NCT00100971

Brief Summary

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.

Trial Health

57
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Trial Health Score

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

Enrollment
9

participants targeted

Target at below P25 for phase_1 leukemia

Timeline
Completed

Started Apr 2004

Geographic Reach
1 country

1 active site

Status
terminated

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2004

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

January 7, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 10, 2005

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2007

Completed
Last Updated

January 4, 2013

Status Verified

January 1, 2013

Enrollment Period

2.9 years

First QC Date

January 7, 2005

Last Update Submit

January 3, 2013

Conditions

Leukemia

Keywords

adult acute myeloid leukemia with 11q23 (MLL) abnormalitiesadult 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

Interventions

autologous tumor cell vaccineDRUG
therapeutic autologous dendritic cellsDRUG
tumor cell-derivative vaccine therapyPROCEDURE

Eligibility Criteria

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Cancer Research Center at Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

MeSH Terms

Conditions

LeukemiaCongenital Abnormalities

Interventions

FANG vaccine

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Adam Lerner, MD

    Boston Medical Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 7, 2005

First Posted

January 10, 2005

Study Start

April 1, 2004

Primary Completion

March 1, 2007

Study Completion

March 1, 2007

Last Updated

January 4, 2013

Record last verified: 2013-01

Locations

US(1)