NCT01342237

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
33

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Mar 2011

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 20, 2011

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 27, 2011

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
Last Updated

November 19, 2013

Status Verified

November 1, 2013

Enrollment Period

2.9 years

First QC Date

April 20, 2011

Last Update Submit

November 17, 2013

Conditions

Brain Tumors

Keywords

Brain tumorsStem cell transplantationtopotecanthiotepacarboplatinmelphalanetoposide

Outcome Measures

Primary Outcomes (1)

  • To evaluate event free survival rate

    To evaluate event free survival rate after high dose chemotherapy and autologous stem cell rescue in pediatric patients with high risk brain tumor

    1 month

Secondary Outcomes (3)

  • To evaluate treatment related mortality

    1, 3, 6, 12 month

  • To evaluate the incidence and severity of toxicity

    1, 3, 6, 12 month

  • To evaluate overall survival rate and relapse rate

    1, 3, 6, 12 month

Study Arms (1)

topotecan

EXPERIMENTAL
Drug: HDCT 1(TTC), HDCT2(MEC)

Interventions

HDCT 1(TTC), HDCT2(MEC)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)

Also known as: Topotecan, Thiotepa, Carboplatin, Melphalan, Etoposide
topotecan

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • All high grade or malignant brain tumor, age \< 3 years
  • Recurrent embryonal brain tumors, recurrent CNS germ cell tumor
  • Age : no limitation
  • 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.
  • 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.
  • Patients must lack any active viral infections or active fungal infection.
  • Patients (or one of parents if patients age \< 20) should sign informed.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, Daehangno, Jongno-gu, South Korea

RECRUITING

MeSH Terms

Conditions

Brain Neoplasms

Interventions

TopotecanThiotepaCarboplatinMelphalanEtoposide

Condition Hierarchy (Ancestors)

Central Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteNeoplasmsBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

CamptothecinAlkaloidsHeterocyclic CompoundsPhosphoramidesOrganophosphorus CompoundsOrganic ChemicalsTriethylenephosphoramideAziridinesAzirinesHeterocyclic Compounds, 1-RingCoordination ComplexesNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsPhenylalanineAmino Acids, AromaticAmino Acids, CyclicAmino AcidsAmino Acids, Peptides, and ProteinsPodophyllotoxinTetrahydronaphthalenesNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicPolycyclic CompoundsGlucosidesGlycosidesCarbohydrates

Study Officials

  • Hyoung Jin Kang, M.D., Ph.D

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hyoung Jin Kang, MD, PhD

CONTACT

82 2 2072 3304kanghj@snu.ac.kr

Hyery Kim, MD

CONTACT

82 2 2072 0177taban@hanmail.net

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 20, 2011

First Posted

April 27, 2011

Study Start

March 1, 2011

Primary Completion

February 1, 2014

Study Completion

February 1, 2014

Last Updated

November 19, 2013

Record last verified: 2013-11

Locations

KR(1)