Status:
COMPLETED
Study of Iressa in Patients With Relapsed or Refractory Acute Myelogenous Leukemia
Lead Sponsor:
Dana-Farber Cancer Institute
Collaborating Sponsors:
Brigham and Women's Hospital
Boston Children's Hospital
Conditions:
Myelogenous Leukemia, Acute
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to determine how effective, and to what extent, Iressa is in the treatment of acute myelogenous leukemia.
Detailed Description
Patients will receive Iressa daily until either disease progression or intolerable toxicity develops. On Day 1 of treatment, a physical exam and bloodwork will be performed. Once weekly for the first ...
Eligibility Criteria
Inclusion
- Patients must have pathologically documented acute myelogenous leukemia and either not be a candidate 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 30 days.
- ECOG performance status 0, 1 or 2
- Age \> 18 years
- Adequate kidney and hepatic function
- Greater than 4 weeks from any chemotherapy, radiotherapy, immunotherapy, or systemic steroid therapy with the exception of hydroxyurea.
- Greater than 2 months following bone marrow or peripheral blood stem cell transplantation or donor lymphocyte infusion.
Exclusion
- Uncontrolled active infection
- Urgent need for cytoreductive chemotherapy, surgery, or radiotherapy
- Current chemotherapy or chemotherapy within the last 4 weeks.
- Pregnancy or nursing mothers
- Infection with HIV
Key Trial Info
Start Date :
August 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2007
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT00130702
Start Date
August 1 2005
End Date
November 1 2007
Last Update
May 1 2014
Active Locations (1)
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1
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115