Ignite Creation Date:
2024-05-05 @ 11:34 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00085488
Status:
COMPLETED
Last Update Posted:
2015-02-02
First Post:
2004-06-10
Brief Title:
Vaccine Therapy in Treating Patients With Stage III or Stage IV Melanoma
Sponsor:
Dartmouth-Hitchcock Medical Center
Organization:
Dartmouth-Hitchcock Medical Center
Study Overview
Official Title:
En Vivo Matured Dendritic Cell Therapy in Patients With Melanoma
Status:
COMPLETED
Status Verified Date:
2005-10
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 patients dendritic cells and tumor cells may make the body build an immune response to kill tumor cells
PURPOSE This phase I trial is studying the side effects and best dose of vaccine therapy in treating patients with stage III or stage IV melanoma
PURPOSE This phase I trial is studying the side effects and best dose of vaccine therapy in treating patients with stage III or stage IV melanoma
Detailed Description:
OBJECTIVES
Primary
Determine the dose-limiting toxicity and the maximum tolerated dose of autologous dendritic cells pulsed with autologous tumor cell lysate in patients with stage III or IV melanoma
Determine the safety and tolerability of this therapy in these patients
Secondary
Determine the immune response in terms of the type and degree of T-cell proliferation and delayed-type hypersensitivity responses in patients treated with this therapy
OUTLINE This is a dose-escalation pilot study
Patients undergo leukapheresis for the collection of peripheral blood mononuclear cells PBMC on days -9 19 and 47 Autologous dendritic cells DC are prepared from autologous PBMC exposed to sargramostim GM-CSF interleukin-4 and tumor necrosis factor alpha and pulsed with autologous tumor cell lysate Patients receive autologous tumor cell lysate-pulsed DC IV over 5-10 minutes on days 0 28 and 56
Cohorts of 3-6 patients receive escalating doses of autologous tumor cell lysate-pulsed DC until the maximum tolerated dose MTD is determined The MTD is defined as the dose at which 33 of all patients experience dose-limiting toxicity
Patients are followed at day 84 and then every 3 months thereafter
PROJECTED ACCRUAL A total of 3-20 patients will be accrued for this study within 3-20 months
Primary
Determine the dose-limiting toxicity and the maximum tolerated dose of autologous dendritic cells pulsed with autologous tumor cell lysate in patients with stage III or IV melanoma
Determine the safety and tolerability of this therapy in these patients
Secondary
Determine the immune response in terms of the type and degree of T-cell proliferation and delayed-type hypersensitivity responses in patients treated with this therapy
OUTLINE This is a dose-escalation pilot study
Patients undergo leukapheresis for the collection of peripheral blood mononuclear cells PBMC on days -9 19 and 47 Autologous dendritic cells DC are prepared from autologous PBMC exposed to sargramostim GM-CSF interleukin-4 and tumor necrosis factor alpha and pulsed with autologous tumor cell lysate Patients receive autologous tumor cell lysate-pulsed DC IV over 5-10 minutes on days 0 28 and 56
Cohorts of 3-6 patients receive escalating doses of autologous tumor cell lysate-pulsed DC until the maximum tolerated dose MTD is determined The MTD is defined as the dose at which 33 of all patients experience dose-limiting toxicity
Patients are followed at day 84 and then every 3 months thereafter
PROJECTED ACCRUAL A total of 3-20 patients will be accrued for this study within 3-20 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 |
|---|---|---|---|
| DMS-14862 | None | None | None |
| DMS-9935 | None | None | None |