Ignite Creation Date:
2024-05-05 @ 11:27 PM
Last Modification Date:
2024-10-26 @ 10:34 AM
Study NCT ID:
NCT01339663
Status:
COMPLETED
Last Update Posted:
2014-04-21
First Post:
2011-04-18
Brief Title:
Vaccine Therapy Following Therapeutic Autologous Lymphocytes and Cyclophosphamide 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 Use Of Autologous T- Antigen-Presenting Cells T-APC To Enhance The Persistence Of Adoptively Transferred CD8 Antigen-Specific T Cells CTL Following Cyclophosphamide Conditioning For Patients With Metastatic Melanoma
Status:
COMPLETED
Status Verified Date:
2014-04
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:
This phase I trial studies the side effects and best dose of autologous T-antigen-presenting cells T-APC vaccine following therapeutic autologous lymphocytes CTL and cyclophosphamide in treating patients with metastatic melanoma Aldesleukin may stimulate lymphocytes such as CTL to kill melanoma cells Treating lymphocytes with aldesleukin in the laboratory may help the lymphocytes kill more tumor cells when they are put back in the body Vaccines made from melanoma antigen may help the body build an effective immune response to kill tumor cells and may boost the effect of the CTL Drugs used in chemotherapy such as cyclophosphamide work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing Giving T-APC vaccine after CTL and cyclophosphamide may be an effective treatment for melanoma
Detailed Description:
PRIMARY OBJECTIVES
I Assess the safety and toxicity of T-APC vaccination following adoptive T cell therapy
II Evaluate the functional and numeric in vivo persistence of adoptively transferred cytotoxic t lymphocytes CTL followed by T-APC vaccination
SECONDARY OBJECTIVES
I Evaluate the antitumor effect of adoptive T cell therapy followed by T-APC vaccination
OUTLINE This is a dose-escalation study of T-APC vaccine
INFUSION I Patients receive high-dose cyclophosphamide intravenously IV on days -4 and -3 and low-dose aldesleukin IL-2 subcutaneously SC twice daily BID on days 0-14 Patients also receive CTL IV on day 0
INFUSION II Beginning 6-48 hours later patients receive high-dose cyclophosphamide low-dose IL-2 and CTL as in Infusion I Patients also receive T-APC vaccine IV within 18-36 hours following CTL infusion and in week 4 and IL-2 SC BID on days 0-14 following second T-APC vaccination
After completion of study treatment patients are followed up for 8 weeks
I Assess the safety and toxicity of T-APC vaccination following adoptive T cell therapy
II Evaluate the functional and numeric in vivo persistence of adoptively transferred cytotoxic t lymphocytes CTL followed by T-APC vaccination
SECONDARY OBJECTIVES
I Evaluate the antitumor effect of adoptive T cell therapy followed by T-APC vaccination
OUTLINE This is a dose-escalation study of T-APC vaccine
INFUSION I Patients receive high-dose cyclophosphamide intravenously IV on days -4 and -3 and low-dose aldesleukin IL-2 subcutaneously SC twice daily BID on days 0-14 Patients also receive CTL IV on day 0
INFUSION II Beginning 6-48 hours later patients receive high-dose cyclophosphamide low-dose IL-2 and CTL as in Infusion I Patients also receive T-APC vaccine IV within 18-36 hours following CTL infusion and in week 4 and IL-2 SC BID on days 0-14 following second T-APC vaccination
After completion of study treatment patients are followed up for 8 weeks
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 |
|---|---|---|---|
| K12CA076930 | NIH | CTRP Clinical Trial Reporting Program | httpsreporternihgovquickSearchK12CA076930 |
| NCI-2011-00383 | REGISTRY | None | None |