Interleukin-2 and Sargramostim After Chemotherapy in Treating Patients With Stage III or Stage IV Melanoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00085579
Recruitment Status : Withdrawn
First Posted : June 11, 2004
Last Update Posted : December 12, 2012
National Cancer Institute (NCI)
Information provided by:
Memorial Sloan Kettering Cancer Center

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.

Condition or disease Intervention/treatment Phase
Melanoma (Skin) Biological: aldesleukin Biological: sargramostim Procedure: adjuvant therapy Phase 2

Detailed Description:



  • 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).


  • 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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Primary Completion Date : March 2005
Actual Study Completion Date : March 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Melanoma

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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



  • 16 and over

Performance status

  • Karnofsky 60-100%

Life expectancy

  • Not specified


  • WBC ≥ 3,000/mm^3
  • Platelet count ≥ 100,000/mm^3
  • No active bleeding


  • See Disease Characteristics
  • Bilirubin ≤ 2.0 mg/dL


  • Creatinine ≤ 1.2 mg/dL


  • 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%


  • 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


Biologic therapy

  • No other concurrent antineoplastic biologic response modifier therapy
  • No concurrent antineoplastic vaccine therapy


  • See Disease Characteristics
  • No concurrent antineoplastic chemotherapy

Endocrine therapy

  • No concurrent steroidal antiemetics
  • No concurrent systemic corticosteroids


  • See Disease Characteristics
  • No concurrent antineoplastic radiotherapy


  • See Disease Characteristics
  • Recovered from prior surgery
  • Surgery within the past 4 weeks allowed provided there is no evidence of disease progression


  • More than 4 weeks since prior therapy for melanoma
  • No other concurrent antineoplastic experimental therapy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00085579

United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
National Cancer Institute (NCI)
Principal Investigator: Paul B. Chapman, MD Memorial Sloan Kettering Cancer Center
Principal Investigator: Jedd D. Wolchok, MD Memorial Sloan Kettering Cancer Center Identifier: NCT00085579     History of Changes
Other Study ID Numbers: 04-027
First Posted: June 11, 2004    Key Record Dates
Last Update Posted: December 12, 2012
Last Verified: December 2012

Keywords provided by Memorial Sloan Kettering Cancer Center:
stage III melanoma
stage IV melanoma

Additional relevant MeSH terms:
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas
Antineoplastic Agents
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents