Status:
SUSPENDED
L-Ascorbic Acid Depletion to Treat Acute Myeloid Leukemia and Myelodysplastic Syndromes
Lead Sponsor:
Samsung Medical Center
Collaborating Sponsors:
Jin Yang Pharmaceutical
Conditions:
Acute Myeloid Leukemia
Myelodysplastic Syndrome
Eligibility:
All Genders
Phase:
PHASE2
Brief Summary
To document therapeutic gain achieved by cyclic application of L-ascorbic acid (LAA) supplementation and depletion, while confirming safety and avoidance of clinically significant scurvy, in chemorefr...
Detailed Description
The seminal discovery that the in vitro growth of malignant cells could be absolutely dependent on L-ascorbic acid (LAA) was originally published in Sciene. The cell culture assay used with a mouse pl...
Eligibility Criteria
Inclusion
- Patients should have AML or MDS according to new WHO classification, with minimum of 5% blasts in peripheral blood.
- There must be a clear and acceptable reason for not receiving standard treatments (chemotherapy and/or stem cell transplantation); or standard treatments have already been given and this option exhausted with evidence of refractory disease.
- Prior treatments of any forms are allowed provided there is no potential residual beneficial effect and the patients are off treatment for at least 4 weeks, with estimated life expectancy of at least 2 months.
- Adequate amount (4 ml) of bone marrow sent to the laboratory for cell culture studies.
- There are no restrictions based on age, sex, or ethnicity except that adequate contraception must be practiced in women of childbearing ages. Although AML is rare in children, pediatric patients will be accepted.
- There is no deficiency of G6PD (RBC).
- Asymptomatic patients with disease progression and symptomatic patients.
Exclusion
- \-
Key Trial Info
Start Date :
May 1 1998
Trial Type :
INTERVENTIONAL
End Date :
August 1 2005
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT00329498
Start Date
May 1 1998
End Date
August 1 2005
Last Update
October 26 2006
Active Locations (1)
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1
Samsung Medical Center
Seoul, South Korea