Study of Iressa in Patients With Relapsed or Refractory Acute Myelogenous Leukemia

Myelogenous Leukemia, Acute Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00130702
• Other study ID #: 05-086
• Status: Completed
• Phase: Phase 2
• First received: August 15, 2005
• Last updated: April 29, 2014
• Start date: August 2005
• Est. completion date: November 2007

Study information

• Verified date: April 2014
• Source: Dana-Farber Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine how effective, and to what extent, Iressa is in the treatment of acute myelogenous leukemia.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: November 2007
• Est. primary completion date: November 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute
• Myelogenous Leukemia, Acute

Intervention

Drug:
• gefitinib
gefitinib (Iressa) at a dose of 750 mg, once per day

Locations

Country	Name	City	State
United States	Dana-Farber Cancer Institute	Boston	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
Dana-Farber Cancer Institute	Brigham and Women's Hospital, Children's Hospital Boston

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine the response rate of Iressa in patients with acute myelogenous leukemia		TBD	No
Secondary	To determine the safety of Iressa in patients with acute myelogenous leukemia		2 years	Yes
Secondary	to determine the biologic activity of Iressa in patients with acute myelogenous leukemia		2 years	No