Study of IRNEA (Irinotecan, Etoposide, Cytarabine) for Refractory or Relapsed Acute Leukemia in Children and Adolescents
NCT ID: NCT01239485
Last Updated: 2013-11-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1
18 participants
INTERVENTIONAL
2010-11-30
2013-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Irinotecan
Irinotecan
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.
Interventions
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Irinotecan
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.
Eligibility Criteria
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Inclusion Criteria
* 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
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.
21 Years
ALL
No
Sponsors
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Seoul National University Hospital
OTHER
Responsible Party
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Korea Childhood Leukemia Foundation
Principal Investigators
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Hyoung Jin Kang, M.D, ph.D
Role: PRINCIPAL_INVESTIGATOR
Seoul National University Hospital
Locations
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Seoul National University Hospital
Seoul, Chongno-gu, South Korea
Countries
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Central Contacts
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Facility Contacts
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Hyoung Jin Kang, M.D, Ph.D
Role: primary
Other Identifiers
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SCLSG-0901, SNUCH-RAL-0901
Identifier Type: -
Identifier Source: org_study_id