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Trial Title:
Irinotecan Combination Chemotherapy for Refractory or Relapsed Brain Tumor in Children and Adolescents
NCT ID:
NCT01535183
Condition:
Brain Tumor
Conditions: Official terms:
Brain Neoplasms
Irinotecan
Conditions: Keywords:
irinotecan
brain tumor
pediatrics
salvage therapy
chemotherapy
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Unknown status
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Irinotecan combination chemotherapy
Description:
Irrinotecan 300㎎/㎡ d0 IVS mixed with D5W 500mL over 90min with atropine (-30 min)
VCR 2㎎/㎡ d0 IV push
Etoposide 100㎎/㎡ d0-d2 IV over 1hr
Carboplatin 450㎎/㎡ d0 IV over 8hrs
Cyclophosphamide 1,000㎎/㎡ d1 IVS with mesna
Arm group label:
Irinotecan
Other name:
Camptosar (Pfizer) or Campto (Yakult Honsha)
Summary:
The outcome of pediatric refractory or relapsed brain tumor is very dismal. Standard
chemotherapy showed poor response to these patients. Although tandem high dose
chemotherapy with hematopoietic progenitor stem cell rescues has been chosen as a
potentially curative therapy for long term survival and better outcome is expected if
tumor burden before transplantation reduced by chemotherapy, effective salvage
chemotherapy for tumor reduction is not established yet. Irinotecan is a recently
developed topoisomerase I inhibitor, and there are preclinical and phase I, II data which
proved practical effects in brain tumors. In those studies, irinotecan was administered
alone or in combination with one other drug.
Vincristine, etoposide, carboplatin, and cyclophosphamide have been used in many
protocols for brain tumors but the result was very poor in refractory or relapsed cases.
However, irinotecan can be effective with these multiple chemotherapeutic agents.
According to the pilot study of irinotecan in combination with vincristine, etoposide,
carboplatin and cyclophosphamide in the investigators center, 75% percent of total 12
patients reached more than stable disease, and 2 patients got long term complete
remission only with this multi-agent combination chemotherapy. But the combination of
irinotecan, vincristine, etoposide, carboplatin, and cyclophosphamide is not clinically
studied yet especially for pediatric patients. To improve response rate and
progression-free survival, the combination chemotherapy of irinotecan, vincristine,
etoposide, carboplatin, and cyclophosphamide is designed for pediatric refractory or
relapsed brain tumor.
Criteria for eligibility:
Criteria:
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
normal.
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.
Gender:
All
Minimum age:
N/A
Maximum age:
19 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Seoul National University Hospital
Address:
City:
Seoul
Zip:
110-744
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Hyoung Jin Kang, M.D., Ph.D
Phone:
82-2-2072-3304
Email:
kanghj@snu.ac.kr
Contact backup:
Last name:
Hyery Kim, M.D.
Phone:
82-2-2072-3452
Email:
taban@hanmail.net
Start date:
January 2012
Completion date:
December 2016
Lead sponsor:
Agency:
Seoul National University Hospital
Agency class:
Other
Source:
Seoul National University Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT01535183
