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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2009 by Samsung Medical Center.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
KSPNO stem cell transpantation committee
Information provided by:
Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT00798811
First received: November 25, 2008
Last updated: October 11, 2009
Last verified: October 2009
History of Changes
  Purpose
  • 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

Condition Intervention Phase
Brain Tumor
 Procedure: high-dose chemotherapy and autologous stem cell rescue
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Multicenter Clinical Trial to Evaluate Efficacy of High-dose Chemotherapy With Autologous Stem Cell Rescue for Children With High-risk Brain Tumors

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Samsung Medical Center:

Primary Outcome Measures:
  • overall survival, event-free survival [ Time Frame: one year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • toxicity [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 100
Study Start Date: September 2008
Estimated Study Completion Date: August 2012
Estimated Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
 Procedure: high-dose chemotherapy and autologous stem cell rescue
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-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
 Procedure: high-dose chemotherapy and autologous stem cell rescue
Surgery pre-HDCT chemotherapy (6 cycles: A1, B1, A2, B2, A3, B3) PBSC collection during first cycle of chemotherapy (A1) (2nd look surgery if necessary) (if relapse or progression prior to HDCT, off study -> enroll S-083 protocol) HDCT1 (CTE) HDCT2 (CM) (RT if necessary) Observe
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
 Procedure: high-dose chemotherapy and autologous stem cell rescue
(Surgery if possible) Chemotherapy (4 cycles) PBSC collection during first cycle of chemotherapy during 4th cycle of chemotherapy (if BM involvement) (RT, if possible, after PBSC collection) (if less than PR prior to HDCT, off study) HDCT1 (CTE) HDCT2 (CM)

Detailed Description:

Although significant progress has been made in the treatment of brain tumors, the prognosis remains dismal in patients with relapsed tumor. The outlook for infants and young children is also poor, primarily because of the limited use of radiotherapy, although a recent report suggested that vigorous combination chemotherapy alone improved the survival of young children without macroscopic metastases at diagnosis. The prognosis is also not satisfactory when a large residual tumor remains after surgery or when leptomeningeal seeding is present at diagnosis. Given the above situation, we plan to explore the possible efficacy of high-dose chemotherapy and autologous stem cell rescue in patients with high-risk embryonal tumors, relapsed brain tumors and in infants and young children with brain tumors.High-dose chemotherapy and autologous stem cell rescue has improved the survival of children with high-risk solid tumors. this treatment strategy is based on the hypothesis that a dose escalation might improve the survival of children with high-risk solid tumors.Many investigators demonstrated that further dose escalation using sequential high-dose chemotherapy and autologous stem cell rescue might result in additional improvements in the survival of patients with high-risk tumors. As embryonal brain tumors are a chemosensitive tumors, a strategy using high-dose chemotherapy might be effective in the treatment of high-risk embryonal brain tumors and relapsed brain tumors. In addition, it might defer or eliminate irradiation in infants and young children with brain tumors

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00798811

Contacts
Contact: Ki Woong Sung 82-2-3410-3529 kwsped@skku.edu

Locations
Korea, Republic of
Samsung Medical Center Recruiting
Seoul, Korea, Republic of
Contact: Ki Woong Sung     82-2-3410-3529     kwsped@skku.edu    
Principal Investigator: Ki Woong Sung            
Sponsors and Collaborators
Samsung Medical Center
KSPNO stem cell transpantation committee
Investigators
Principal Investigator: Ki Woong Sung Samsung Medical Center
  More Information

No publications provided

Responsible Party: Ki Woong Sung, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT00798811     History of Changes
Other Study ID Numbers: 2005-12-009
Study First Received: November 25, 2008
Last Updated: October 11, 2009
Health Authority: Korea: Institutional Review Board

Keywords provided by Samsung Medical Center:
brain tumor
high-dose chemotherapy
autologous stem cell transplantation
infant

Additional relevant MeSH terms:
Brain Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
 Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on May 16, 2013