Multicenter Study of 9-AC in Refractory Leukemia
- The treatment patients will receive involves a continuous infusion of 9-AC
intravenously for a 72 hour period. Since we are unsure of the safest and most
effective dose, successive groups of 4-7 patients will receive larger doses of this
drug until the largest dose given safely is established.
- Prior to the start of therapy a bone marrow aspirate and biopsy will be taken for
diagnostic and research purposes. A bone marrow exam will be repeated at 48 hours in
order to determine the effects of 9-AC on leukemic cells in the bone marrow. A bone
marrow scan will also be performed 14 days after the start of therapy to assess
- Frequent blood testing will be done throughout treatment, including blood samples to
determine the levels of the 9-AC in the blood.
- Treatment could be stopped prematurely if any of the following occur: 1) drug causes
severe side effects, 2) the drug does not control the leukemia, or 3) the doctors or
the patient feel that it is no longer in the patients best interest to receive this
- Approximately 7 days after the conclusion of the 9-AC infusion, it is likely that the
patient's blood counts will be low and will require support with antibiotics, red cell
transfusions and platelet transfusions.
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To evaluate the toxicity and maximum tolerated dose of 9-AC administered as a 72 hour infusion in patients with relapsed/refractory leukemia.
Richard Stone, MD
Dana-Farber Cancer Institute
United States: Food and Drug Administration
|Dana-Farber Cancer Institute||Boston, Massachusetts 02115|
|Massachusetts General Hosptial||Boston, Massachusetts 02114|