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Dendritic/Leukemic Fusion Cell Vaccine Therapy For AML Patients In First Remission; A Phase I Clinical Trial


Phase 1
18 Years
N/A
Not Enrolling
Both
Leukemia

Thank you

Trial Information

Dendritic/Leukemic Fusion Cell Vaccine Therapy For AML Patients In First Remission; A Phase I Clinical Trial


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Adam Lerner, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Boston Medical Center

Authority:

United States: Federal Government

Study ID:

CDR0000404382

NCT ID:

NCT00100971

Start Date:

April 2004

Completion Date:

March 2007

Related Keywords:

  • Leukemia
  • 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
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid

Name

Location

Cancer Research Center at Boston Medical CenterBoston, Massachusetts  02118