Status:
COMPLETED
Study of Vaccination With Autologous Acute Myeloblastic Leukemia Cells in Patients With Advanced Myelodysplasia or Acute Myelogenous Leukemia
Lead Sponsor:
Dana-Farber Cancer Institute
Collaborating Sponsors:
Brigham and Women's Hospital
Conditions:
Acute Myelogenous Leukemia
Myelodysplasia
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The purpose of this study is to test the safety of a new investigational acute myeloblastic leukemia (AML) vaccine and see what effects (good and bad) it has on patients with advanced myelodysplasia o...
Detailed Description
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 adeno...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2000
Trial Type :
INTERVENTIONAL
End Date :
March 1 2006
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00136422
Start Date
January 1 2000
End Date
March 1 2006
Last Update
March 10 2011
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115