Back to resultsStudy of Iressa in Patients With Relapsed or Refractory Acute Myelogenous Leukemia
Primary Purpose
Myelogenous Leukemia, Acute
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
gefitinib
Sponsored by
About this trial
This is an interventional treatment trial for Myelogenous Leukemia, Acute focused on measuring AML, acute myelogenous leukemia, gefitinib, Iressa
Eligibility Criteria
Inclusion Criteria: 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 Criteria: 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
Sites / Locations
- Dana-Farber Cancer Institute
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Gefitinib (Iressa)
Arm Description
All patients will receive Gefitinib (Iressa) at a dose of 750 mg orally (three 250 mg tabs) each day.
Outcomes
Primary Outcome Measures
To determine the response rate of Iressa in patients with acute myelogenous leukemia
Secondary Outcome Measures
To determine the safety of Iressa in patients with acute myelogenous leukemia
to determine the biologic activity of Iressa in patients with acute myelogenous leukemia
Full Information
NCT ID
NCT00130702
First Posted
August 15, 2005
Last Updated
April 29, 2014
Sponsor
Dana-Farber Cancer Institute
Collaborators
Brigham and Women's Hospital, Boston Children's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00130702
Brief Title
Study of Iressa in Patients With Relapsed or Refractory Acute Myelogenous Leukemia
Official Title
A Phase II Study of Iressa (Gefitinib), in Patients With Relapsed or Refractory Acute Myelogenous Leukemia and in Older Patients With Newly Diagnosed Acute Myelogenous Leukemia
Study Type
Interventional
2. Study Status
Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
August 2005 (undefined)
Primary Completion Date
November 2007 (Actual)
Study Completion Date
November 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dana-Farber Cancer Institute
Collaborators
Brigham and Women's Hospital, Boston Children's Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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 8 weeks, a physical exam and complete blood count with differential will be performed.
For the first year, a physical exam, bloodwork will be performed monthly. Bone marrow biopsies will be performed after the first month of therapy and then every 3 months for the first year. After the first year a physical exam, bloodwork will be performed every 3 months and bone marrow biopsies every 6 months.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myelogenous Leukemia, Acute
Keywords
AML, acute myelogenous leukemia, gefitinib, Iressa
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Gefitinib (Iressa)
Arm Type
Experimental
Arm Description
All patients will receive Gefitinib (Iressa) at a dose of 750 mg orally (three 250 mg tabs) each day.
Intervention Type
Drug
Intervention Name(s)
gefitinib
Other Intervention Name(s)
Iressa
Intervention Description
gefitinib (Iressa) at a dose of 750 mg, once per day
Primary Outcome Measure Information:
Title
To determine the response rate of Iressa in patients with acute myelogenous leukemia
Secondary Outcome Measure Information:
Title
To determine the safety of Iressa in patients with acute myelogenous leukemia
Time Frame
2 years
Title
to determine the biologic activity of Iressa in patients with acute myelogenous leukemia
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel J DeAngelo, MD, PhD
Organizational Affiliation
Dana-Farber Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Study of Iressa in Patients With Relapsed or Refractory Acute Myelogenous Leukemia
We'll reach out to this number within 24 hrs