Erlotinib Hydrochloride in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia
Condition: Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome; Adult Acute Myeloid Leukemia With Inv(16)(p13.1q22); CBFB-MYH11; Adult Acute Myeloid Leukemia With t(16;16)(p13.1;q22); CBFB-MYH11; Adult Acute Myeloid Leukemia With t(8;21); (q22; q22.1); RUNX1-RUNX1T1; Adult Acute Myeloid Leukemia With t(9;11)(p22.3;q23.3); MLLT3-KMT2A; Adult Acute Promyelocytic Leukemia With PML-RARA; Alkylating Agent-Related Acute Myeloid Leukemia; Chronic Myelomonocytic Leukemia; Myelodysplastic Syndrome; Previously Treated Myelodysplastic Syndrome; Recurrent Adult Acute Myeloid Leukemia
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute; Preleukemia; Leukemia, Myelomonocytic, Chronic; Leukemia, Myelomonocytic, Juvenile; Leukemia, Promyelocytic, Acute; Myelodysplastic Syndromes; Syndrome
Intervention: Erlotinib Hydrochloride; Laboratory Biomarker Analysis
Intervention description: Given PO; Correlative studies
Intervention MeSH terms: Erlotinib Hydrochloride
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 29.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This pilot phase II trial studies how well erlotinib hydrochloride works in treating patients
      with relapsed or refractory acute myeloid leukemia. Erlotinib hydrochloride may stop the
      growth of cancer cells by blocking some of the enzymes needed for cell growth.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with AML who have either been refractory to prior therapy or have relapsed
             after prior therapy; patients with myelodysplastic syndromes (MDS) or chronic
             myelomonocytic leukemia (CMML) who received therapy with a hypomethylating agent and
             progress to AML are eligible if they have received any therapy for MDS and failed
             (i.e., lack or loss of response) regardless of whether they have received therapy for
             AML or not; the World Health Organization (WHO) classification will be used for AML

          -  Eastern Cooperative Oncology Group (ECOG) performance status =< 2

          -  Total bilirubin =< 2 x upper limit of normal (ULN)

          -  Alanine aminotransferase (ALT) =< 2.5 x ULN

          -  Creatinine =< 2 x ULN

          -  Patients must provide written informed consent

          -  Patients must have been off chemotherapy for 2 weeks prior to entering this study,
             unless there is evidence of rapidly progressive disease, and must have recovered from
             the clinically significant toxic effects of that therapy to at least grade 1; use of
             hydroxyurea for patients with rapidly proliferative disease is allowed before the
             start of study therapy and for the first four weeks on therapy

          -  Patients-both males and females-with reproductive potential (i.e., menopausal for less
             than 1 year and not surgically sterilized) must practice effective contraceptive
             measures throughout the study; women of childbearing potential must provide a negative
             pregnancy test (serum or urine) within 14 days prior to initiation of study

        Exclusion Criteria:

          -  Patients with known allergy or hypersensitivity to erlotinib

          -  Patients with any other known disease (except carcinoma in-situ) concurrent severe
             and/or uncontrolled medical condition (e.g. uncontrolled diabetes; cardiovascular
             disease including congestive heart failure New York Heart Association [NYHA] class III
             or IV, myocardial infarction within 6 months, and poorly controlled hypertension;
             chronic renal failure; or active uncontrolled infection) which, in the opinion of the
             investigator could compromise participation in the study

          -  Patients unwilling or unable to comply with the protocol

          -  Significant gastrointestinal disorders that may interfere with absorption of erlotinib

          -  Patients who can receive a stem cell transplant within 4 weeks