Expired Study
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Boston, Massachusetts 02118


Purpose:

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.


Study summary:

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 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.


Criteria:

DISEASE CHARACTERISTICS: - Diagnosis of acute myeloid leukemia (AML) by bone marrow biopsy - Newly diagnosed - Must have adequate dendritic cells and AML blasts isolated from bone marrow and/or peripheral blood - No clinical evidence of CNS leukemia PATIENT CHARACTERISTICS: Age - 18 and over Performance status - Not specified Life expectancy - Not specified Hematopoietic - Not specified Hepatic - Not specified Renal - Not specified Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - HIV negative - No clinically significant autoimmune disease - No other active malignancy except nonmelanoma skin cancer PRIOR CONCURRENT THERAPY: Biologic therapy - More than 3 months since prior immunotherapy Chemotherapy - Not specified Endocrine therapy - Not specified Radiotherapy - Not specified Surgery - Not specified


NCT ID:

NCT00100971


Primary Contact:

Study Chair
Adam Lerner, MD
Boston Medical Center


Backup Contact:

N/A


Location Contact:

Boston, Massachusetts 02118
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: December 16, 2017

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