Phase II Study of Two Distinct Tailored Temozolomide Regimens for Patients With Acute Myeloid Leukemia Age > 60 Years and Poor Risk/Refractory Disease
Open-label, non-randomized, parallel assignment, phase 2 trial assessing the safety and efficacy of distinct temozolomide treatment regimens for patients with AML and poor prognosis
Stanford is not currently accepting new patients for this trial. You may want to check clinicaltrials.gov to see if other locations are recruiting.
- drug : Temozolomide
Phase: Phase 2
Ages Eligible For Study:
1. Patients must have histologically or cytologically confirmed Acute Myeloid Leukemia, as defined by the WHO classification. 2. Patients must be considered unfit for conventional induction chemotherapy, unwilling to receive such treatment or have evidence of disease relapse or refractory disease. 3. For patients who have received no prior conventional chemotherapy, one of the following must be present: - Poor risk cytogenetics (complex abnormalities, deletions of chromosome 7 or 5, 11q23 abnormalities, inv) - Secondary leukemia (prior hematologic disorder or therapy-related leukemia). 4. Age > 60 years of age. 5. Life expectancy of greater than 3 months. 6. ECOG performance status greater than 2. 7. Patients must have normal organ and marrow function as defined below: 8. Adequate hepatic function: Total bilirubin 1.5mg/dL, AST(SGOT)/ALT(SGPT) 2.5 X institutional upper limit of normal. 9. Adequate renal function: serum creatinine within normal institutional limits or Calculated creatinine clearance > 60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal. 10. Ability to understand and the willingness to sign a written informed consent document.