NCT00136422

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 or acute myelogenous leukemia.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jan 2000

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2000

Completed
5.7 years until next milestone

First Submitted

Initial submission to the registry

August 25, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 29, 2005

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2006

Completed
Last Updated

March 10, 2011

Status Verified

March 1, 2011

Enrollment Period

6.2 years

First QC Date

August 25, 2005

Last Update Submit

March 9, 2011

Conditions

Acute Myelogenous LeukemiaMyelodysplasia

Keywords

AMLacute myelogenous leukemiaMDSmyelodysplasiavaccine

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • To determine the safety and biologic activity of vaccination with lethally irradiated, autologous myeloblastic leukemia cells engineered by adenoviral mediated gene transfer to secrete GM-CSF in patients with MDS or AML

Interventions

autologous tumor cellsBIOLOGICAL

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Leukemia, Myeloid, AcuteAnemia, Refractory, with Excess of Blasts

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesAnemia, RefractoryAnemiaMyelodysplastic SyndromesBone Marrow Diseases

Study Officials

  • Daniel J. DeAngelo, MD, PhD

    Dana-Farber Cancer Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 25, 2005

First Posted

August 29, 2005

Study Start

January 1, 2000

Primary Completion

March 1, 2006

Study Completion

March 1, 2006

Last Updated

March 10, 2011

Record last verified: 2011-03

Locations

US(1)