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| Name | Class |
|---|---|
| Brigham and Women's Hospital | OTHER |
| Boston Children's Hospital | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gefitinib (Iressa) | Experimental | All patients will receive Gefitinib (Iressa) at a dose of 750 mg orally (three 250 mg tabs) each day. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| gefitinib | Drug | gefitinib (Iressa) at a dose of 750 mg, once per day |
|
| Measure | Description | Time Frame |
|---|---|---|
| To determine the response rate of Iressa in patients with acute myelogenous leukemia |
| Measure | Description | Time Frame |
|---|---|---|
| To determine the safety of Iressa in patients with acute myelogenous leukemia | 2 years | |
| to determine the biologic activity of Iressa in patients with acute myelogenous leukemia | 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daniel J DeAngelo, MD, PhD | Dana-Farber Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dana-Farber Cancer Institute | Boston | Massachusetts | 02115 | United States |
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| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D000077156 | Gefitinib |
| ID | Term |
|---|---|
| D011799 | Quinazolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |