Ignite Creation Date:
2024-05-05 @ 11:41 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00100971
Status:
TERMINATED
Last Update Posted:
2013-01-04
First Post:
2005-01-07
Brief Title:
Vaccine Therapy in Treating Patients With Acute Myeloid Leukemia
Sponsor:
Boston Medical Center
Organization:
Boston Medical Center
Study Overview
Official Title:
DendriticLeukemic Fusion Cell Vaccine Therapy For AML Patients In First Remission A Phase I Clinical Trial
Status:
TERMINATED
Status Verified Date:
2013-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Protocol is withdrawn due to inadequate accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Vaccines made from a persons white blood cells and cancer cells may make the body build an effective immune response to kill cancer cells
PURPOSE This phase I trial is studying the side effects and best dose of vaccine therapy in treating patients with acute myeloid leukemia
PURPOSE This phase I trial is studying the side effects and best dose of vaccine therapy in treating patients with acute myeloid leukemia
Detailed Description:
OBJECTIVES
Primary
Determine the maximum tolerated dose of autologous dendritic and leukemic fusion cell vaccine in patients with acute myeloid leukemia
Determine the toxicity of this vaccine in these patients
Secondary
Determine whether cellular immunity can be induced by this vaccine in these patients
OUTLINE This is a dose-escalation study
At the time of diagnosis patients undergo tumor cell harvest Patients also undergo bone marrow aspiration to collect mononuclear cells to obtain dendritic cells DC If insufficient DCs are obtained patients undergo leukapheresis to obtain a sufficient number of peripheral blood mononuclear cells PBMC The PBMC are treated in the laboratory with sargramostim GM-CSF and interleukin-4 for 5-7 days to produce DC Leukemic blasts are fused to DC to generate the dendriticleukemic fusion cell vaccine
Patients then undergo standard induction chemotherapy to obtain a remission followed by standard consolidation chemotherapy
After completing consolidation chemotherapy patients receive autologous dendritic and leukemic fusion cell vaccine subcutaneously every 2 weeks for a total of 4 doses in the absence of disease progression or unacceptable toxicity
Cohorts of 3 patients receive escalating doses of autologous dendritic and leukemic fusion cell vaccine until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 patients experience dose-limiting toxicity
Patients are followed every 3 months for 5 years
PROJECTED ACCRUAL A total of 3-9 patients will be accrued for this study
Primary
Determine the maximum tolerated dose of autologous dendritic and leukemic fusion cell vaccine in patients with acute myeloid leukemia
Determine the toxicity of this vaccine in these patients
Secondary
Determine whether cellular immunity can be induced by this vaccine in these patients
OUTLINE This is a dose-escalation study
At the time of diagnosis patients undergo tumor cell harvest Patients also undergo bone marrow aspiration to collect mononuclear cells to obtain dendritic cells DC If insufficient DCs are obtained patients undergo leukapheresis to obtain a sufficient number of peripheral blood mononuclear cells PBMC The PBMC are treated in the laboratory with sargramostim GM-CSF and interleukin-4 for 5-7 days to produce DC Leukemic blasts are fused to DC to generate the dendriticleukemic fusion cell vaccine
Patients then undergo standard induction chemotherapy to obtain a remission followed by standard consolidation chemotherapy
After completing consolidation chemotherapy patients receive autologous dendritic and leukemic fusion cell vaccine subcutaneously every 2 weeks for a total of 4 doses in the absence of disease progression or unacceptable toxicity
Cohorts of 3 patients receive escalating doses of autologous dendritic and leukemic fusion cell vaccine until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 patients experience dose-limiting toxicity
Patients are followed every 3 months for 5 years
PROJECTED ACCRUAL A total of 3-9 patients will be accrued for this study
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| BUMC-2003-099 | None | None | None |