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Sponsors and Collaborators: |
Memorial Sloan-Kettering Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00085579 |
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.
Condition | Intervention | Phase |
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Melanoma (Skin) |
Drug: aldesleukin Drug: sargramostim Procedure: adjuvant therapy |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | 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 |
Study Start Date: | March 2004 |
OBJECTIVES:
Primary
Secondary
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.
Ages Eligible for Study: | 16 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed melanoma
Stable disease (SD) or partial response (PR) after prior systemic chemotherapy completed at least 4 weeks ago
Patients whose second evaluation shows disease progression are eligible unless one of the following is true:
No active CNS metastases
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Patients ≥ 50 years of age OR those with one or more cardiac risk factors must demonstrate one of the following:
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
United States, New York | |
Memorial Sloan-Kettering Cancer Center | |
New York, New York, United States, 10021 |
Principal Investigator: | Paul B. Chapman, MD | Memorial Sloan-Kettering Cancer Center |
Principal Investigator: | Jedd D. Wolchok, MD | Memorial Sloan-Kettering Cancer Center |
Study ID Numbers: | CDR0000370827, MSKCC-04027 |
Study First Received: | June 10, 2004 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00085579 |
Health Authority: | United States: Federal Government |
stage III melanoma stage IV melanoma |
Neuroectodermal Tumors Aldesleukin Interleukin-2 Nevus, Pigmented Neoplasms, Germ Cell and Embryonal |
Neuroepithelioma Nevus Neuroendocrine Tumors Melanoma |
Anti-Infective Agents Anti-HIV Agents Neoplasms by Histologic Type Antineoplastic Agents Neoplasms, Nerve Tissue Physiological Effects of Drugs Antiviral Agents Pharmacologic Actions Neoplasms |
Anti-Retroviral Agents Analgesics, Non-Narcotic Sensory System Agents Therapeutic Uses Nevi and Melanomas Analgesics Peripheral Nervous System Agents Central Nervous System Agents |