Acute myelogenous leukemia is an aggressive disease that is generally treated with very strong medicines called chemotherapy. These medicines can kill leukemia cells but also kill many other cells and patients often get a lot of side effects. Despite this aggressive therapy only a subset of patients will benefit from the treatment. Recently, laboratory studies have identified specific abnormalities in leukemia cells that might be reversed by standard medications frequently used to treat patients with other diseases. In this study, these medications will be added to the standard chemotherapy treatment given to patients with acute leukemia. The objective of the study is to determine if adding these standard medications to standard chemotherapy results in reversal of some of the abnormalities found in leukemia cells. If so, we will design another study that tests whether adding these medicines to standard chemotherapy improves the results of treatment.

Condition	Intervention
Acute Non-lymphocytic Leukemia	Drug: Nuclear Factor-kappa

Further Study Details: 

Primary Outcomes: To determine various effects of NFkB inhibitors
Expected Total Enrollment:  24

Acute myelogenous leukemia is an aggressive disease that is generally treated with very strong medicines called chemotherapy. These medicines can kill leukemia cells but also kill many other cells and patients often get a lot of side effects. Despite this aggressive therapy only a subset of patients will benefit from the treatment. Recently, laboratory studies have identified specific abnormalities in leukemia cells that might be reversed by standard medications frequently used to treat patients with other diseases. In this study, these medications will be added to the standard chemotherapy treatment given to patients with acute leukemia. The objective of the study is to determine if adding these standard medications to standard chemotherapy results in reversal of some of the abnormalities found in leukemia cells. If so, we will design another study that tests whether adding these medicines to standard chemotherapy improves the results of treatment.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Accepts Healthy Volunteers

Criteria

inclusion:

a) Patients must have a new diagnosis of ANLL (with exception of patients with M3 subtype) and no prior induction chemotherapy d) Women of childbearing potential must have a negative pregnancy test.

Exclusion:

Any coexisting medical condition or medications precluding full compliance with any of the arms of the study.

Prior chemotherapy for acute leukemia.. c) Allergies to any investigational drugs and/or to the chemotherapeutic agents.

d) Endoscopically documented upper or lower GI related hemorrhage within last 6 months. Also, patients with a clinical diagnosis of GI bleeding requiring blood transfusions will be excluded.

Please refer to this study by ClinicalTrials.gov identifier  NCT00156299

Roger Strair, MD      732-235-7298    strairrk@umdnj.edu

New Jersey
      Cancer Institute of New Jersey, New Brunswick,  New Jersey,  08901,  United States; Recruiting

Study chairs or principal investigators

Roger Strair, MD,  Principal Investigator,  University of Medicine and Dentistry New Jersey   

Study ID Numbers:  4158; CINJ#020201
Last Updated:  September 9, 2005
Record first received:  September 8, 2005
ClinicalTrials.gov Identifier:  NCT00156299
Health Authority: United States: Institutional Review Board
ClinicalTrials.gov processed this record on 2005-09-13