Phase I Study of IRNEA (Irinotecan, Etoposide, Cytarabine) for Refractory or Relapsed Acute Leukemia in Children and Adolescents

Seoul National University Hospital1 site in 1 country18 target enrollmentNovember 2010

ConditionsAcute Leukemia

InterventionsIrinotecan

DrugsIrinotecan

Overview

Phase: Phase 1
Intervention: Irinotecan
Conditions: Acute Leukemia
Sponsor: Seoul National University Hospital
Enrollment: 18
Locations: 1
Primary Endpoint: To determine the maximum tolerable dose of irinotecan in combination with etoposide, cytarabine for refractory or relapsed acute leukemia in pediatric patient.
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

November 2010

End Date

December 2013

Last Updated

12 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Seoul National University Hospital

Eligibility Criteria

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)

Exclusion Criteria

•Pregnant or nursing women.
•Malignant (except acute leukemia) or nonmalignant illness that is uncontrolled or whose control may be jeopardized by complications of study therapy.
•Psychiatric disorder that would preclude compliance.
•Patients who, in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study.

Arms & Interventions

Irinotecan

Intervention: Irinotecan

Outcomes

Primary Outcomes

To determine the maximum tolerable dose of irinotecan in combination with etoposide, cytarabine for refractory or relapsed acute leukemia in pediatric patient.

Time Frame: 28 days

Secondary Outcomes

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)