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Sponsors and Collaborators: |
Mt. Sinai Medical Center, Miami Bayer Chiron Corporation |
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Information provided by: | Mt. Sinai Medical Center, Miami |
ClinicalTrials.gov Identifier: | NCT00616564 |
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 |
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Malignant Melanoma |
Drug: GM-CSF |
Phase II |
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 |
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) |
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.
Ages Eligible for Study: | 16 Years to 90 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Adequate major organ function to tolerate therapy, as defined by:
Exclusion Criteria:
Contact: Jose Lutzky, MD | 305-535-3300 | jlutzky@aptiumoncology.com |
Contact: Yvonne Nunez | 305-535-3350 | yenrique@msmc.com |
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 | Recruiting |
Atlanta, Georgia, United States, 30322 | |
Contact: David Lawson, MD 404-778-1900 david_lawson@emoryhealthcare.org |
Responsible Party: | Mt. Sinai Medical Center ( Jose Lutzky, M.D. ) |
Study ID Numbers: | MEL0105 |
Study First Received: | February 4, 2008 |
Last Updated: | February 4, 2009 |
ClinicalTrials.gov Identifier: | NCT00616564 History of Changes |
Health Authority: | United States: Institutional Review Board |
GM-CSF Interleukin IL-2 Sargrostim |
Neuroectodermal Tumors Nevus, Pigmented Neoplasms, Germ Cell and Embryonal Neuroepithelioma |
Nevus Neuroendocrine Tumors Melanoma |
Neuroectodermal Tumors Neoplasms Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal |
Neoplasms, Nerve Tissue Nevi and Melanomas Neuroendocrine Tumors Melanoma |