High-dose Chemotherapy With Autologous Stem Cell Rescue in Pediatric High-risk Brain Tumors

NCT00798811 | Unknown Phase 2 DMC

• 1 other identifier: 2005-12-009
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

• Study No.: KSPNO-S-081 Reduced-dose Craniospinal Radiotherapy Followed by High-dose Chemotherapy and Autologous Stem Cell Rescue in Children with Newly Diagnosed High-risk Brain Tumor
• Study No.: KSPNO-S-082 High-dose Chemotherapy and Autologous Stem Cell Rescue in Infants and Young Children with Newly Diagnosed High-risk Brain Tumor To Avoid or Reduce Craniospinal Radiation
• Study No.: KSPNO-S-083 High-dose Chemotherapy and Autologous Stem Cell Rescue in Children with Recurrent Brain Tumor or Non-germinomatous Germ Cell Tumor with Inadequate Response to Conventional Treatment

Conditions

Brain Tumor

Keywords

brain tumor; high-dose chemotherapy; autologous stem cell transplantation; infant

Outcome Measures

Primary Outcomes (1)

• overall survival, event-free survival

  one year

Secondary Outcomes (1)

• toxicity

  5 years

Study Arms (3)

KSPNO-S-081

OTHER

Reduced-dose Craniospinal Radiotherapy Followed by High-dose Chemotherapy and Autologous Stem Cell Rescue in Children with Newly Diagnosed High-risk Brain Tumor

Procedure: high-dose chemotherapy and autologous stem cell rescue

KSPNO-S-082

OTHER

High-dose Chemotherapy and Autologous Stem Cell Rescue in Infants and Young Children with Newly Diagnosed High-risk Brain Tumor To Avoid or Reduce Craniospinal Radiation

Procedure: high-dose chemotherapy and autologous stem cell rescue

KSPNO-S-083

OTHER

High-dose Chemotherapy and Autologous Stem Cell Rescue in Children with Recurrent Brain Tumor or Non-germinomatous Germ Cell Tumor with Inadequate Response to Conventional Treatment

Procedure: high-dose chemotherapy and autologous stem cell rescue

Interventions

high-dose chemotherapy and autologous stem cell rescue PROCEDURE

Surgery -\> enroll Pre-RT chemotherapy (2 cycles: A1, B1) PBSC collection during first cycle (A1) (2nd look surgery if necessary) RT (Reduced dose CSI) Post-RT chemotherapy (4 cycles: A2, B2, A3, B3) (if relapse or progression prior to HDCT, off study -\> enroll S-083 protocol) HDCT1 (CTE) HDCT2 (CM)

KSPNO-S-081

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• KSPNO-S-081: newly diagnosed embryonal brain tumor, age \>= 3 years
• KSPNO-S-082: all high-grade or malignant brain tumor, age \<3 years
• KSPNO-S-083: recurrent embryonal brain tumors, recurrent CNS germ cell tumor

You may not qualify if:

• Patients with severe comorbid organ dysfunction (NCI grade \> 2 organ toxicity) prior to high-dose chemotherapy
• Patients with progressed tumor prior to high-dose chemotherapy
• Patients whose parents do not want to undergo high-dose chemotherapy and autologous stem cell rescue

Sponsors & Collaborators

• Samsung Medical Center: lead
• KSPNO stem cell transpantation committee: collaborator

Study Sites (1)

Samsung Medical Center

Seoul, South Korea

Location

MeSH Terms

Conditions

Brain Neoplasms

Interventions

Drug Therapy

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Ki Woong Sung

  Samsung Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 25, 2008
• First Posted: November 26, 2008
• Study Start: September 1, 2005
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2021
• Last Updated: March 19, 2020

Record last verified: 2020-03

Locations

KR (1)