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A Phase I Study of Vaccination With Lethally Irradiated, Autologous Acute Myeloblastic Leukemia Cells Engineered by Adenoviral Mediated Gene Transfer to Secrete Human Granulocyte-Macrophage Colony Stimulating Factor in Patients With Advanced Myelodysplasia or Acute Myelogenous Leukemia


Phase 1
18 Years
N/A
Not Enrolling
Both
Acute Myelogenous Leukemia, Myelodysplasia

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Trial Information

A Phase I Study of Vaccination With Lethally Irradiated, Autologous Acute Myeloblastic Leukemia Cells Engineered by Adenoviral Mediated Gene Transfer to Secrete Human Granulocyte-Macrophage Colony Stimulating Factor in Patients With Advanced Myelodysplasia or Acute Myelogenous Leukemia


This study will make use of leukemic myeloblasts harvested by bone marrow aspirate in
patients with myelodysplasia and acute myelogenous leukemia. These harvested tumor cells
will be modified by adenoviral mediated gene transfer to secrete granulocyte-macrophage
colony stimulating factor (GM-CSF).

Patients will be administered vaccines at one of three dose levels (as determined by total
cell yield). Vaccinations will be given weekly for three weeks, followed by every other
week until the vaccine supply is exhausted or when patients are removed from the study.

The patient will receive a minimum of six vaccinations, but more will be administered if the
vaccine is available.

During the course of the study, patients will be tested to see how their immune system is
reacting to the vaccinations. Testing will include bloodwork evaluating the immune cells in
the body at monthly intervals. Skin biopsies may also be performed to see if an immune
reaction is occuring at the injection site.

During the first course of treatment, a bone marrow biopsy and aspirate may be performed
monthly.

The length of time on this study depends upon the number of vaccines available and whether
or not unacceptable side effects occur.


Inclusion Criteria:



- Patients must have pathologically documented myelodysplasia or acute myelogenous
leukemia.

- The patients with myelodysplasia must also have: French-American-British (FAB)
subtype refractory anemia with excess blasts (RAEB) or refractory anemia with excess
blasts in transformation (RAEB-T), or normal or hypercellular bone marrow.

- The patients with acute myelogenous leukemia must also: not be candidates for
myelosuppressive chemotherapy due to age or comorbid disease, or have relapsed acute
myelogenous leukemia or be refractory to standard therapy and not likely to require
cytoreductive therapy within 60 days

- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.

- Estimated life expectancy of 6 months or greater.

- Age at least 18 years.

- Greater than 4 weeks from any chemotherapy, radiotherapy, immunotherapy, or systemic
glucocorticoid therapy (non-glucocorticoid hormonal therapy allowed).

- Greater than 2 months following bone marrow or peripheral blood stem cell
transplantation or treatment with donor lymphocyte infusion (DLI).

Exclusion Criteria:

- Uncontrolled active infection.

- Pregnancy or nursing mothers.

- Previous participation in an adenovirus based trial.

- The patients with myelodysplasia who have either: FAB subtype refractory anemia (RA),
refractory anemia with ringed sideroblasts (RARS), chronic myelomonocytic leukemia
(CMML), or the presence of hypocellular bone marrow.

- Chemotherapy, radiotherapy, immunotherapy, or systemic steroid therapy within the
last 4 weeks.

- Active central nervous system (CNS) disease.

- Evidence of infection with the human immunodeficiency virus.

- Active psychiatric or mental illness making informed consent or careful clinical
follow-up unlikely.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

To determine the feasibility of preparing lethally irradiated autologous myeloblastic leukemia cells engineered by adenoviral mediated gene transfer to secrete GM-CSF in patients with myelodysplastic syndromes (MDS) or AML

Principal Investigator

Daniel J. DeAngelo, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dana-Farber Cancer Institute

Authority:

United States: Institutional Review Board

Study ID:

99-249

NCT ID:

NCT00136422

Start Date:

January 2000

Completion Date:

March 2006

Related Keywords:

  • Acute Myelogenous Leukemia
  • Myelodysplasia
  • AML
  • acute myelogenous leukemia
  • MDS
  • myelodysplasia
  • vaccine
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid
  • Myelodysplastic Syndromes
  • Preleukemia

Name

Location

Dana-Farber Cancer InstituteBoston, Massachusetts  02115