Suspended

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

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What is being tested

Data Collection

Who is being recruted

Melanoma
+8

+ Neoplasms
+ Neoplasms by Histologic Type
Over 16 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: March 2004
See protocol details

Summary

Principal SponsorMemorial Sloan Kettering Cancer Center
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner
Study start date: March 1, 2004Actual date on which the first participant was enrolled.

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 TitleA 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 
NCT00085579
Principal SponsorMemorial Sloan Kettering Cancer Center
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind
: Participants do not know which treatment they are receiving, but researchers do.

Double-blind
: Neither participants nor researchers know which treatment is given.

Triple-blind
: Participants, researchers, and outcome assessors do not know which treatment is given.

Quadruple-blind
: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Over 16 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Melanoma
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Skin Diseases
Skin Neoplasms
Neuroectodermal Tumors
Nevi and Melanomas
Neuroendocrine Tumors
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



Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 1 location
Suspended
Memorial Sloan-Kettering Cancer CenterNew York, United StatesSee the location

SuspendedOne Study Center
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