Ignite Creation Date:
2024-05-05 @ 11:57 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00184054
Status:
TERMINATED
Last Update Posted:
2014-07-25
First Post:
2005-09-12
Brief Title:
Trial of Arsenic Trioxide With Ascorbic Acid in the Treatment of Adult Non-Acute Promyelocytic Leukemia APL Acute Myelogenous Leukemia
Sponsor:
University of Southern California
Organization:
University of Southern California
Study Overview
Official Title:
Phase II Trial of Arsenic Trioxide With Ascorbic Acid in the Treatment of Adult Non-APL Acute Myelogenous Leukemia
Status:
TERMINATED
Status Verified Date:
2014-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Competing studies
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None