Clinical trial NCT00251368: Multicenter Study of 9-Aminocamptothecin (9-AC) in Patients With Refractory Leukemia
Official title: Multicenter Study of 9-AC in Refractory Leukemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Leukemia, Myelocytic, Acute
Acute Lymphocytic Leukemia
Keywords: leukemia
9-Aminocamptothecin
AML
ALL
refractory leukemia
relapsed leukemia
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
Collaborators: name: Brigham and Women's Hospital
name: Beth Israel Deaconess Medical Center
name: Massachusetts General Hospital
First posted: 2005-11-10
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: To evaluate the toxicity and maximum tolerated dose of 9-AC administered as a 72 hour infusion in patients with relapsed/refractory leukemia.
timeFrame: Years
Secondary outcomes:
measure: To analyze the pharmacokinetics in these patients.
timeFrame: years
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hosptial
state: Massachusetts
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
Study officials:
affiliation: Dana-Farber Cancer Institute
name: Richard Stone, MD
role: PRINCIPAL_INVESTIGATOR
References: