Ignite Creation Date:
2024-05-05 @ 11:34 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00074230
Status:
COMPLETED
Last Update Posted:
2015-05-12
First Post:
2003-12-10
Brief Title:
Vaccine Therapy in Treating Patients With Stage IV Cutaneous Melanoma
Sponsor:
University Hospital Erlangen
Organization:
University Hospital Erlangen
Study Overview
Official Title:
Vaccination of Stage IV Cutaneous Melanoma Patients With Mature Autologous Monocyte-Derived Dendritic Cells Transfected With RNAs Encoding for Mage-3 MelanA and Survivin Antigens
Status:
COMPLETED
Status Verified Date:
2015-05
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 Vaccines made from a persons dendritic cells and antigens may make the body build an immune response to kill tumor cells
PURPOSE Phase III trial to study the effectiveness of vaccine therapy using autologous dendritic cells with antigens in treating patients who have stage IV cutaneous melanoma
PURPOSE Phase III trial to study the effectiveness of vaccine therapy using autologous dendritic cells with antigens in treating patients who have stage IV cutaneous melanoma
Detailed Description:
OBJECTIVES
Primary
Determine the safety and tolerability of vaccination with autologous monocyte-derived dendritic cells DC transfected with RNAs encoding Melan-A MAGE-3 and survivin antigens in patients with stage IV cutaneous melanoma
Determine whether tumor antigen-specific T-cell responses are induced in patients treated with this vaccine
Determine whether simultaneous loading of DC with keyhole limpet hemocyanin KLH significantly enhances induction of the Melan-A MAGE-3 and survivin antigens in these patients
Secondary
Determine clinical antitumor activity eg objective tumor response time to tumor progression progression-free interval and overall survival in patients treated with this vaccine
OUTLINE This is an open-label nonrandomized study
Phase I Beginning 9-11 days before vaccination patients undergo leukapheresis for collection of peripheral blood mononuclear cells PBMCs PBMCs are processed for the generation of dendritic cells DC to be used for vaccinations PBMCs are transfected with RNAs encoding for Melan-A MAGE-3 and survivin antigens DC are pulsed with keyhole limpet hemocyanin KLH for some patients
Patients receive antigen-pulsed with or without KLH DC vaccination subcutaneously SC on days 1 15 43 and 71 in the absence of disease progression or unacceptable toxicity Patients with stable or responding disease may proceed to the phase II portion of the study
Phase II Patients undergo leukapheresis as in phase I on days 102 354 and 690 Patients receive up to 6 additional booster vaccinations SC as in phase I on days 127 185 269 356 521 and 692
Patients are followed for 10 years
PROJECTED ACCRUAL A total of 8-30 patients will be accrued for this study within 6-12 months
Primary
Determine the safety and tolerability of vaccination with autologous monocyte-derived dendritic cells DC transfected with RNAs encoding Melan-A MAGE-3 and survivin antigens in patients with stage IV cutaneous melanoma
Determine whether tumor antigen-specific T-cell responses are induced in patients treated with this vaccine
Determine whether simultaneous loading of DC with keyhole limpet hemocyanin KLH significantly enhances induction of the Melan-A MAGE-3 and survivin antigens in these patients
Secondary
Determine clinical antitumor activity eg objective tumor response time to tumor progression progression-free interval and overall survival in patients treated with this vaccine
OUTLINE This is an open-label nonrandomized study
Phase I Beginning 9-11 days before vaccination patients undergo leukapheresis for collection of peripheral blood mononuclear cells PBMCs PBMCs are processed for the generation of dendritic cells DC to be used for vaccinations PBMCs are transfected with RNAs encoding for Melan-A MAGE-3 and survivin antigens DC are pulsed with keyhole limpet hemocyanin KLH for some patients
Patients receive antigen-pulsed with or without KLH DC vaccination subcutaneously SC on days 1 15 43 and 71 in the absence of disease progression or unacceptable toxicity Patients with stable or responding disease may proceed to the phase II portion of the study
Phase II Patients undergo leukapheresis as in phase I on days 102 354 and 690 Patients receive up to 6 additional booster vaccinations SC as in phase I on days 127 185 269 356 521 and 692
Patients are followed for 10 years
PROJECTED ACCRUAL A total of 8-30 patients will be accrued for this study within 6-12 months
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 |
|---|---|---|---|
| EU-20317 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000343699 | REGISTRY | None | None |