Ignite Creation Date:
2024-05-05 @ 11:26 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00045149
Status:
COMPLETED
Last Update Posted:
2010-05-07
First Post:
2002-09-06
Brief Title:
Biological Therapy in Treating Patients With Metastatic 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 Targeting Cancer Testis Antigens 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 Treating a persons white blood cells in the laboratory and then reinfusing them may cause a stronger immune response and kill more tumor cells
PURPOSE Phase I trial to study the effectiveness of biological therapy in treating patients who have metastatic melanoma
PURPOSE Phase I trial to study the effectiveness of biological therapy in treating patients who have metastatic melanoma
Detailed Description:
OBJECTIVES
Primary
Determine the safety and toxicity of cellular adoptive immunotherapy comprising autologous CD8 cytotoxic T-lymphocyte clones targeting cancer-testis antigens in patients with metastatic melanoma
Determine the duration of in vivo persistence of this therapy in these patients
Secondary
Evaluate the antitumor effects of this therapy in these patients
OUTLINE Patients undergo leukapheresis to obtain peripheral blood mononuclear cells and then CD8 cytotoxic T-lymphocyte CTL clones are generated ex vivo Patients receive cellular adoptive immunotherapy comprising autologous CD8 CTL clones targeting cancer testis antigens IV over 30 minutes on day 1 Patients also receive interleukin-2 subcutaneously every 12 hours on days 1-14 of courses 2-4 Treatment repeats every 3 weeks for 4 courses in the absence of disease progression or unacceptable toxicity Patients who demonstrate a clinical response after completion of the fourth course are eligible to receive additional T-cell infusions
Patients are followed for 9 months
PROJECTED ACCRUAL A total of 20 patients will be accrued for this study within 3 years
Primary
Determine the safety and toxicity of cellular adoptive immunotherapy comprising autologous CD8 cytotoxic T-lymphocyte clones targeting cancer-testis antigens in patients with metastatic melanoma
Determine the duration of in vivo persistence of this therapy in these patients
Secondary
Evaluate the antitumor effects of this therapy in these patients
OUTLINE Patients undergo leukapheresis to obtain peripheral blood mononuclear cells and then CD8 cytotoxic T-lymphocyte CTL clones are generated ex vivo Patients receive cellular adoptive immunotherapy comprising autologous CD8 CTL clones targeting cancer testis antigens IV over 30 minutes on day 1 Patients also receive interleukin-2 subcutaneously every 12 hours on days 1-14 of courses 2-4 Treatment repeats every 3 weeks for 4 courses in the absence of disease progression or unacceptable toxicity Patients who demonstrate a clinical response after completion of the fourth course are eligible to receive additional T-cell infusions
Patients are followed for 9 months
PROJECTED ACCRUAL A total of 20 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 |
|---|---|---|---|
| FHCRC-158800 | None | None | None |
| NCI-H02-0091 | None | None | None |
| CDR0000256451 | REGISTRY | PDQ | None |