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

NCT ID: NCT00251368

Last Updated: 2011-03-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1995-01-31
• Study Completion Date: 2007-09-30

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.

Conditions

Leukemia, Myelocytic, Acute; Acute Lymphocytic Leukemia

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

9-Aminocamptothecin (9-AC)

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Brigham and Women's Hospital

OTHER

Sponsor Role: collaborator

Beth Israel Deaconess Medical Center

OTHER

Sponsor Role: collaborator

Massachusetts General Hospital

OTHER

Sponsor Role: collaborator

Dana-Farber Cancer Institute

OTHER

Sponsor Role: lead

Principal Investigators

Richard Stone, MD

Role: PRINCIPAL_INVESTIGATOR

Dana-Farber Cancer Institute

Locations

Massachusetts General Hosptial

Boston, Massachusetts, United States

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

94-115

Identifier Type: -

Identifier Source: org_study_id