Overview

Tandem High Dose Chemotherapy and Autologous Stem Cell Rescue for High Risk Pediatric Brain Tumors

Status:
Unknown status
Trial end date:
2014-02-01
Target enrollment:
0
Participant gender:
All
Summary
The investigators plan to improve event free survival rate and reduce treatment related toxicities of pediatric patients with high risk/recurrent CNS tumors by administrating tandem high dose chemotherapy and autologous stem cell rescue.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Seoul National University Hospital
Treatments:
Carboplatin
Etoposide
Etoposide phosphate
Melphalan
Thiotepa
Topotecan
Criteria
Inclusion Criteria:

1. High risk pediatric brain tumors Newly diagnosed medulloblastoma, CNS PNET, ATRT,
Choroid plexus carcinoma, pineoblastoma with residual tumor over 1.5cm2 after
operation or with leptomeningeal seeding at diagnosis

2. All high grade or malignant brain tumor, age < 3 years

3. Recurrent embryonal brain tumors, recurrent CNS germ cell tumor

4. Age : no limitation

5. Performance status : ECOG 0-2.

6. 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 ⅹ upper limit of
normal; ALT < 3 ⅹ upper limit of normal. Kidney: creatinine < 2 ⅹ normal or a
creatinine clearance (GFR) > 60 ml/min/1.73m2.

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

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

Exclusion Criteria:

1. Patients who do not reach partial response prior to high dose chemotherapy.

2. Pregnant or nursing women.

3. Malignant (except brain tumor) or nonmalignant illness that is uncontrolled or whose
control may be jeopardized by complications of study therapy.

4. Psychiatric disorder that would preclude compliance.

5. Patients who, in the opinion of the investigator, may not be able to comply with the
safety monitoring requirements of the study.