Acute Lymphocytic Leukemia, Leukemia, Myelocytic, Acute
Conditions
Keywords
leukemia, 9-Aminocamptothecin, AML, ALL, refractory leukemia, relapsed leukemia
Brief summary
The purpose of this study is to evaluate the side effects of 9-Aminocamptothecin (9-AC) and to determine the best dose which should be used to treat leukemia.
Detailed description
* 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 response. * 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 therapy. * 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.
Interventions
DRUG9-Aminocamptothecin (9-AC)
Sponsors
Brigham and Women's Hospital
Beth Israel Deaconess Medical Center
Massachusetts General Hospital
Dana-Farber Cancer Institute
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 18 years of age or older * AML or ALL in first or subsequent relapse, secondary AML, or CML in blastic phase * Central venous access * ECOG performance status of less than or equal to 2 * Bilirubin \< 1.3 * SGOT \< 2 x ULN * Alkaline phosphatase \< 2 x ULN * Creatinine \< 1.5
Exclusion criteria
* Undergone bone marrow transplantation * Uncontrolled infection * Other active malignancy * HIV positivity * Serious medical or psychiatric illness * Pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the toxicity and maximum tolerated dose of 9-AC administered as a 72 hour infusion in patients with relapsed/refractory leukemia. | Years |
Secondary
| Measure | Time frame |
|---|---|
| To analyze the pharmacokinetics in these patients. | years |
Countries
United States
Outcome results
None listed