E7070, Idarubicin and Cytarabine in Relapsed AML and High-Risk Myelodysplastic Syndromes
Condition: Leukemia
MeSH terms: Leukemia; Preleukemia; Myelodysplastic Syndromes
Intervention: E7070; Idarubicin; Cytarabine; Dexamethasone
Intervention description: 400 mg/m2 intravenously over 1 hour on Day 1 and Day 8 every 3 weeks.; 8 mg/m2 by vein over 1 hour daily for 3 days (Days 9-11).; 1.0 g/m2 by vein daily on Days 9 - 12 (age <60 years) or Days 9 - 11 (age > 60 years).; 10 mg by vein daily for 3 - 4 days with cytarabine.
Intervention MeSH terms: Cytarabine; Dexamethasone; Idarubicin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 43.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Leukemia; Acute Myeloid Leukemia; Acute Myelogenous Leukemia; AML; Relapsed or Refractory; High-Risk Myelodysplastic Syndromes; HRMDS; E7070; Idarubicin; Idamycin; Cytarabine; Cytarabine (ARA-C); Cytosar; DepoCyt; Cytosine Arabinosine Hydrochloride; Dexamethasone; Decadron

Summary:

      The goal of this clinical research study is to learn if E7070 in combination with idarubicin,
      cytarabine, and dexamethasone can help to control the disease in patients with either AML or
      high-risk MDS that has relapsed. The safety of the drug combination will also be studied.
    

Eligibility criteria:

        Inclusion Criteria:

          1. All patients with histologically or cytologically confirmed relapsed or refractory
             acute myeloid leukemia (AML) [except acute promyelocytic leukemia], or high-risk
             myelodysplastic syndrome (HRMDS) (Int-2 high risk by International Prostate Symptom
             Score (IPSS) or >10% blasts in marrow).

          2. Patients must be 18 years or older.

          3. Patients must have a performance status of 0-2 (Zubrod scale).

          4. Patients must have adequate renal function (serum creatinine less than or equal to 1.3
             mg/dL and/or creatinine clearance > 40 mL/min). Patients with renal dysfunction due to
             organ infiltration by disease may be eligible after discussion with the Principal
             Investigator (PI) (up to creatinine less than or equal to 2.0), and appropriate dose
             adjustments will be considered.

          5. Patients must have adequate hepatic function (bilirubin less than or equal to 2.0
             mg/dl; SGOT or Serum glutamic pyruvic transaminase (SGPT) less than or equal to 3
             times the ULN for the reference lab unless due to leukemia or congenital hemolytic
             disorder or bilirubin). Patients with hepatic dysfunction (SGOT/SGPT up to less than
             or equal to 5 X ULN) due to organ infiltration by disease may be eligible after
             discussion with the PI, and appropriate dose adjustments will be considered.

          6. Patients must have normal cardiac ejection fraction

          7. QTc interval </= 480 msecs.

          8. Patients must sign an informed consent form indicating that they are aware of the
             investigational nature of this study, in keeping with the policies of the hospital.

          9. Female patients must not be pregnant or lactating. Female patients of childbearing
             potential (including those <1 year post-menopausal) and male patients must agree to
             use contraception.

        Exclusion Criteria:

          1. Patients must not have untreated or uncontrolled life-threatening infection.

          2. Patients must not have received chemotherapy and/or radiation therapy within 2 weeks.
             Hydroxyurea is allowed up to 48 hours prior to starting therapy in the setting of
             rapidly proliferating disease. Use of hydroxyurea to control proliferative disease
             will be allowed starting from day 2 until day 7 Cycle 1. Maximum dose of hydroxyurea
             allowed daily is 5 gram and hydroxyurea must be discontinued once administration of
             idarubicin and cytarabine is started.

          3. Any other medical condition, including mental illness or substance abuse, deemed by
             the PI to be likely to interfere with a patient's ability to sign informed consent or
             cooperate and participate in the study or with the interpretation of the results.

          4. Patients must not have received an investigational anti-cancer drug within two weeks
             of E7070 administration.