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This study has been withdrawn prior to enrollment.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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Neuroectodermal Tumors
Neuroendocrine Tumors
Nevi and Melanomas
Interleukin-2
Analgesics
Analgesics, Non-Narcotic
Antineoplastic Agents
Central Nervous System Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014