Vaccine Therapy in Treating Patients With Acute Myeloid Leukemia
|ClinicalTrials.gov Identifier: NCT00100971|
Recruitment Status : Terminated (Protocol is withdrawn due to inadequate accrual)
First Posted : January 10, 2005
Last Update Posted : January 4, 2013
RATIONALE: Vaccines made from a person's 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.
|Condition or disease||Intervention/treatment||Phase|
|Leukemia||Drug: autologous tumor cell vaccine Drug: therapeutic autologous dendritic cells Procedure: tumor cell-derivative vaccine therapy||Phase 1|
- 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.
- 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 dendritic/leukemic 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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||9 participants|
|Official Title:||Dendritic/Leukemic Fusion Cell Vaccine Therapy For AML Patients In First Remission; A Phase I Clinical Trial|
|Study Start Date :||April 2004|
|Primary Completion Date :||March 2007|
|Study Completion Date :||March 2007|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00100971
|United States, Massachusetts|
|Cancer Research Center at Boston Medical Center|
|Boston, Massachusetts, United States, 02118|
|Study Chair:||Adam Lerner, MD||Boston Medical Center|