Ignite Creation Date:
2024-05-05 @ 9:14 PM
Last Modification Date:
2024-10-26 @ 10:01 AM
Study NCT ID:
NCT00847106
Status:
COMPLETED
Last Update Posted:
2009-02-19
First Post:
2009-02-18
Brief Title:
Augmentation of Dendritic Cell-Based Vaccines in Melanoma Patients by Depletion of Regulatory T Cells in Stage IV Melanoma Patients
Sponsor:
Radboud University Medical Center
Organization:
Radboud University Medical Center
Study Overview
Official Title:
Augmentation of Dendritic Cell Based Vaccines in Melanoma Patients by Depletion of Regulatory T Cells With an Anti-CD25 Monoclonal Antibody Daclizumab A Clinical Study
Status:
COMPLETED
Status Verified Date:
2009-02
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:
Dendritic cells DC are the professional antigen presenting cells of the immune system Multiple distinct DC lineages exist and it is now well appreciated that the DC subset and the maturation stage of the DC determines the type of immune response ranging from a TH1 or TH2 response to immune tolerance The extremely potent capacity of mature DC to initiate immune responses can be exploited to fight infectious diseases and cancer Others and we are currently using tumor antigen loaded mature DC in clinical vaccination studies against cancer and clinical as well as immunological responses have been observed
Exciting new insights accompany the revival of suppressor T cells now referred to as regulatory T cells Treg and implicate that also Treg play a key role in the control of immunity Treg constitute a sub-population of CD4 T cells constitutively expressing the IL-2R alpha-chain CD25 Treg show remarkably suppressive activities on different components of the immune system including T lymphocytes and dendritic cells suggesting they act both at the initiation phase DC and at the effector phase activated T cells of the immune response Interestingly temporal depletion of Treg has been shown to enhance anti-tumor immune responses and in case of prolonged absence of Treg even autoimmunity Furthermore data in mouse tumor models indicate that temporal depletion of Treg also results in improved vaccine efficiency in the therapeutic setting eg in mice with a pre-existing tumor These data imply that in tumor bearing patients depletion of Treg prior to vaccination will improve vaccine efficacy
In this study we investigate the effect of regulatory T cell Treg depletion on the efficacy of DC-based anti-tumor vaccines in a clinical study using melanoma associated antigens tyrosinase and gp100-loaded DC and a depleting anti-CD25 mononuclear antibody Daclizumab Our primary objective in this study is the induction of an effective anti-tumor immune response Our secondary objective is the induction of a clinical response
Exciting new insights accompany the revival of suppressor T cells now referred to as regulatory T cells Treg and implicate that also Treg play a key role in the control of immunity Treg constitute a sub-population of CD4 T cells constitutively expressing the IL-2R alpha-chain CD25 Treg show remarkably suppressive activities on different components of the immune system including T lymphocytes and dendritic cells suggesting they act both at the initiation phase DC and at the effector phase activated T cells of the immune response Interestingly temporal depletion of Treg has been shown to enhance anti-tumor immune responses and in case of prolonged absence of Treg even autoimmunity Furthermore data in mouse tumor models indicate that temporal depletion of Treg also results in improved vaccine efficiency in the therapeutic setting eg in mice with a pre-existing tumor These data imply that in tumor bearing patients depletion of Treg prior to vaccination will improve vaccine efficacy
In this study we investigate the effect of regulatory T cell Treg depletion on the efficacy of DC-based anti-tumor vaccines in a clinical study using melanoma associated antigens tyrosinase and gp100-loaded DC and a depleting anti-CD25 mononuclear antibody Daclizumab Our primary objective in this study is the induction of an effective anti-tumor immune response Our secondary objective is the induction of a clinical response
Detailed Description:
None
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 |
|---|---|---|---|
| KWF 2003-2893 | None | None | None |