Ignite Creation Date:
2024-05-06 @ 1:06 AM
Last Modification Date:
2024-10-26 @ 10:59 AM
Study NCT ID:
NCT01727076
Status:
COMPLETED
Last Update Posted:
2017-09-15
First Post:
2012-11-12
Brief Title:
Recombinant Interleukin-15 in Treating Patients With Advanced Melanoma Kidney Cancer Non-small Cell Lung Cancer or Squamous Cell Head and Neck Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase 1 Study of Recombinant Human IL15 rhIL15 in Adults With Advanced Solid Tumors Melanoma Renal Cell Non-Small Cell Lung and Squamous Cell Head and Neck Cancer
Status:
COMPLETED
Status Verified Date:
2017-09
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:
This phase I trial studies the side effects and best dose of recombinant interleukin-15 in treating patients with melanoma kidney cancer non-small cell lung cancer or head and neck cancer that has spread to other places in the body and usually cannot be cured or controlled with treatment Recombinant interleukin-IL15 is a biological product a protein made naturally in the body and when made in the laboratory may help stimulate the immune system in different ways and stop tumor cells from growing
Detailed Description:
PRIMARY OBJECTIVES
I To determine the maximum tolerated dose MTD of recombinant human IL15 rhIL15 administered subcutaneously
SECONDARY OBJECTIVES
I To determine the effect of the dose schedules of rhIL15 on the number and phenotype of peripheral blood mononuclear cells including total white blood cell count absolute lymphocyte count ALC and total number of T cells and natural killer NK cells as well as activated T cells T cell subsets and NK cell subsets
II To determine the effects of the dose schedules of rhIL15 on the function of peripheral blood mononuclear cells including T cell subset response to recall viral antigens including cytomegalovirus CMV and influenza A virus T cell responses to non-physiologic stimuli including phytohemagglutinin PHA and NK cell cytokine interferon gamma IFN-y secretion and degranulation by cluster of differentiation 107a CD107a expression
III To assess tumor response rate by objective response rate ORR IV To assess the immunogenicity pharmacokinetic PK and pharmacodynamic PD profiles of National Cancer Institute NCI rhIL15
OUTLINE This is a dose-escalation study
Patients receive recombinant interleukin-15 subcutaneously SC daily on days 1-5 of weeks 1 and 2 Treatment repeats every 28 days 4 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up for 24 weeks
I To determine the maximum tolerated dose MTD of recombinant human IL15 rhIL15 administered subcutaneously
SECONDARY OBJECTIVES
I To determine the effect of the dose schedules of rhIL15 on the number and phenotype of peripheral blood mononuclear cells including total white blood cell count absolute lymphocyte count ALC and total number of T cells and natural killer NK cells as well as activated T cells T cell subsets and NK cell subsets
II To determine the effects of the dose schedules of rhIL15 on the function of peripheral blood mononuclear cells including T cell subset response to recall viral antigens including cytomegalovirus CMV and influenza A virus T cell responses to non-physiologic stimuli including phytohemagglutinin PHA and NK cell cytokine interferon gamma IFN-y secretion and degranulation by cluster of differentiation 107a CD107a expression
III To assess tumor response rate by objective response rate ORR IV To assess the immunogenicity pharmacokinetic PK and pharmacodynamic PD profiles of National Cancer Institute NCI rhIL15
OUTLINE This is a dose-escalation study
Patients receive recombinant interleukin-15 subcutaneously SC daily on days 1-5 of weeks 1 and 2 Treatment repeats every 28 days 4 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up for 24 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 |
|---|---|---|---|
| U01CA154967 | NIH | CTEP | httpsreporternihgovquickSearchU01CA154967 |
| NCI-2012-02205 | REGISTRY | None | None |
| CITN11-02 | None | None | None |
| CITN11-02 | OTHER | None | None |
| CITN11-02 | OTHER | None | None |