Ignite Creation Date:
2025-12-24 @ 3:52 PM
Ignite Modification Date:
2026-01-24 @ 5:02 PM
Study NCT ID:
NCT00658892
Status:
COMPLETED
Last Update Posted:
2017-05-25
First Post:
2008-04-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Monoclonal Antibody Therapy in Treating Patients With Stage IV Melanoma
Sponsor:
Mayo Clinic
Organization:
Study Overview
Official Title:
B7-DC Xab Plasma Therapy for the Treatment of Metastatic Melanoma. A Feasibility/Pilot Study
Status:
COMPLETED
Status Verified Date:
2017-05
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: Monoclonal antibodies can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them.
PURPOSE: This clinical trial is studying the side effects and best dose of a monoclonal antibody in treating patients with stage IV melanoma.
PURPOSE: This clinical trial is studying the side effects and best dose of a monoclonal antibody in treating patients with stage IV melanoma.
Detailed Description:
OBJECTIVES:
Primary
* Determine the safety/toxicity of a single dose of B7-dendritic cell cross-linking antibody containing plasma in treating patients with stage IV melanoma.
Secondary
* Describe the immunological changes (Th1/Th2 balance, frequency of tumor specific cytotoxic T lymphocytes, and plasma cytokine profiles) in the treated patients.
* Determine the treatment impact on tumor growth (e.g., objective response, time to progression).
OUTLINE: Patients receive B7-dendritic cell cross-linking antibody IV once on day 1.
Patients undergo peripheral blood collection at baseline and periodically after infusion for analysis of dendritic cell activation, cytotoxic T-lymphocyte activity, immune cell impact, and serum cytokine changes using immunophenotyping and flow cytometry.
After completion of study treatment patients are followed every 2 months for 5 years.
Primary
* Determine the safety/toxicity of a single dose of B7-dendritic cell cross-linking antibody containing plasma in treating patients with stage IV melanoma.
Secondary
* Describe the immunological changes (Th1/Th2 balance, frequency of tumor specific cytotoxic T lymphocytes, and plasma cytokine profiles) in the treated patients.
* Determine the treatment impact on tumor growth (e.g., objective response, time to progression).
OUTLINE: Patients receive B7-dendritic cell cross-linking antibody IV once on day 1.
Patients undergo peripheral blood collection at baseline and periodically after infusion for analysis of dendritic cell activation, cytotoxic T-lymphocyte activity, immune cell impact, and serum cytokine changes using immunophenotyping and flow cytometry.
After completion of study treatment patients are followed every 2 months for 5 years.
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 ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| P30CA015083 | NIH | None | https://reporter.nih.gov/quic… | View |
| MC0677 | OTHER | Mayo Clinic Cancer Center | View | |
| 06-006992 | OTHER | Mayo Clinic IRB | View | |
| NCI-2009-01343 | REGISTRY | NCI-CTRP | View |