Multicenter Study of 9-Aminocamptothecin (9-AC) in Patients With Refractory Leukemia
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|ClinicalTrials.gov Identifier: NCT00251368|
Recruitment Status : Completed
First Posted : November 10, 2005
Last Update Posted : March 10, 2011
|Condition or disease||Intervention/treatment||Phase|
|Leukemia, Myelocytic, Acute Acute Lymphocytic Leukemia||Drug: 9-Aminocamptothecin (9-AC)||Phase 1|
- 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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||52 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Multicenter Study of 9-AC in Refractory Leukemia|
|Study Start Date :||January 1995|
|Actual Primary Completion Date :||September 2007|
|Actual Study Completion Date :||September 2007|
- To evaluate the toxicity and maximum tolerated dose of 9-AC administered as a 72 hour infusion in patients with relapsed/refractory leukemia. [ Time Frame: Years ]
- To analyze the pharmacokinetics in these patients. [ Time Frame: years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00251368
|United States, Massachusetts|
|Massachusetts General Hosptial|
|Boston, Massachusetts, United States, 02114|
|Dana-Farber Cancer Institute|
|Boston, Massachusetts, United States, 02115|
|Principal Investigator:||Richard Stone, MD||Dana-Farber Cancer Institute|