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(Protocol is withdrawn due to inadequate accrual)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
  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.


Condition Intervention Phase
Leukemia
Drug: autologous tumor cell vaccine
Drug: therapeutic autologous dendritic cells
Procedure: tumor cell-derivative vaccine therapy
Phase 1

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Dendritic/Leukemic Fusion Cell Vaccine Therapy For AML Patients In First Remission; A Phase I Clinical Trial

Resource links provided by NLM:


Further study details as provided by Boston Medical Center:

Estimated Enrollment: 9
Study Start Date: April 2004
Study Completion Date: March 2007
Primary Completion Date: March 2007 (Final data collection date for primary outcome measure)
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 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00100971

Locations
United States, Massachusetts
Cancer Research Center at Boston Medical Center
Boston, Massachusetts, United States, 02118
Sponsors and Collaborators
Boston Medical Center
Investigators
Study Chair: Adam Lerner, MD Boston Medical Center
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00100971     History of Changes
Other Study ID Numbers: CDR0000404382, BUMC-2003-099
Study First Received: January 7, 2005
Last Updated: January 3, 2013
Health Authority: United States: Federal Government

Keywords provided by Boston Medical Center:
adult acute myeloid leukemia with 11q23 (MLL) abnormalities
adult acute myeloid leukemia with inv(16)(p13;q22)
adult acute myeloid leukemia with t(15;17)(q22;q12)
adult acute myeloid leukemia with t(16;16)(p13;q22)
adult acute myeloid leukemia with t(8;21)(q22;q22)
secondary acute myeloid leukemia

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid, Acute
Leukemia, Myeloid
Neoplasms by Histologic Type
Neoplasms

ClinicalTrials.gov processed this record on July 28, 2014