L-Ascorbic Acid Depletion to Treat Acute Myeloid Leukemia and Myelodysplastic Syndromes

• Status: Suspended
• Trial end date: 2005-08-01
• Target enrollment: 0
• Participant gender: All

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 chemorefractory patients with acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Samsung Medical Center
• Collaborator: Jin Yang Pharmaceutical
• Treatments: Ascorbic Acid

Criteria

Inclusion Criteria:

• 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 Criteria:

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