsors and Collaborators: Mt. Sinai Medical Center, Miami
Bayer
Chiron Corporation
Information provided by: Mt. Sinai Medical Center, Miami
ClinicalTrials.gov Identifier: NCT00616564
  Purpose

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 Intervention Phase
Malignant Melanoma
Drug: GM-CSF
Phase II

MedlinePlus related topics: Melanoma
Drug Information available for: Sargramostim Granulocyte-macrophage colony-stimulating factor
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title: Multicenter Phase II Trial of High-Dose Interleukin (IL-2) With Priming and Concomitant Sargramostim (GM-CSF) in Patients With Advanced Melanoma

Further study details as provided by Mt. Sinai Medical Center, Miami:

Estimated Enrollment: 35
Study Start Date: February 2006
Estimated Study Completion Date: February 2010
Estimated Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: GM-CSF
    Concomitant Priming with GM-CSF
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.

  Eligibility

Ages Eligible for Study:   16 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00616564

Contacts
Contact: Jose Lutzky, MD 305-535-3300 jlutzky@aptiumoncology.com
Contact: Yvonne Nunez 305-535-3350 yenrique@msmc.com

Locations
United States, Florida
Jose Lutzky, MD Recruiting
Miami Beach, Florida, United States, 33140
Contact: Yvonne Nunez     305-535-3350     yenrique@msmc.com    
United States, Georgia
David Lawson, MD Not yet recruiting
Atlanta, Georgia, United States, 30322
Contact: David Lawson, MD     404-778-1900     david_lawson@emoryhealthcare.org    
United States, New York
Janice Dutcher, M.D. Not yet recruiting
Bronx, New York, United States, 10466
Contact: Janice Dutcher, MD     718-920-9900     jpd440@aol.com    
Sponsors and Collaborators
Mt. Sinai Medical Center, Miami
Bayer
Chiron Corporation
  More Information

Responsible Party: Mt. Sinai Medical Center ( Jose Lutzky, M.D. )
Study ID Numbers: MEL0105
Study First Received: February 4, 2008
Last Updated: February 14, 2008
ClinicalTrials.gov Identifier: NCT00616564  
Health Authority: United States: Institutional Review Board

Keywords provided by Mt. Sinai Medical Center, Miami:
GM-CSF
Interleukin
IL-2
Sargrostim

Study placed in the following topic categories:
Neuroectodermal Tumors
Nevus, Pigmented
Neoplasms, Germ Cell and Embryonal
Neuroepithelioma
Nevus
Neuroendocrine Tumors
Melanoma

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas

ClinicalTrials.gov processed this record on January 14, 2009