NCT00085579

Interleukin-2 and Sargramostim After Chemotherapy in Treating Patients With Stage III or Stage IV Melanoma

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

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Memorial Sloan Kettering Cancer Center · Academic / Other
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Melanoma (Skin)

Interventions

Type	Name	Description
BIOLOGICAL	aldesleukin
BIOLOGICAL	sargramostim
PROCEDURE	adjuvant therapy

Timeline

• Start date: 2004-03-01
• Primary completion: 2005-03-01
• Completion: 2005-03-01
• First posted: 2004-06-11
• Last updated: 2012-12-12

Locations

1 site across 1 country: United States