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

Dana-Farber Cancer Institute18 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Myelogenous Leukemia, Acute

Interventions

gefitinibDRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Outcomes

Primary Outcomes

To determine the response rate of Iressa in patients with acute myelogenous leukemia

Secondary Outcomes

To determine the safety of Iressa in patients with acute myelogenous leukemia

Time frame: 2 years

to determine the biologic activity of Iressa in patients with acute myelogenous leukemia

Time frame: 2 years

Data from ClinicalTrials.gov

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