Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Interleukin-21 in Treating Patients With Metastatic or Recurrent Malignant Melanoma

This study has been completed.
Information provided by (Responsible Party):
NCIC Clinical Trials Group Identifier:
First received: August 8, 2007
Last updated: July 5, 2012
Last verified: July 2012

August 8, 2007
July 5, 2012
July 2007
September 2010   (final data collection date for primary outcome measure)
  • Objective tumor response as assessed by RECIST [ Time Frame: after completion of treatment ] [ Designated as safety issue: No ]
  • Overall response rate (complete and partial) [ Time Frame: after completion of study ] [ Designated as safety issue: No ]
  • Stable disease rate [ Time Frame: after completion of study ] [ Designated as safety issue: No ]
  • Progressive disease rate [ Time Frame: after completion of study ] [ Designated as safety issue: No ]
  • Median time to progression [ Time Frame: after completion of study ] [ Designated as safety issue: No ]
  • Response duration (median and range) [ Time Frame: after completion of study ] [ Designated as safety issue: No ]
  • Objective tumor response as assessed by RECIST criteria
  • Overall response (complete and partial) rate
  • Stable disease rate
  • Progressive disease rate
  • Median time to progression
  • Response duration (median and range)
Complete list of historical versions of study NCT00514085 on Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
Interleukin-21 in Treating Patients With Metastatic or Recurrent Malignant Melanoma
A Phase II Study of Interleukin-21 (IL-21) in Patients With Metastatic or Recurrent Malignant Melanoma

RATIONALE: Interleukin-21 may stimulate white blood cells, including natural killer cells, to kill melanoma cells.

PURPOSE: This phase II trial is studying the side effects and how well interleukin-21 works in treating patients with metastatic or recurrent malignant melanoma.



  • To assess the efficacy, in terms of objective response rate, nonprogression rate, time to progression, and response duration, in patients with metastatic or recurrent malignant melanoma treated with recombinant human interleukin-21 (rIL-21).
  • To assess the toxicity and safety of rIL-21 in patients with previously untreated metastatic or recurrent malignant melanoma.
  • To characterize the pharmacokinetics of rIL-21.
  • To characterize the effects of rIL-21 on lymphocyte cell count and soluble CD25 (sCD25) in serum as potential biomarkers for drug activity.
  • To evaluate the immunogenicity of rIL-21, specifically preexisting immunogenicity to the drug and antibody induction during treatment.
  • To assess melanoma antigenic markers for response and nonprogression on archival tissue from patients enrolled on the study.


  • To investigate whether rIL-21 induced sCD25 release is independent of the level of circulating sCD25.
  • To investigate the effect of rIL-21 on antibody induction during treatment and preexisting immunogenicity.
  • To assess lymphocyte cell-count changes over time in relation to rIL-21 therapy.

OUTLINE: This is a multicenter study.

Patients receive recombinant human interleukin-21 (rIL-21) IV on days 1-5 of weeks 1, 3 and 5. Treatment repeats every 8 weeks in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) or partial response (PR) receive 2 courses beyond CR or PR. Patients with stable disease receive a maximum of 3 courses of rIL-21.

Previously archived tumor tissue and blood samples are collected from patients for correlative studies. Samples are analyzed for soluble CD25, rIL-21 antibodies, circulating lymphocyte counts, preexisting immonogenicity to rIL-21 for antibody induction, and expression of common melanoma tumor antigen markers via IHC.

After completion of study treatment, patients are followed at 4 weeks.

Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Melanoma (Skin)
  • Biological: recombinant human interleukin-21

    Patients enrolled in Part A will receive treatment daily x 5 on weeks 1, 3, and 5 of an 8 week cycle.

    Patients enrolled in Part B will receive treatment daily x 5 on weeks 1, and 3 of a 6 week cycle

  • Other: immunohistochemistry staining method
    Cycle 1 Day 1 and Cycle 1 Day 29
  • Other: laboratory biomarker analysis
    slides will be blocked for 15 minutes in 20% normal goat serum and then incubated in primary antibody
  • Other: pharmacological study
    Starting dose of 50μg/kg/day as an IV push
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
July 2012
September 2010   (final data collection date for primary outcome measure)


  • Histologically confirmed cutaneous malignant melanoma

    • Recurrent or metastatic disease that is not curable by surgical or other means
  • Clinically and/or radiologically documented disease defined as at least one site of disease unidimensionally measurable ≥ 20 mm by x-ray, physical exam, or nonspiral CT scan OR ≥ 10 mm by spiral CT scan
  • Must have nonbulky metastatic disease defined as the largest measurable lesion ≤ 50 mm in maximum diameter
  • Must have primary diagnosis tumor tissue or previously resected metastatic melanoma tissue available (i.e., paraffin block or unstained slides)
  • No known brain metastases


  • ECOG performance status 0-2
  • Life expectancy ≥ 12 weeks
  • Absolute granulocytes count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Bilirubin normal
  • Serum creatinine ≤ 1.5 times upper limit of normal (ULN)
  • AST and ALT ≤ 2.5 times ULN
  • Negative pregnancy test
  • Not pregnant or nursing
  • Fertile patients must use effective contraception during study therapy
  • No uncontrolled intercurrent illness or condition including, but not limited to, any of the following:

    • Ongoing or active infection
    • Symptomatic congestive heart failure
    • Unstable angina pectoris
    • Cardiac arrhythmia
    • Psychiatric illness or social situation that would limit compliance with study requirements
  • No history of hemolysis or a hemolytic disorder including, but not limited to, any of the following:

    • Sickle cell anemia
    • Thalassemia
    • Autoimmune hemolytic anemia
  • No history of other malignancies within the past 5 years except adequately treated nonmelanoma skin cancer, curatively treated carcinoma in situ of the cervix, or other solid tumors curatively treated with no evidence of disease
  • No known HIV, hepatitis B, or hepatitis C infection
  • Patients must reside within a 2-hour drive from a participating center


  • No previous systemic therapy for metastatic disease
  • At least 3 months since prior adjuvant immunotherapy for recurrent melanoma

    • No prior immunotherapy for metastatic disease
    • No prior immunotherapy outside the adjuvant setting
  • At least 4 weeks since prior major surgery
  • At least 4 weeks since prior radiotherapy except low-dose, nonmyelosuppressive radiotherapy and recovered
  • More than 4 weeks since prior and no concurrent investigational agents or anticancer therapy
  • No prior chemotherapy including regional therapy
  • No concurrent systemic corticosteroids (e.g., prednisone or dexamethasone)

    • Concurrent topical steroids are allowed
18 Years and older
Contact information is only displayed when the study is recruiting subjects
NCIC Clinical Trials Group
NCIC Clinical Trials Group
Not Provided
Study Chair: Teresa M. Petrella Edmond Odette Cancer Centre at Sunnybrook
NCIC Clinical Trials Group
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP