Interleukin-21 in Treating Patients With Metastatic or Recurrent Malignant Melanoma
- Conditions
- Melanoma (Skin)
- Interventions
- Biological: recombinant human interleukin-21Other: immunohistochemistry staining methodOther: laboratory biomarker analysisOther: pharmacological study
- Registration Number
- NCT00514085
- Lead Sponsor
- NCIC Clinical Trials Group
- Brief Summary
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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Recombinant human interleukin-21 immunohistochemistry staining method - Recombinant human interleukin-21 recombinant human interleukin-21 - Recombinant human interleukin-21 laboratory biomarker analysis - Recombinant human interleukin-21 pharmacological study -
- Primary Outcome Measures
Name Time Method Objective tumor response as assessed by RECIST after completion of treatment Overall response rate (complete and partial) after completion of study Stable disease rate after completion of study Median time to progression after completion of study Progressive disease rate after completion of study Response duration (median and range) after completion of study
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (7)
Cross Cancer Institute
🇨🇦Edmonton, Alberta, Canada
CancerCare Manitoba
🇨🇦Winnipeg, Manitoba, Canada
BCCA - Fraser Valley Cancer Centre
🇨🇦Surrey, British Columbia, Canada
Juravinski Cancer Centre at Hamilton Health Sciences
🇨🇦Hamilton, Ontario, Canada
Odette Cancer Centre
🇨🇦Toronto, Ontario, Canada
CHUM - Hopital Notre-Dame
🇨🇦Montreal, Quebec, Canada
BCCA - Vancouver Cancer Centre
🇨🇦Vancouver, British Columbia, Canada