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

• Status: Completed
• Trial end date: 2007-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dana-Farber Cancer Institute
• Collaborators: Boston Children's Hospital; Boston Children’s Hospital; Brigham and Women's Hospital
• Treatments: Gefitinib

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