Full Text View
Tabular View
No Study Results Posted
Related Studies
Interleukin-21 in Treating Patients With Metastatic or Recurrent Malignant Melanoma
This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), May 2008
First Received: August 8, 2007   Last Updated: February 6, 2009   History of Changes
Sponsored by: National Cancer Institute of Canada
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00514085
  Purpose

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.


Condition Intervention Phase
Melanoma (Skin)
Biological: recombinant human interleukin-21
Other: immunohistochemistry staining method
Other: laboratory biomarker analysis
Other: pharmacological study
Phase II

MedlinePlus related topics: Cancer Melanoma
Drug Information available for: Interleukin-21
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: A Phase II Study of Interleukin-21 (IL-21) in Patients With Metastatic or Recurrent Malignant Melanoma

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Objective tumor response as assessed by RECIST [ Designated as safety issue: No ]
  • Overall response rate (complete and partial) [ Designated as safety issue: No ]
  • Stable disease rate [ Designated as safety issue: No ]
  • Progressive disease rate [ Designated as safety issue: No ]
  • Median time to progression [ Designated as safety issue: No ]
  • Response duration (median and range) [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: July 2007
Estimated Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

Primary

  • 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.

Secondary

  • 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

  • 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

PRIOR CONCURRENT THERAPY:

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00514085

Locations
Canada, Alberta
Cross Cancer Institute at University of Alberta Recruiting
Edmonton, Alberta, Canada, T6G 1Z2
Contact: Michael Smylie     780-432-8757        
Canada, British Columbia
BCCA - Fraser Valley Cancer Centre Recruiting
Surrey, British Columbia, Canada, V3V 1Z2
Contact: Gary K. Pansegrau     604-930-4064        
British Columbia Cancer Agency - Vancouver Cancer Centre Recruiting
Vancouver, British Columbia, Canada, V5Z 4E6
Contact: Kerry J. Savage     604-877-6000        
Canada, Manitoba
CancerCare Manitoba Recruiting
Winnipeg, Manitoba, Canada, R3E 0V9
Contact: Ralph P.W. Wong     204-237-2006        
Canada, Ontario
Edmond Odette Cancer Centre at Sunnybrook Recruiting
Toronto, Ontario, Canada, M4N 3M5
Contact: Teresa M. Petrella     416-480-5248        
Margaret and Charles Juravinski Cancer Centre Recruiting
Hamilton, Ontario, Canada, L8V 5C2
Contact: Richard G. Tozer     905-387-9495        
Canada, Quebec
Hopital Notre-Dame du CHUM Recruiting
Montreal, Quebec, Canada, H2L 4M1
Contact: Karl Belanger     514-890-8200        
Sponsors and Collaborators
National Cancer Institute of Canada
Investigators
Study Chair: Teresa M. Petrella Edmond Odette Cancer Centre at Sunnybrook
  More Information

Additional Information:
No publications provided

Study ID Numbers: CDR0000560973, CAN-NCIC-IND189, IND.189, ZYMOGENETICS-CAN-NCIC-IND189
Study First Received: August 8, 2007
Last Updated: February 6, 2009
ClinicalTrials.gov Identifier: NCT00514085     History of Changes
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
recurrent melanoma
stage IV melanoma

Study placed in the following topic categories:
Neuroectodermal Tumors
Nevus, Pigmented
Neoplasms, Germ Cell and Embryonal
Neuroepithelioma
Nevus
Recurrence
Neuroendocrine Tumors
Melanoma

Additional relevant MeSH terms:
Neuroectodermal Tumors
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Nevi and Melanomas
Neuroendocrine Tumors
Melanoma

ClinicalTrials.gov processed this record on May 07, 2009