Phase 2 Study of Temozolomide to Treat Poor Risk / Refractory Acute Myeloid Leukemia

Not Recruiting

Trial ID: NCT00611247


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

Official Title

Phase II Study of Two Distinct Tailored Temozolomide Regimens for Patients With Acute Myeloid Leukemia Age > 60 Years and Poor Risk/Refractory Disease

Stanford Investigator(s)

James L. Zehnder, M.D.
James L. Zehnder, M.D.

Professor of Pathology (Research) and of Medicine (Hematology)

Jason Gotlib

Professor of Medicine (Hematology)


Inclusion Criteria:

   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[3])

      - 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.

Exclusion Criteria:

   1. Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for
   nitrosoureas or mitomycin C) prior to entering the study or those who have not
   recovered from adverse events due to agents administered more than 4 weeks earlier.

   2. Patients may not be receiving any other investigational agents.

   3. History of allergic reactions attributed to compounds of similar chemical or biologic
   composition to temozolomide or DTIC

   4. History of gastrointestinal disease or significant bowel resection that could
   interfere with drug absorption.

   5. Uncontrolled intercurrent illness including, but not limited to, ongoing or active
   infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
   arrhythmia, or psychiatric illness/social situations that would limit compliance with
   study requirements.

   6. Prior allogeneic stem cell transplantation.

   7. Inability to swallow tablets

   8. Prior radiation up to more than 25% of bone marrow.


drug: Temozolomide

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Richa Rajwanshi

New Trial Alerts