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A Phase II Study of Maintenance Biotherapy With Interleukin-2 and Granulocyte-Macrophage Colony Stimulating Factor in Patients With Metastatic Melanoma With a Partial Response or Stable Disease After Systemic Therapy
RATIONALE: Interleukin-2 and sargramostim may stimulate a person's white blood cells to kill melanoma cells. PURPOSE: This phase II trial is studying how well giving interleukin-2 together with sargramostim works in treating patients with stage III or stage IV melanoma that was previously treated with chemotherapy.
OBJECTIVES: Primary * Determine the frequency of complete response in patients with stage III or IV melanoma who have achieved either a partial response or stable disease after prior systemic chemotherapy and are treated with maintenance biotherapy comprising interleukin-2 and sargramostim (GM-CSF). Secondary * Determine the time to progression in patients treated with this regimen. * Determine the effects of this regimen on lymphocyte subsets in these patients. OUTLINE: Patients are stratified according to response to prior systemic chemotherapy (stable disease \[SD\] vs partial response \[PR\]). Patients receive sargramostim (GM-CSF) subcutaneously (SC) on days 1-14 and low-dose interleukin-2 (IL-2) SC on days 1-5, 8-12, 15-19, and 22-26. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. Patients also receive pulses of high-dose IL-2\* IV continuously over 42 hours on days 1 and 2 of courses 2, 3, 5, 6, 8, 10 and 12. NOTE: \*Low-dose IL-2 and GM-CSF are not administered on days 1 and 2 of high-dose IL-2 administration Patients who continue to have SD or a PR after 12 courses of therapy may continue to receive treatment with GM-CSF and low-dose IL-2 as described above and high-dose IL-2 on days 1 and 2 of every third course. PROJECTED ACCRUAL: A total of 20-58 patients (10-29 per stratum) will be accrued for this study.
Age
16 - No limit years
Sex
ALL
Healthy Volunteers
No
Memorial Sloan-Kettering Cancer Center
New York, New York, United States
Start Date
March 1, 2004
Primary Completion Date
March 1, 2005
Completion Date
March 1, 2005
Last Updated
December 12, 2012
aldesleukin
BIOLOGICAL
sargramostim
BIOLOGICAL
adjuvant therapy
PROCEDURE
Lead Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
NCT04079166
NCT04911998
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