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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Melanoma (Skin)

Intervention / Treatment
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* Biological: aldesleukin
* Biological: sargramostim
* Procedure: adjuvant therapy


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically confirmed melanoma Stage III or IV disease No primary ocular melanoma Stable disease (SD) or partial response (PR) after prior systemic chemotherapy completed at least 4 weeks ago Patients whose second post-chemotherapy evaluation (performed at least 4 weeks after the first evaluation that demonstrated SD or PR AND within 2 weeks before study entry) of disease demonstrates continued tumor shrinkage are not eligible Patients whose second evaluation shows disease progression are eligible unless one of the following is true: Lactic dehydrogenase (LDH) ≥ 2 times upper limit of normal (ULN) LDH > ULN AND is higher than the patient's highest value before systemic chemotherapy Patient has developed a new tumor measuring > 1 cm in diameter Sum of the longest diameters of the existing tumor has increased > 20% Evaluable or measurable disease Not potentially curable by surgery No active CNS metastases Solitary brain metastasis allowed if completely resected or completely ablated with radiosurgery more than 1 month before study entry PATIENT CHARACTERISTICS: Age 16 and over Performance status Karnofsky 60-100% Life expectancy Not specified Hematopoietic WBC ≥ 3,000/mm^3 Platelet count ≥ 100,000/mm^3 No active bleeding Hepatic See Disease Characteristics Bilirubin ≤ 2.0 mg/dL Renal Creatinine ≤ 1.2 mg/dL Cardiovascular Patients ≥ 50 years of age OR those with one or more cardiac risk factors must demonstrate one of the following: Normal exercise stress test Normal stress thallium test Normal comparable cardiac ischemia evaluation LVEF ≥ 40% Other No active infection requiring treatment No concurrent medical or psychiatric condition that would increase the potential toxicity of study treatment Not pregnant or nursing Negative pregnancy test Fertile patients must use effective barrier contraception PRIOR CONCURRENT THERAPY: Biologic therapy No other concurrent antineoplastic biologic response modifier therapy No concurrent antineoplastic vaccine therapy Chemotherapy See Disease Characteristics No concurrent antineoplastic chemotherapy Endocrine therapy No concurrent steroidal antiemetics No concurrent systemic corticosteroids Radiotherapy See Disease Characteristics No concurrent antineoplastic radiotherapy Surgery See Disease Characteristics Recovered from prior surgery Surgery within the past 4 weeks allowed provided there is no evidence of disease progression Other More than 4 weeks since prior therapy for melanoma No other concurrent antineoplastic experimental therapy

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: aldesleukin|nan|
|Biological: sargramostim|nan|
|Procedure: adjuvant therapy|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage III melanoma, stage IV melanoma