Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00020670
Status:
TERMINATED
Last Update Posted:
2017-06-20
First Post:
2001-07-11
Brief Title:
Vaccine Therapy in Treating Patients With Acute Lymphoblastic Leukemia
Sponsor:
Dana-Farber Cancer Institute
Organization:
Dana-Farber Cancer Institute
Study Overview
Official Title:
A Phase I Study of Vaccination With Autologous CD40-Activated Acute Lymphoblastic Leukemia Cells
Status:
TERMINATED
Status Verified Date:
2017-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Slow accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The prognosis for children and adults with acute lymphoblastic leukemia ALL has improved significantly over the years Nevertheless patients who experience disease relapse or induction failure along with patients having unfavorable genetics t411 or t922 have dismal prognosis For these patients novel therapeutic approaches such as immunotherapy are needed In this clinical trial investigators evaluate whether it is feasible to make a vaccine from leukemia cells and whether this vaccine enables direct immunity against cancer cells in patients
Detailed Description:
OBJECTIVES Primary
To determine feasibility of generating a cellular vaccine composed of CD40-activated autologous ALL cells
To determine feasibility of vaccine administration according to the proposed schedule
To determine toxicity of vaccination with CD40-activated autologous ALL cells
Secondary
To assess ALL-specific immunity following vaccination
To assess the generation of immunity to control antigens
To develop preliminary information on effect vaccination on tumor response
To determine feasibility of generating a cellular vaccine composed of CD40-activated autologous ALL cells
To determine feasibility of vaccine administration according to the proposed schedule
To determine toxicity of vaccination with CD40-activated autologous ALL cells
Secondary
To assess ALL-specific immunity following vaccination
To assess the generation of immunity to control antigens
To develop preliminary information on effect vaccination on tumor response
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 |
|---|---|---|---|
| NCI-H01-0074 | US NIH GrantContract | None | httpsreporternihgovquickSearchP30CA006516 |
| P01CA068484 | NIH | None | None |
| P30CA006516 | NIH | None | None |
| DFCI-00053 | None | None | None |