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

NCT01239485 | Unknown Phase 1 DMC

• 1 other identifier: SCLSG-0901, SNUCH-RAL-0901
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Leukemia

Keywords

Pediatric refractory or relapsed acute leukemia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (1)

Irinotecan

EXPERIMENTAL

Drug: Irinotecan

Interventions

Irinotecan DRUG

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.

Irinotecan

Eligibility Criteria

• Age: Up to 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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%

You may not qualify if:

• 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.

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, Chongno-gu, 110-744, South Korea

RECRUITING

MeSH Terms

Interventions

Irinotecan

Intervention Hierarchy (Ancestors)

Camptothecin; Alkaloids; Heterocyclic Compounds

Study Officials

• Hyoung Jin Kang, M.D, ph.D

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hyoung Jin Kang, M.D, Ph.D

CONTACT

82 2 2072 3304; kanghj@snu.ac.kr

Ji Won Lee, M.D

CONTACT

82 2 2072 0177; agnesjw@hanmail.net

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 8, 2010
• First Posted: November 11, 2010
• Study Start: November 1, 2010
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: November 19, 2013

Record last verified: 2013-11

Locations

KR (1)