Melanoma (Skin) Clinical Trial
Official title:
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.
;
Masking: Open Label, Primary Purpose: Treatment
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