Ignite Creation Date:
2024-05-05 @ 9:36 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002786
Status:
COMPLETED
Last Update Posted:
2010-05-10
First Post:
1999-11-01
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 GENETICALLY MODIFIED AND UNMODIFIED AUTOLOGOUS CD8 TYROSINASE-SPECIFIC T CELLS 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 use different ways to stimulate the immune system and stop cancer cells from growing
PURPOSE Phase III trial to study the effectiveness of biological therapy in treating patients who have metastatic melanoma
PURPOSE Phase III trial to study the effectiveness of biological therapy in treating patients who have metastatic melanoma
Detailed Description:
OBJECTIVES
Assess the safety and toxicity of cellular adoptive immunotherapy using autologous CD8 antigen-specific T-cell clones in patients with metastatic melanoma
Estimate the duration of in vivo persistence of adoptively transferred CD8 antigen-specific cytotoxic T-cell clones in these patients
Evaluate the antitumor effects of CD8 antigen-specific T-cell clones in these patients
OUTLINE Autologous peripheral blood mononuclear cells are harvested and then CD8 cytotoxic T-lymphocyte CTL clones targeting melanosomal antigens are generated ex vivo Patients receive cellular adoptive immunotherapy comprising autologous CD8 CTL clones over 30 minutes on day 1 Patients also receive interleukin-2 subcutaneously every 12 hours on days 1-14 of courses 2-3 Treatment repeats every 3 weeks for 3 courses in the absence of disease progression or unacceptable toxicity
Patients are followed for approximately 1 year after the last infusion
PROJECTED ACCRUAL Approximately 20 patients will be accrued for this study
Assess the safety and toxicity of cellular adoptive immunotherapy using autologous CD8 antigen-specific T-cell clones in patients with metastatic melanoma
Estimate the duration of in vivo persistence of adoptively transferred CD8 antigen-specific cytotoxic T-cell clones in these patients
Evaluate the antitumor effects of CD8 antigen-specific T-cell clones in these patients
OUTLINE Autologous peripheral blood mononuclear cells are harvested and then CD8 cytotoxic T-lymphocyte CTL clones targeting melanosomal antigens are generated ex vivo Patients receive cellular adoptive immunotherapy comprising autologous CD8 CTL clones over 30 minutes on day 1 Patients also receive interleukin-2 subcutaneously every 12 hours on days 1-14 of courses 2-3 Treatment repeats every 3 weeks for 3 courses in the absence of disease progression or unacceptable toxicity
Patients are followed for approximately 1 year after the last infusion
PROJECTED ACCRUAL Approximately 20 patients will be accrued for this study
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 |
|---|---|---|---|
| CDR0000064846 | REGISTRY | PDQ | None |
| FHCRC-101701 | None | None | None |
| NCI-V96-0920 | None | None | None |