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Sponsored by: |
Norris Comprehensive Cancer Center |
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Information provided by: | Norris Comprehensive Cancer Center |
ClinicalTrials.gov Identifier: | NCT00184054 |
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 drug for many centuries. While arsenic containing drugs were used in the past for cancer treatments, the major use of arsenic in western countries has been for the treatment of uncommon tropical illnesses, such as sleeping sickness. Recently, some new information suggests that arsenic in a form called arsenic trioxide may also be useful to treat some cancers of the blood, such as leukemia, lymphoma and myeloma. Studies from China and the USA showed that patients with a type of blood cancer called acute promyelocytic leukemia, whose disease failed to respond to other treatments, responded very well to arsenic trioxide. Studies done in laboratories in the United States have shown that arsenic can kill AML cells growing in culture dishes.
Ascorbic acid (vitamin C), a natural supplement in our diet, has long been involved with cancer prevention. Laboratory tests have shown that although arsenic trioxide by itself can kill AML cells in the test tube, when vitamin C is added to arsenic trioxide in a test tube, the death of the leukemia cells increases significantly.
The purpose of this study is to find out if the combination of arsenic trioxide (Trisenox) and ascorbic acid is effective in the treatment of patients who have AML. The second purpose is to study how the two drugs affect cells in the laboratory. Samples from the blood and bone marrow (the part of the body that makes blood cells) will be collected, at specific times during treatment, in order to study them in the laboratory. By studying blood and marrow cells, researchers hope to learn the mechanisms by which the drugs work.
Condition | Intervention | Phase |
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Acute Myelogenous Leukemia |
Drug: Arsenic Trioxide and Ascorbic Acid |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Phase II Trial of Arsenic Trioxide With Ascorbic Acid in the Treatment of Adult Non-APL Acute Myelogenous Leukemia |
Estimated Enrollment: | 15 |
Study Start Date: | April 2002 |
Study Completion Date: | June 2008 |
Primary Completion Date: | June 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental |
Drug: Arsenic Trioxide and Ascorbic Acid
Arsenic Trioxide .25 mg/kg/day Ascorbic Acid 100 mg per day Both during induction, consolidation and maintenance |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
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:
Exclusion Criteria:
Newly diagnosed patients older than age 55 who:
United States, California | |
USC/Norris Comprehensive Cancer Center and Hospital | |
Los Angeles, California, United States, 90032 |
Principal Investigator: | Dan Douer, MD | University of Southern California |
Responsible Party: | University of Southern California ( Dan Douer, MD ) |
Study ID Numbers: | 9L-02-1 |
Study First Received: | September 12, 2005 |
Last Updated: | December 29, 2008 |
ClinicalTrials.gov Identifier: | NCT00184054 |
Health Authority: | United States: Institutional Review Board |
Leukemia Acute promyelocytic leukemia Acute myelogenous leukemia Leukemia, Promyelocytic, Acute Arsenic trioxide |
Leukemia, Myeloid Leukemia, Myeloid, Acute Acute myelocytic leukemia Ascorbic Acid |
Neoplasms Antioxidants Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Therapeutic Uses |
Growth Substances Vitamins Physiological Effects of Drugs Micronutrients Protective Agents Pharmacologic Actions |