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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2013 by Seoul National University Hospital.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01239485
First Posted: November 11, 2010
Last Update Posted: November 19, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Seoul National University Hospital
  Purpose
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 Intervention Phase
Acute Leukemia Drug: Irinotecan Phase 1

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Seoul National University Hospital:

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. [ Time Frame: 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. [ Time Frame: 2 years ]

Estimated Enrollment: 18
Study Start Date: November 2010
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.


  Eligibility

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Ages Eligible for Study:   up to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
    • 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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01239485


Contacts
Contact: Hyoung Jin Kang, M.D, Ph.D 82 2 2072 3304 kanghj@snu.ac.kr
Contact: Ji Won Lee, M.D 82 2 2072 0177 agnesjw@hanmail.net

Locations
Korea, Republic of
Seoul National University Hospital Recruiting
Seoul, Chongno-gu, Korea, Republic of, 110-744
Contact: Hyoung Jin Kang, M.D, Ph.D    82 2 2072 3304    kanghj@snu.ac.kr   
Sponsors and Collaborators
Seoul National University Hospital
Investigators
Principal Investigator: Hyoung Jin Kang, M.D, ph.D Seoul National University Hospital
  More Information

Responsible Party: Korea Childhood Leukemia Foundation
ClinicalTrials.gov Identifier: NCT01239485     History of Changes
Other Study ID Numbers: SCLSG-0901, SNUCH-RAL-0901
First Submitted: November 8, 2010
First Posted: November 11, 2010
Last Update Posted: November 19, 2013
Last Verified: November 2013

Keywords provided by Seoul National University Hospital:
Pediatric refractory or relapsed acute leukemia

Additional relevant MeSH terms:
Leukemia
Acute Disease
Neoplasms by Histologic Type
Neoplasms
Disease Attributes
Pathologic Processes
Irinotecan
Camptothecin
Etoposide
Etoposide phosphate
Cytarabine
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Topoisomerase II Inhibitors
Antimetabolites, Antineoplastic
Antimetabolites
Antiviral Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs