Interleukin-21 in Treating 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.
Biological: recombinant human interleukin-21
Other: immunohistochemistry staining method
Other: laboratory biomarker analysis
Other: pharmacological study
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Study of Interleukin-21 (IL-21) in Patients With Metastatic or Recurrent Malignant Melanoma|
- 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 ]
|Study Start Date:||July 2007|
|Study Completion Date:||July 2012|
|Primary Completion Date:||September 2010 (Final data collection date for primary outcome measure)|
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
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00514085
|Cross Cancer Institute|
|Edmonton, Alberta, Canada, T6G 1Z2|
|Canada, British Columbia|
|BCCA - Fraser Valley Cancer Centre|
|Surrey, British Columbia, Canada, V3V 1Z2|
|BCCA - Vancouver Cancer Centre|
|Vancouver, British Columbia, Canada, V5Z 4E6|
|Winnipeg, Manitoba, Canada, R3E 0V9|
|Juravinski Cancer Centre at Hamilton Health Sciences|
|Hamilton, Ontario, Canada, L8V 5C2|
|Odette Cancer Centre|
|Toronto, Ontario, Canada, M4N 3M5|
|CHUM - Hopital Notre-Dame|
|Montreal, Quebec, Canada, H2L 4M1|
|Study Chair:||Teresa M. Petrella||Toronto Sunnybrook Regional Cancer Centre|