Study of Iressa in Patients With Relapsed or Refractory 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.

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