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

Sponsor

Dana-Farber Cancer Institute (Other)

Overall Status

Completed

CT.gov ID

NCT00251368

Collaborator

Brigham and Women's Hospital (Other), Beth Israel Deaconess Medical Center (Other), Massachusetts General Hospital (Other)

Enrollment

Locations

152

Duration (Months)

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Leukemia, Myelocytic, Acute Acute Lymphocytic Leukemia	Drug: 9-Aminocamptothecin (9-AC)	Phase 1

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 Design

Study Type:

Interventional

Anticipated Enrollment :

52 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Multicenter Study of 9-AC in Refractory Leukemia

Study Start Date :

Jan 1, 1995

Actual Primary Completion Date :

Sep 1, 2007

Actual Study Completion Date :

Sep 1, 2007

Outcome Measures

Primary Outcome Measures

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

To analyze the pharmacokinetics in these patients. [years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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