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

NCT ID: NCT01342237

Last Updated: 2013-11-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-03-31

Study Completion Date

2014-02-28

Brief Summary

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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.

Detailed Description

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High risk/recurrent central nervous system (CNS) tumors have a poor prognosis so that tandem high dose chemotherapy (HDCT) with hematopoietic progenitor stem cell rescues has been chosen as potentially curative therapy. Many institutions have used carboplatin, thiotepa, etoposide (CTE) for conditioning regimen of 1st HDCT and cyclophosphamide, melphalan (CM) for conditioning regimen of 2nd HDCT. Our institution applied this regimen to the 38 pediatric patients with high risk brain tumor since 1996. Although the 3 year overall survival rate and event free survival rate were improved to 69% and 47.9%, respectively, the results showed relatively high treatment related mortality (TRM) rate of 21%. Toxicity of this tandem regimen was also reported as being high up to 32% in other researches as well so that this regimen is considered not feasible due to toxicity. In this study, 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 with topotecan, thiotepa, carboplatin (TTC) for 1st HDCT and melphalan, etoposide, carboplatin (MEC) for 2nd HDCT.

Conditions

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Brain Tumors

Keywords

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Brain tumors Stem cell transplantation topotecan thiotepa carboplatin melphalan etoposide

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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topotecan

Group Type EXPERIMENTAL

HDCT 1(TTC), HDCT2(MEC)

Intervention Type DRUG

1. TTC Topotecan (2 mg/m2 once daily i.v. on days -8, -7, -6, -5, -4) Thiotepa (300 mg/m2 once daily i.v on days -8, -7, -6) Carboplatin (500 mg/m2 once daily i.v on days -5, -4, -3) (max. 700 mg/day)
2. MEC Melphalan (140 mg/m2 once daily i.v on day -7, 70 mg/m2 once daily i.v on day -6) Etoposide (200 mg/m2 once daily i.v on days -8, -6) Carboplatin (350 mg/m2 once daily i.v on days -8, -7, -6, -5)

Interventions

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HDCT 1(TTC), HDCT2(MEC)

1. TTC Topotecan (2 mg/m2 once daily i.v. on days -8, -7, -6, -5, -4) Thiotepa (300 mg/m2 once daily i.v on days -8, -7, -6) Carboplatin (500 mg/m2 once daily i.v on days -5, -4, -3) (max. 700 mg/day)
2. MEC Melphalan (140 mg/m2 once daily i.v on day -7, 70 mg/m2 once daily i.v on day -6) Etoposide (200 mg/m2 once daily i.v on days -8, -6) Carboplatin (350 mg/m2 once daily i.v on days -8, -7, -6, -5)

Intervention Type DRUG

Other Intervention Names

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Topotecan Thiotepa Carboplatin Melphalan Etoposide

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Seoul National University Hospital

Principal Investigators

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Hyoung Jin Kang, M.D., Ph.D

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Locations

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Seoul National University Hospital

Seoul, Daehangno, Jongno-gu, South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Hyoung Jin Kang, MD, PhD

Role: CONTACT

Phone: 82 2 2072 3304

Email: [email protected]

Hyery Kim, MD

Role: CONTACT

Phone: 82 2 2072 0177

Email: [email protected]

Facility Contacts

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Hyoung Jin Kang, MD, ph.D

Role: primary

Hyery Kim, MD

Role: backup

Other Identifiers

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SNUCH-SCT-1102

Identifier Type: -

Identifier Source: org_study_id