Ignite Creation Date:
2024-05-05 @ 11:45 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00126685
Status:
UNKNOWN
Last Update Posted:
2013-09-17
First Post:
2005-08-03
Brief Title:
Vaccine Therapy in Treating Patients With Stage IV Melanoma
Sponsor:
Dermatologische Klinik MIT Poliklinik-Universitaetsklinikum Erlangen
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Vaccination of Stage IV Cutaneous Melanoma Patients With Mature Autologous Monocyte-Derived Dendritic Cells Transfected With Unselected Autologous Amplified Tumor-RNA
Status:
UNKNOWN
Status Verified Date:
2007-06
Last Known Status:
ACTIVE_NOT_RECRUITING
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 tumor cells and white blood cells may help the body build an effective immune response to kill tumor cells
PURPOSE This phase III trial is studying the side effects of vaccine therapy and to see how well it works in treating patients with stage IV melanoma
PURPOSE This phase III trial is studying the side effects of vaccine therapy and to see how well it works in treating patients with stage IV melanoma
Detailed Description:
OBJECTIVES
Determine the safety and tolerability of vaccine therapy comprising autologous dendritic cells DC transfected with autologous polymerase chain reaction-amplified tumor RNA in patients with stage IV cutaneous melanoma
Determine whether tumor RNA- or tumor antigen-specific T-cell responses are induced in patients treated with this vaccine
Determine whether there are major differences in the immunogenicity of DC transfected at immature stage or at mature stage in patients treated with this vaccine
Determine objective tumor response in patients treated with this vaccine
Determine time to disease progression and progression-free interval in patients treated with this vaccine
Determine overall survival of patients treated with this vaccine
OUTLINE This is an open-label nonrandomized study Patients are sequentially assigned to receive dendritic cells DC transfected at either immature or mature stage
Approximately 2-3 weeks before leukapheresis patients undergo surgical excision or biopsy of the tumor to obtain tumor tissue for RNA isolation RNA is amplified from the tumor sample by polymerase chain reaction PCR Patients then undergo leukapheresis to harvest peripheral blood mononuclear cells for the production of DC on day -14 DC at immature or mature stage are transfected with autologous PCR-amplified tumor RNA to produce the vaccine Patients receive vaccine intradermally ID on days 1 15 29 43 57 and between days 71-74 in the absence of disease progression or unacceptable toxicity Patients undergo evaluation between days 71-74 Patients with responding or stable disease or minor disease progression receive booster vaccine ID on days 99 127 between days 162-164 on day 205 between days 253-255 351-354 442-444 533-535 624-626 and 715-718 in the absence of disease progression or unacceptable toxicity Patients also undergo additional leukapheresis between days 71-74 351-354 and 715-718 Patients with responding or stable disease may continue to undergo leukapheresis and receive booster vaccine ID every 12-24 weeks off study
After completion of study treatment patients are followed periodically for up to 10 years
PROJECTED ACCRUAL A total of 8-30 patients will be accrued for this study within 6-12 months
Determine the safety and tolerability of vaccine therapy comprising autologous dendritic cells DC transfected with autologous polymerase chain reaction-amplified tumor RNA in patients with stage IV cutaneous melanoma
Determine whether tumor RNA- or tumor antigen-specific T-cell responses are induced in patients treated with this vaccine
Determine whether there are major differences in the immunogenicity of DC transfected at immature stage or at mature stage in patients treated with this vaccine
Determine objective tumor response in patients treated with this vaccine
Determine time to disease progression and progression-free interval in patients treated with this vaccine
Determine overall survival of patients treated with this vaccine
OUTLINE This is an open-label nonrandomized study Patients are sequentially assigned to receive dendritic cells DC transfected at either immature or mature stage
Approximately 2-3 weeks before leukapheresis patients undergo surgical excision or biopsy of the tumor to obtain tumor tissue for RNA isolation RNA is amplified from the tumor sample by polymerase chain reaction PCR Patients then undergo leukapheresis to harvest peripheral blood mononuclear cells for the production of DC on day -14 DC at immature or mature stage are transfected with autologous PCR-amplified tumor RNA to produce the vaccine Patients receive vaccine intradermally ID on days 1 15 29 43 57 and between days 71-74 in the absence of disease progression or unacceptable toxicity Patients undergo evaluation between days 71-74 Patients with responding or stable disease or minor disease progression receive booster vaccine ID on days 99 127 between days 162-164 on day 205 between days 253-255 351-354 442-444 533-535 624-626 and 715-718 in the absence of disease progression or unacceptable toxicity Patients also undergo additional leukapheresis between days 71-74 351-354 and 715-718 Patients with responding or stable disease may continue to undergo leukapheresis and receive booster vaccine ID every 12-24 weeks off study
After completion of study treatment patients are followed periodically for up to 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:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| ERLANGEN-DERMA-ER-DC-07 | None | None | None |
| EU-20513 | None | None | None |
| ARGOS-ERLANGEN-DERMA-DC-07 | None | None | None |