Status:
TERMINATED
Trial of Arsenic Trioxide With Ascorbic Acid in the Treatment of Adult Non-Acute Promyelocytic Leukemia (APL) Acute Myelogenous Leukemia
Lead Sponsor:
University of Southern California
Conditions:
Acute Myelogenous Leukemia
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This clinical research study is for patients with acute myelogenous leukemia (in short AML) that did not respond to previous treatment or unable to receive chemotherapy. Arsenic has been used as a dr...
Eligibility Criteria
Inclusion
- 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 following criteria:
- 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.
Exclusion
- 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 III, LBBB).
- 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 physician.
- 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.
Key Trial Info
Start Date :
April 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2011
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT00184054
Start Date
April 1 2002
End Date
August 1 2011
Last Update
July 25 2014
Active Locations (1)
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1
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, United States, 90032