Ignite Creation Date:
2024-05-05 @ 11:41 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00107159
Status:
COMPLETED
Last Update Posted:
2013-11-06
First Post:
2005-04-05
Brief Title:
Vaccine Therapy in Treating Patients With Unresected Stage III or Stage IV Melanoma
Sponsor:
Jonsson Comprehensive Cancer Center
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Study Of Matured Dendritic Cells Pulsed Ex Vivo With 3 Melanoma Cell Line Lysates IDD-3 in Patients With In-Transit or Metastatic Melanoma
Status:
COMPLETED
Status Verified Date:
2007-04
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 white blood cells and a donors tumor cells may help the body build an effective immune response to kill tumor cells
PURPOSE This phase II trial is studying how well vaccine therapy works in treating patients with unresected stage III or stage IV melanoma
PURPOSE This phase II trial is studying how well vaccine therapy works in treating patients with unresected stage III or stage IV melanoma
Detailed Description:
OBJECTIVES
Primary
Determine the clinical activity of vaccine therapy comprising autologous dendritic cells pulsed with allogeneic melanoma tumor cell lysates IDD-3 as measured by tumor control in patients with unresected stage IIIB or IIIC or stage IV melanoma
Secondary
Determine the immunologic activity of this vaccine as measured by T-cell and antibody responses to lysate or to melanoma antigens or peptides in these patients
Determine the safety of this vaccine as measured by the incidence and severity of adverse events in these patients
OUTLINE This is an open-label multicenter study
Patients undergo apheresis to collect peripheral blood mononuclear cells PBMCs The PBMCs are cultured with sargramostim GM-CSF and interleukin-13 for the production of dendritic cells The dendritic cells are then pulsed with lysates from 3 allogeneic melanoma tumor cell lines IDD-3 to produce the vaccine
Patients receive vaccine therapy comprising IDD-3 administered as 1 subcutaneous and 5 intradermal injections at each of the 2 uninvolved lymph node-bearing regions once in weeks 0 2 4 6 8 10 16 and 22 in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed at 2 10 18 and 26 weeks
PROJECTED ACCRUAL A total of 12-37 patients will be accrued for this study within 4-12 months
Primary
Determine the clinical activity of vaccine therapy comprising autologous dendritic cells pulsed with allogeneic melanoma tumor cell lysates IDD-3 as measured by tumor control in patients with unresected stage IIIB or IIIC or stage IV melanoma
Secondary
Determine the immunologic activity of this vaccine as measured by T-cell and antibody responses to lysate or to melanoma antigens or peptides in these patients
Determine the safety of this vaccine as measured by the incidence and severity of adverse events in these patients
OUTLINE This is an open-label multicenter study
Patients undergo apheresis to collect peripheral blood mononuclear cells PBMCs The PBMCs are cultured with sargramostim GM-CSF and interleukin-13 for the production of dendritic cells The dendritic cells are then pulsed with lysates from 3 allogeneic melanoma tumor cell lines IDD-3 to produce the vaccine
Patients receive vaccine therapy comprising IDD-3 administered as 1 subcutaneous and 5 intradermal injections at each of the 2 uninvolved lymph node-bearing regions once in weeks 0 2 4 6 8 10 16 and 22 in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed at 2 10 18 and 26 weeks
PROJECTED ACCRUAL A total of 12-37 patients will be accrued for this study within 4-12 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 |
|---|---|---|---|
| IDM-DC-MEL-202 | None | None | None |
| UCLA-0408080-01 | None | None | None |