Acute Myeloid Leukemia (AML) Clinical Trial
Official title:
A Phase I/Phase II Evaluation of Laromustine (VNP40101M), A Sulfonylhydrazine Alkylating Agent, Combined With Infusional Cytarabine in Elderly Patients With Acute Myeloid Leukemia and High Risk Myelodysplastic Syndrome
- The purpose of the Phase I portion of this study is to evaluate the safety of this
combination of medications and to determine the appropriate dose of VNP40101M to be used
in combination with infusional cytarabine (araC) in elderly patients with Acute Myeloid
Leukemia (AML) and High Risk Myelodysplastic Syndrome (MDS).
- The purpose of the Phase II portion of the study is to evaluate the effectiveness
(overall response rate) for patients treated with VNP40101M and infusional cytarabine
induction therapy.
There is no known standard chemotherapy that is considered effective for older patients with
AML or high risk MDS at this time, and with current treatment, tumor reduction can be
difficult to achieve and is short-lived. We are, therefore, interested in developing new
drugs that might have a longer-lasting effect against disease.
Laromustine is a new drug that has been shown to have anti-cancer activity in animal and
human studies. It interacts with the DNA of a cancer cell and kills the cell. Cytarabine
(AraC) is a commercially available chemotherapy drug that is active against leukemia and used
routinely when the disease is first diagnosed. In previous studies, when higher doses of
laromustine were given, laromustine and AraC achieved more responses than patients treated
with AraC alone. However, this advantage was offset by the fact that more patients given
laromustine/AraC died to due side effects. We wish to determine the effectiveness of
laromustine in combination with infusional AraC in AML and high risk MDS patients who are 60
or more years of age.
;
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