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

This study has been completed.
Sponsor:
Collaborators:
Bayer
Chiron Corporation
Information provided by (Responsible Party):
Jose Lutzky, Mt. Sinai Medical Center, Miami
ClinicalTrials.gov Identifier:
NCT00616564
First received: February 4, 2008
Last updated: May 2, 2012
Last verified: May 2012
  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 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Primary Objective [ Time Frame: one - two years ] [ Designated as safety issue: No ]
    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


Enrollment: 36
Study Start Date: February 2006
Study Completion Date: September 2009
Primary Completion Date: September 2009 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00616564

Locations
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
Bayer
Chiron Corporation
Investigators
Study Chair: Jose Lutzky, M.D. Mount Sinai Medical Center Miami Beach
  More Information

No publications provided

Responsible Party: Jose Lutzky, Principal Investigator Jose Lutzky, M.D., Mt. Sinai Medical Center, Miami
ClinicalTrials.gov Identifier: NCT00616564     History of Changes
Other Study ID Numbers: MEL0105
Study First Received: February 4, 2008
Last Updated: May 2, 2012
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas

ClinicalTrials.gov processed this record on August 27, 2014