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

Phase 2
60 Years
Not Enrolling
Leukemia, Myeloid

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Trial Information

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

This is a single institution phase II clinical trial (no control arm) to evaluate the
efficacy, safety and tolerability of tailored temozolomide therapy for patients with acute
myeloid leukemia (AML) and poor risk features.

Patients will have methylation status of AGAT promoter region determined by PCR. Patients
will be assigned to one of the two treatment groups depending on methylation status.
Temozolomide will be given orally for 7 or 21 days, accordingly (induction phase).

Patients achieving a complete remission after one or two cycles of chemotherapy will be
eligible to receive up to an additional 5 cycles of temozolomide for 5 or 19 days, depending
on the methylation status of the AGAT promoter (consolidation phase).

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

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.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To determine the clinical efficacy of 2 different treatment regimens of temozolomide in patients with AML and poor prognostic features

Outcome Time Frame:

2 months

Safety Issue:


Principal Investigator

Bruno Carneiro de Medeiros

Investigator Role:

Principal Investigator

Investigator Affiliation:

Stanford University


United States: Institutional Review Board

Study ID:




Start Date:

December 2007

Completion Date:

January 2010

Related Keywords:

  • Leukemia, Myeloid
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid



Stanford University School of Medicine Stanford, California  94305-5317