Melanoma (Skin)
Conditions
Keywords
stage III melanoma, stage IV melanoma
Brief 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.
Interventions
BIOLOGICALaldesleukin
BIOLOGICALsargramostim
PROCEDUREadjuvant therapy
Sponsors
National Cancer Institute (NCI)
Memorial Sloan Kettering Cancer Center
Study design
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
Inclusion 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
Countries
United States
Outcome results
None listed