Interleukin-21 in Treating Patients With Metastatic or Recurrent Malignant Melanoma
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|ClinicalTrials.gov Identifier: NCT00514085|
Recruitment Status : Completed
First Posted : August 9, 2007
Last Update Posted : November 28, 2016
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 or disease||Intervention/treatment||Phase|
|Melanoma (Skin)||Biological: recombinant human interleukin-21 Other: immunohistochemistry staining method Other: laboratory biomarker analysis Other: pharmacological study||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Interleukin-21 (IL-21) in Patients With Metastatic or Recurrent Malignant Melanoma|
|Study Start Date :||July 2007|
|Actual Primary Completion Date :||September 2010|
|Actual Study Completion Date :||July 2012|
- 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
- Objective tumor response as assessed by RECIST [ Time Frame: after completion of treatment ]
- Overall response rate (complete and partial) [ Time Frame: after completion of study ]
- Stable disease rate [ Time Frame: after completion of study ]
- Progressive disease rate [ Time Frame: after completion of study ]
- Median time to progression [ Time Frame: after completion of study ]
- Response duration (median and range) [ Time Frame: after completion of study ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|