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Irinotecan, Vincristine, Etoposide, Carboplatin, and Cyclophosphamide for Refractory or Relapsed Brain Tumor in Children and Adolescents

Phase 2
19 Years
Open (Enrolling)
Brain Tumor

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Trial Information

Irinotecan, Vincristine, Etoposide, Carboplatin, and Cyclophosphamide for Refractory or Relapsed Brain Tumor in Children and Adolescents

Inclusion Criteria:

- Diagnosis of brain tumor : embryonal brain tumor (medulloblastoma, CNS PNET, ATRT,
etc), intracranial germ cell tumor

- Relapse or refractory state

- Prior therapy : Patients must have fully recovered from the acute toxic effects of
all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study.
Patients are eligible 8 weeks from the day of stem cell infusion for autologous stem
cell transplant, if hematological and all other eligibility criteria are met.

- 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

3. Kidney: creatinine <2 × normal

- Patients must lack any active viral infections or active fungal infection.

- Patients (or one of parents if patients age < 20) should sign informed consent.

Exclusion Criteria:

- Pregnant or nursing women.

- Malignant (except brain tumor) 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.

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To evaluate response rate (more than stable disease) of combination chemotherapy

Outcome Description:

- Response Criteria : WHO-based "Macdonald criteria", based on MRI Complete Response : disappearance of all enhancing tumor Partial Remission : more than 50 percentage decrease in the tumor measurement compared with the baseline scan Stable Disease : includes changes that do not meet criteria for CR, PR, or progressive disease (PD) Progressive Disease : more than 25 percentage increase in tumor measurement compared with the lesion size that defines the nadir, or smallest measurement, in the serial studies

Outcome Time Frame:

every 3 months

Safety Issue:


Principal Investigator

Hyoung Jin Kang, M.D., ph.D

Investigator Role:

Principal Investigator

Investigator Affiliation:

Seoul National University Hospital


Korea: Food and Drug Administration

Study ID:




Start Date:

January 2012

Completion Date:

December 2016

Related Keywords:

  • Brain Tumor
  • irinotecan
  • brain tumor
  • pediatrics
  • salvage therapy
  • chemotherapy
  • Brain Neoplasms