Trial of Arsenic Trioxide With Ascorbic Acid in the Treatment of Adult Non-Acute Promyelocytic Leukemia (APL) Acute Myelogenous Leukemia
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.
Acute Myelogenous Leukemia
Drug: Arsenic Trioxide (ATO)
Drug: Ascorbic Acid
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Trial of Arsenic Trioxide With Ascorbic Acid in the Treatment of Adult Non-APL Acute Myelogenous Leukemia|
- Number of Participants With a Response (Complete Remissions (CR) and Complete Remission With Incomplete Blood Count Recovery (CRi) [ Time Frame: Up to 1 year ] [ Designated as safety issue: No ]Complete Remission (CR): ANC >=1000/mcl, Platelet count >=100,000/mcl, Bone marrow <5% blasts. Complete Remission with incomplete blood count recovery (CRi): Same as CR but ANC may be <1,000/mcl and/or platelet count <100,000/mcl. Patients who failed to achieve CR or CRi after two cycles were considered treatment failures. Patients who did not complete at least two cycles were not evaluated for response.
- Number of Participants With Severe (Grades 3-5) Adverse Events [ Time Frame: Days 1, 8, 15, 21, 28, 35 of each cycle and at end of treatment (30 days after last dose or start of new therapy) ] [ Designated as safety issue: Yes ]Patients who received any amount of ATO plus Ascorbic Acid are included in the safety analyses.
|Study Start Date:||April 2002|
|Study Completion Date:||August 2011|
|Primary Completion Date:||June 2009 (Final data collection date for primary outcome measure)|
Experimental: Arsenic Trioxide (ATO) Plus Ascorbic acid
Arsenic Trioxide (ATO) given at 0.25 mg/kg/day intravenously for 25 days over a 35-day period.
Ascorbic Acid given at 1000 mg/day intravenously every other day that ATO is given
Drug: Arsenic Trioxide (ATO)
Arsenic Trioxide .25 mg/kg/dayDrug: Ascorbic Acid
Ascorbic Acid 1000 mg every other day for 25 days
Other Name: Vitamin C
Please refer to this study by its ClinicalTrials.gov identifier: NCT00184054
|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|