Status:
COMPLETED
Multicenter Study of 9-Aminocamptothecin (9-AC) in Patients With Refractory Leukemia
Lead Sponsor:
Dana-Farber Cancer Institute
Collaborating Sponsors:
Brigham and Women's Hospital
Beth Israel Deaconess Medical Center
Conditions:
Leukemia, Myelocytic, Acute
Acute Lymphocytic Leukemia
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 pat...
Eligibility Criteria
Inclusion
- 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
- Undergone bone marrow transplantation
- Uncontrolled infection
- Other active malignancy
- HIV positivity
- Serious medical or psychiatric illness
- Pregnancy
Key Trial Info
Start Date :
January 1 1995
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2007
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT00251368
Start Date
January 1 1995
End Date
September 1 2007
Last Update
March 10 2011
Active Locations (2)
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1
Massachusetts General Hosptial
Boston, Massachusetts, United States, 02114
2
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115