Expired Study
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New York, New York 10021


Purpose:

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.


Study summary:

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.


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


NCT ID:

NCT00085579


Primary Contact:

Principal Investigator
Paul B. Chapman, MD
Memorial Sloan-Kettering Cancer Center


Backup Contact:

N/A


Location Contact:

New York, New York 10021
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: December 12, 2017

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