Vaccine Therapy in Treating Patients With Acute Myeloid Leukemia

This study has been terminated.
(Protocol is withdrawn due to inadequate accrual)
Sponsor:
Information provided by:
Boston Medical Center
ClinicalTrials.gov Identifier:
NCT00100971
First received: January 7, 2005
Last updated: January 3, 2013
Last verified: January 2013

January 7, 2005
January 3, 2013
April 2004
March 2007   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00100971 on ClinicalTrials.gov Archive Site
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Vaccine Therapy in Treating Patients With Acute Myeloid Leukemia
Dendritic/Leukemic Fusion Cell Vaccine Therapy For AML Patients In First Remission; A Phase I Clinical Trial

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.

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.

Interventional
Phase 1
Primary Purpose: Treatment
Leukemia
  • Drug: autologous tumor cell vaccine
  • Drug: therapeutic autologous dendritic cells
  • Procedure: tumor cell-derivative vaccine therapy
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
9
March 2007
March 2007   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00100971
CDR0000404382, BUMC-2003-099
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Boston Medical Center
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Study Chair: Adam Lerner, MD Boston Medical Center
Boston Medical Center
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP