Interleukin-2 and Sargramostim After Chemotherapy in Treating Patients With Stage III or Stage IV Melanoma
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|ClinicalTrials.gov Identifier: NCT00085579|
Recruitment Status : Withdrawn
First Posted : June 11, 2004
Last Update Posted : December 12, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Melanoma (Skin)||Biological: aldesleukin Biological: sargramostim Procedure: adjuvant therapy||Phase 2|
- 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).
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||March 2004|
|Primary Completion Date :||March 2005|
|Study Completion Date :||March 2005|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00085579
|United States, New York|
|Memorial Sloan-Kettering Cancer Center|
|New York, New York, United States, 10021|
|Principal Investigator:||Paul B. Chapman, MD||Memorial Sloan Kettering Cancer Center|
|Principal Investigator:||Jedd D. Wolchok, MD||Memorial Sloan Kettering Cancer Center|