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Phase II Trial of Arsenic Trioxide With Ascorbic Acid in the Treatment of Adult Non-APL Acute Myelogenous Leukemia


Phase 2
18 Years
N/A
Not Enrolling
Both
Acute Myelogenous Leukemia

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Trial Information

Phase II Trial of Arsenic Trioxide With Ascorbic Acid in the Treatment of Adult Non-APL Acute Myelogenous Leukemia


Inclusion Criteria:



- 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 Criteria:

- 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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response (Complete Remission, Complete Remission [platelet], Partial Remission, and Progression)

Outcome Time Frame:

6 months after enrollment of last participant

Safety Issue:

No

Principal Investigator

Dan Douer, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Southern California

Authority:

United States: Institutional Review Board

Study ID:

9L-02-1

NCT ID:

NCT00184054

Start Date:

April 2002

Completion Date:

August 2011

Related Keywords:

  • Acute Myelogenous Leukemia
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid
  • Leukemia, Promyelocytic, Acute

Name

Location

USC/Norris Comprehensive Cancer Center and HospitalLos Angeles, California  90033-0804