Phase II Trial of Arsenic Trioxide With Ascorbic Acid in the Treatment of Adult Non-APL Acute Myelogenous Leukemia
- Diagnosis of non-APL AML (FAB subtypes M0 - M7 but excluding M3) confirmed by
myeloperoxidase stain and/or flow cytometry.
- For patients of age 18 or older - only refractory or relapsed AML will be included.
Refractory disease is defined as newly diagnosed patients who fulfill ONE of the
- Patient aged 60 years or younger, who have failed to achieve a complete
remission after at least two cycles of front line induction chemotherapy.
- Patients of any age who have AML, that is post myelodysplastic syndrome (MDS),
who failed to achieve a complete remission after at least one cycle of front
line induction chemotherapy.
- Patients aged 60 years or older who failed to achieve a complete remission after
at least one cycle of front line induction chemotherapy.
- Newly diagnosed patients aged 55 or older who will not receive intensive
anti-leukemia chemotherapy can also be enrolled.
- Post-myelodysplasia AML and secondary AML are included.
- Stem cell transplantation failures are included.
- Karnofsky performance status greater or equal to 50%.
- Adequate renal function (creatinine < 1.5 x ULN or creatinine clearance > 60 ml/min)
and hepatic function (transaminases < 2.5 x ULN, serum total bilirubin < 3 mg/dl).
- Females of childbearing potential must have a negative serum pregnancy test prior to
enrollment on the study, and both women and men must use an effective birth control
method while on the study.
- Signed consent.
- Newly diagnosed patients older than age 55 who:
- Refuse chemotherapy when their treating physician recommends standard
anti-leukemia induction chemotherapy.
- Have a Karnofsky performance status of greater or equal to 70%, aged < 75 years
and has no prior myelodysplastic syndrome.
- Have a risk/benefit ratio that gives their treating physician good reason for
administration of standard anti-leukemia induction chemotherapy.
- Patients who have already been treated with arsenics.
- CML in blastic crisis.
- Patients with cardiopathies including recurrent supraventricular arrhythmia and any
type of sustained ventricular arrhythmia or conduction block (A-V block grade II or
- Patients with HIV.
- Pregnant or breastfeeding women.
- QT interval > 460 msec in the presence of serum potassium > 4.0 mEq/L and
magnesium > 1.8 mg/dL.
- Pre-existing neurotoxicity/neuropathy of Grade 2 or greater according to the NCI
Common Toxicity Criteria Version 2.
- History of preexisting neurological disorders (grade 3 or higher by the NCI Common
Toxicity Criteria; in particular, seizure disorders).
- Patients with an underlying medical condition that could be aggravated by the
treatment or life threatening disease unrelated to AML as evaluated by the enrolling
- Patients with active second malignancy, excluding adequately treated basal or
squamous cell carcinoma of the skin, or carcinoma in situ of the cervix.
- Inability or unwillingness to comply with the treatment protocol.