Acute Leukemia
Conditions
Keywords
Pediatric refractory or relapsed acute leukemia
Brief summary
The purpose of this study is to determine the maximum tolerable dose of irinotecan in combination with etoposide, cytarabine for refractory or relapsed acute leukemia in pediatric patient.
Interventions
DRUGIrinotecan
Chemotherapy: irinotecan, etoposide, and cytarabine daily for 5 days (on days 0, 1, 2, 3, & 4) -30 min: Atropin ivs 0 hour: irinotecan X mg/m2 in D5W 100 mL IV over 60 min 0 hour: etoposide 100 mg/m2 in x3 N/S mL IV over 60 min 12 hour: cytarabine 2,000 mg/m2 over 3 hr \*if age ≤ 3 yrs: calculate all drugs in kg base (30kg=1m2) Irinotecan dose is escalated by 25-30% in successive cohorts. The starting irinotecan dose (level 1) is 20 mg/m2/dose on days 0 to 4.
Sponsors
Seoul National University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 21 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosis of ALL or AML. * Prior therapy Patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study. * ALL patients must have had two or more prior therapeutic attempts defined as * Persistent (BM blast\>5%) initial disease after two induction attempts, or * Persistent (BM blast\>5%) after re-induction attempt for first relapse or * Relapse after one re-induction attempt (2nd relapse) * AML patients must have one or more prior therapeutic attempts defined as * Refractory (BM blast\>20%) initial disease after one induction attempts, or * Persistent (BM blast\>5%) initial disease after two induction attempts, or * Relapse after one induction attempt (1st relapse) * Relapse after stem cell transplant: Patients are eligible 12 weeks after allogeneic stem cell transplant as long as patients are not actively being treated for GvHD and have recovered from transplant-related toxicities. Patients are eligible 8 weeks from the day of stem cell infusion for myeloablative autologous stem cell transplant, if hematological and all other eligibility criteria are met. * Age: ≤ 21 years. * Performance status: ECOG 0-2. * Patients must be free of significant functional deficits in major organs, but the following eligibility criteria may be modified in individual cases. 1. Heart: a shortening fraction ≥ 28% 2. Liver: total bilirubin \< 2 × upper limit of normal; ALT \< 3 × upper limit of normal. 3. Kidney: creatinine \<2 × normal or a creatinine clearance (GFR) \> 60 ml/min/1.73m2. * Patients must lack any active viral infections or active fungal infection. * Patients (or one of parents if patients age \< 19) should sign informed
Exclusion criteria
1. Pregnant or nursing women. 2. Malignant (except acute leukemia) or nonmalignant illness that is uncontrolled or whose control may be jeopardized by complications of study therapy. 3. Psychiatric disorder that would preclude compliance. 4. Patients who, in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine the maximum tolerable dose of irinotecan in combination with etoposide, cytarabine for refractory or relapsed acute leukemia in pediatric patient. | 28 days |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the incidence and severity of toxicity and treatment related mortality. 2. To evaluate the response rate. 3. To determine the pharmacokinetic profile of irinotecan in combination with etoposide, cytarabine in pediatric patients. | 2 years |
Countries
South Korea
Contacts
Primary ContactHyoung Jin Kang, M.D, Ph.D
Backup ContactJi Won Lee, M.D
Outcome results
None listed