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

This study has been withdrawn prior to enrollment.
Sponsor:
Collaborator:
Information provided by:
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00085579
First received: June 10, 2004
Last updated: December 11, 2012
Last verified: December 2012
  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.


Condition Intervention Phase
Melanoma (Skin)
Biological: aldesleukin
Biological: sargramostim
Procedure: adjuvant therapy
Phase 2

Study Type: Interventional
Study Design: Masking: 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

Resource links provided by NLM:


Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Enrollment: 0
Study Start Date: March 2004
Study Completion Date: March 2005
Primary Completion Date: March 2005 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00085579

Locations
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Investigators
Principal Investigator: Paul B. Chapman, MD Memorial Sloan-Kettering Cancer Center
Principal Investigator: Jedd D. Wolchok, MD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00085579     History of Changes
Other Study ID Numbers: 04-027, MSKCC-04027
Study First Received: June 10, 2004
Last Updated: December 11, 2012
Health Authority: United States: Federal Government

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

Additional relevant MeSH terms:
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Aldesleukin
Interleukin-2
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on April 21, 2014