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A Phase II Study of Low Dose Arsenic Trioxide in Patients With Malignancies as a Potential Chemotherapy Protector

Phase 2
18 Years
Not Enrolling
Cancer Other Than Leukemia

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Trial Information

A Phase II Study of Low Dose Arsenic Trioxide in Patients With Malignancies as a Potential Chemotherapy Protector

Inclusion Criteria:

1. Patients ≥ 18 years of age with the diagnosis of malignancy other than leukemia who
are to start chemotherapy known to suppress peripheral blood counts. The expected
interval between each cycle of chemotherapy should be a minimum of 2 weeks. The
minimum number of planned chemotherapy cycles should be 4. Radiation therapy during
chemotherapy is allowed as long as less than 10% of the total bone marrow is

2. Present with or without previous treatment for the disease.

3. ECOG performance status
4. Life expectancy of greater than 6 months

5. Organ functions as deemed appropriate for chemotherapy per standard of care

6. Agree to use adequate contraception prior to study entry and for the duration of
study participation.

7. Ability to understand and the willingness to sign a written informed consent

8. No baseline p53 activation in peripheral lymphocytes in culture but p53 activation
should be inducible upon radiation with 2 Gy in culture

Exclusion Criteria:

1. History of allergic reactions attributed to Arsenic Trioxide

2. Experiencing uncontrolled inter-current 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.

3. Pregnant

4. HIV-positive patients and taking combination antiretroviral therapy.

5. History of having circulating malignant cells if the patient has lymphoma or myeloma

6. Impaired cardiac function or clinically significant cardiac diseases, including any
of the following: history of long QT syndrome; mean QTc > 500 msec on screening EKG;
history of clinically manifest ischemic heart disease including myocardial
infarction; stable or unstable angina, coronary arteriography or cardiac stress
testing/imaging with findings consistent with coronary occlusion or infarction < 6
months prior to study start; history of heart failure or left ventricular (LV)
dysfunction (LVEF < 45%) by MUGA or ECHO; clinically significant EKG abnormalities
including one or more of the following: left bundle branch block (LBBB), right bundle
branch block (RBBB) with left anterior hemiblock (LAHB). ST segment elevations or
depressions > lmm, or 2nd (Mobitz 11) or 3rd degree AV block; history or presence of
atrial fibrillation, atrial flutter or ventricular arrhythmias including ventricular
tachycardia or Torsades de Pointes; other clinically significant heart disease (e.g.
congestive heart failure, uncontrolled hypertension, history of labile hypertension,
or history of poor compliance with an antihypertensive regimen); clinically
significant resting bradycardia (< 50 beats per minute); obligate use of a cardiac

Type of Study:


Study Design:

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

Outcome Measure:

Decrease in p53 protein production

Outcome Description:

A main objective of this trial is to find the dose of arsenic that blocks the activation of p53. Blocakage will reduce the amount of p53 production as measured by Western Blot.

Outcome Time Frame:

Day 1 of chemotherapy

Safety Issue:


Principal Investigator

Chul S. Ha, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

The University of Texas Health Science Center at San Antonio


United States: Institutional Review Board

Study ID:




Start Date:

April 2011

Completion Date:

January 2013

Related Keywords:

  • Cancer Other Than Leukemia
  • Leukemia



The University of Texas Health Science Center at San AntonioSan Antonio, Texas  78229