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

Acute Lymphocytic Leukemia Clinical Trial

Official title:

Multicenter Study of 9-AC in Refractory Leukemia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00251368
• Other study ID #: 94-115
• Status: Completed
• Phase: Phase 1
• First received: November 8, 2005
• Last updated: March 9, 2011
• Start date: January 1995
• Est. completion date: September 2007

Study information

• Verified date: March 2011
• Source: Dana-Farber Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: September 2007
• Est. primary completion date: September 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Lymphocytic Leukemia
• Leukemia
• Leukemia, Lymphoid
• Leukemia, Myelocytic, Acute
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

Intervention

Drug:
• 9-Aminocamptothecin (9-AC)

Locations

Country	Name	City	State
United States	Dana-Farber Cancer Institute	Boston	Massachusetts
United States	Massachusetts General Hosptial	Boston	Massachusetts

Sponsors (4)

Lead Sponsor	Collaborator
Dana-Farber Cancer Institute	Beth Israel Deaconess Medical Center, Brigham and Women's Hospital, Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	To analyze the pharmacokinetics in these patients.		years