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

This study has been completed.
Sponsor:
Collaborators:
Brigham and Women's Hospital
Children's Hospital Boston
Information provided by (Responsible Party):
Daniel J. DeAngelo, MD, PhD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT00130702
First received: August 15, 2005
Last updated: April 29, 2014
Last verified: April 2014
  Purpose

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


Condition Intervention Phase
Myelogenous Leukemia, Acute
Drug: gefitinib
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Dana-Farber Cancer Institute:

Primary Outcome Measures:
  • To determine the response rate of Iressa in patients with acute myelogenous leukemia [ Time Frame: TBD ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To determine the safety of Iressa in patients with acute myelogenous leukemia [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • to determine the biologic activity of Iressa in patients with acute myelogenous leukemia [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Enrollment: 18
Study Start Date: August 2005
Study Completion Date: November 2007
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Gefitinib (Iressa)
All patients will receive Gefitinib (Iressa) at a dose of 750 mg orally (three 250 mg tabs) each day.
Drug: gefitinib
gefitinib (Iressa) at a dose of 750 mg, once per day
Other Name: Iressa

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00130702

Locations
United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Dana-Farber Cancer Institute
Brigham and Women's Hospital
Children's Hospital Boston
Investigators
Principal Investigator: Daniel J DeAngelo, MD, PhD Dana-Farber Cancer Institute
  More Information

No publications provided

Responsible Party: Daniel J. DeAngelo, MD, PhD, Principal Investigator, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT00130702     History of Changes
Other Study ID Numbers: 05-086
Study First Received: August 15, 2005
Last Updated: April 29, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Dana-Farber Cancer Institute:
AML
acute myelogenous leukemia
gefitinib
Iressa

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms
Neoplasms by Histologic Type
Gefitinib
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protein Kinase Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on October 21, 2014