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

Phase 1

Completed

• Conditions: Acute Lymphocytic Leukemia; Leukemia, Myelocytic, Acute

• Registration Number: NCT00251368
• Lead Sponsor: Dana-Farber Cancer Institute

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.

Study Timeline

• Study Start: 1995-01
• Study First Submitted: 2005-11-08
• Study First Submitted QC: 2005-11-08
• Study First Posted: 2005-11-10
• Primary Completion: 2007-09
• Study Completion: 2007-09
• Status Verified: 2011-03
• Last Update Submitted: 2011-03-09
• Last Update Posted: 2011-03-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

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

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Exclusion Criteria

• Undergone bone marrow transplantation
• Uncontrolled infection
• Other active malignancy
• HIV positivity
• Serious medical or psychiatric illness
• Pregnancy

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
To analyze the pharmacokinetics in these patients.	years

Trial Locations

Locations (2)

Massachusetts General Hosptial; 🇺🇸 Boston, Massachusetts, United States

Dana-Farber Cancer Institute; 🇺🇸 Boston, Massachusetts, United States