interleukin-2 and sargramostim after chemotherapy in treating patients with stage iii or stage iv melanoma

Conditions: Melanoma (Skin)

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.

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.

Eligibility criteria:
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

Keywords: stage iii melanoma stage iv melanoma