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

Sponsor

Seoul National University Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT01239485

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

0.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Leukemia	Drug: Irinotecan	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

18 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Nov 1, 2010

Anticipated Primary Completion Date :

Dec 1, 2013

Anticipated Study Completion Date :

Dec 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Irinotecan	Drug: 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.

Arm

Intervention/Treatment

Experimental: Irinotecan

Drug: 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.

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 21 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Heart: a shortening fraction ≥ 28%
Liver: total bilirubin < 2 × upper limit of normal; ALT < 3 × upper limit of normal.
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:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Seoul National University Hospital	Seoul	Chongno-gu	Korea, Republic of	110-744

Sponsors and Collaborators

Seoul National University Hospital

Investigators

Principal Investigator: Hyoung Jin Kang, M.D, ph.D, Seoul National University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT01239485

Other Study ID Numbers:

SCLSG-0901, SNUCH-RAL-0901

First Posted:

Nov 11, 2010

Last Update Posted:

Nov 19, 2013

Last Verified:

Nov 1, 2013

Keywords provided by , ,

Pediatric refractory or relapsed acute leukemia

Additional relevant MeSH terms:

Leukemia

Acute Disease

Irinotecan

Study Results

No Results Posted as of Nov 19, 2013