Multicenter Study of 9-Aminocamptothecin (9-AC) in Patients With Refractory Leukemia

Study Overview
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Brief Summary
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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
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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.

Official Title
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Multicenter Study of 9-AC in Refractory Leukemia

Conditions
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Leukemia, Myelocytic, Acute, Acute Lymphocytic Leukemia

Intervention / Treatment
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* Drug: 9-Aminocamptothecin (9-AC)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: 9-Aminocamptothecin (9-AC)|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To analyze the pharmacokinetics in these patients. |  | years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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leukemia, 9-Aminocamptothecin, AML, ALL, refractory leukemia, relapsed leukemia