Status:
COMPLETED
Phase 2 Study of Temozolomide to Treat Poor Risk / Refractory Acute Myeloid Leukemia
Lead Sponsor:
Bruno C. Medeiros
Collaborating Sponsors:
Schering-Plough
Conditions:
Leukemia, Myeloid
Eligibility:
All Genders
60+ years
Phase:
PHASE2
Brief Summary
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
Detailed Description
This is a single institution phase 2 clinical trial evaluating the efficacy, safety, and tolerability of tailored temozolomide therapy for patients with acute myeloid leukemia (AML) and poor risk feat...
Eligibility Criteria
Inclusion
- Patients must have histologically or cytologically confirmed Acute Myeloid Leukemia, as defined by the WHO classification.
- Patients must be considered unfit for conventional induction chemotherapy, unwilling to receive such treatment or have evidence of disease relapse or refractory disease.
- 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).
- Age \> 60 years of age.
- Life expectancy of greater than 3 months.
- ECOG performance status greater than 2.
- Patients must have normal organ and marrow function as defined below:
- Adequate hepatic function: Total bilirubin 1.5mg/dL, AST(SGOT)/ALT(SGPT) 2.5 X institutional upper limit of normal.
- 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.
- Ability to understand and the willingness to sign a written informed consent document.
Exclusion
- 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.
- Patients may not be receiving any other investigational agents.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to temozolomide or DTIC
- History of gastrointestinal disease or significant bowel resection that could interfere with drug absorption.
- 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.
- Prior allogeneic stem cell transplantation.
- Inability to swallow tablets
- Prior radiation up to more than 25% of bone marrow.
Key Trial Info
Start Date :
December 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2010
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT00611247
Start Date
December 1 2007
End Date
January 1 2010
Last Update
June 15 2018
Active Locations (1)
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1
Stanford University School of Medicine
Stanford, California, United States, 94305