Ignite Creation Date:
2024-05-05 @ 4:47 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00317759
Status:
COMPLETED
Last Update Posted:
2015-10-01
First Post:
2006-04-24
Brief Title:
Fludarabine Followed By Adoptive Immunotherapy in Treating Patients With Stage IV Melanoma
Sponsor:
Fred Hutchinson Cancer Center
Organization:
Fred Hutchinson Cancer Center
Study Overview
Official Title:
Phase I Study to Evaluate the Safety of Cellular Adoptive Immunotherapy Using Autologous CD8 Antigen-Specific T Cell Clones Following Fludarabine Lymphodepletion for Patients With Metastatic Melanoma
Status:
COMPLETED
Status Verified Date:
2010-05
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 Biological therapies such as cellular adoptive immunotherapy use different ways to stimulate the immune system and stop cancer cells from growing Fludarabine may help the immune system kill more cancer cells
PURPOSE Phase I trial to study the effectiveness of fludarabine followed by cellular adoptive immunotherapy in treating patients who have metastatic melanoma
PURPOSE Phase I trial to study the effectiveness of fludarabine followed by cellular adoptive immunotherapy in treating patients who have metastatic melanoma
Detailed Description:
OBJECTIVES
Primary
Determine the safety and toxicity of adoptive immunotherapy comprising autologous CD8 antigen-specific cytotoxic T-lymphocyte CTL clones after fludarabine in patients with stage IV melanoma
Determine the duration of in vivo persistence of these CTL clones in these patients
Secondary
Determine the antitumor effect of this regimen in these patients
OUTLINE This is an open-label nonrandomized study
Patients undergo leukapheresis or weekly phlebotomy for the collection of peripheral blood mononuclear cells from which autologous antigen-specific CD8 cytotoxic T-lymphocyte CTL clones are generated Patients receive autologous antigen-specific CD8 CTL clones IV over 30-60 minutes on days 0 and 21 in the absence of rapid disease progression or unacceptable toxicity Patients also receive fludarabine IV once daily on days 14-18
Patients are followed for up to 1 year
PROJECTED ACCRUAL A total of 12 patients will be accrued for this study within 3 years
Primary
Determine the safety and toxicity of adoptive immunotherapy comprising autologous CD8 antigen-specific cytotoxic T-lymphocyte CTL clones after fludarabine in patients with stage IV melanoma
Determine the duration of in vivo persistence of these CTL clones in these patients
Secondary
Determine the antitumor effect of this regimen in these patients
OUTLINE This is an open-label nonrandomized study
Patients undergo leukapheresis or weekly phlebotomy for the collection of peripheral blood mononuclear cells from which autologous antigen-specific CD8 cytotoxic T-lymphocyte CTL clones are generated Patients receive autologous antigen-specific CD8 CTL clones IV over 30-60 minutes on days 0 and 21 in the absence of rapid disease progression or unacceptable toxicity Patients also receive fludarabine IV once daily on days 14-18
Patients are followed for up to 1 year
PROJECTED ACCRUAL A total of 12 patients will be accrued for this study within 3 years
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 |
|---|---|---|---|
| CDR0000327817 | REGISTRY | PDQ | None |
| FHCRC-179600 | None | None | None |