Ignite Creation Date:
2024-05-05 @ 6:36 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00514085
Status:
COMPLETED
Last Update Posted:
2023-08-04
First Post:
2007-08-08
Brief Title:
Interleukin-21 in Treating Patients With Metastatic or Recurrent Malignant Melanoma
Sponsor:
NCIC Clinical Trials Group
Organization:
Canadian Cancer Trials Group
Study Overview
Official Title:
A Phase II Study of Interleukin-21 IL-21 in Patients With Metastatic or Recurrent Malignant Melanoma
Status:
COMPLETED
Status Verified Date:
2020-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CAN-NCIC-IND189 | REGISTRY | None | None |
| IND189 | OTHER | None | None |
| ZYMOGENETICS-CAN-NCIC-IND189 | OTHER | None | None |
| CDR0000560973 | OTHER | PDQ | None |