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
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.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
The objectives of this study are to evaluate the safety and efficacy of VNP40101M in combination with infusional Ara C as induction therapy in elderly patients with AML or high-risk MDS evolving to AML.
Subjects will be closely monitored continuously throughout the study.
United States: Food and Drug Administration
|Weill Cornell Medical College||New York, New York 10021|