High-dose Chemotherapy With Autologous Stem Cell Rescue in Pediatric High-risk Brain Tumors
Conditions
Brain Tumor
Conditions: official terms
Brain Neoplasms
Conditions: Keywords
brain tumor, high-dose chemotherapy, autologous stem cell transplantation, infant
Study Type
Interventional
Study Phase
Phase 2
Study Design
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: high-dose chemotherapy and autologous stem cell rescue Type: Procedure
Name: high-dose chemotherapy and autologous stem cell rescue Type: Procedure
Name: high-dose chemotherapy and autologous stem cell rescue Type: Procedure
Overall Status
Recruiting
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
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
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: N/A
Gender: Both
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
Location
Samsung Medical Center
Seoul, Korea, Republic of
Status: Recruiting
Contact: Ki Woong Sung - 82-2-3410-3529 - kwsped@skku.edu
Start Date
September 2008
Completion Date
August 2012
Sponsors
Samsung Medical Center
Source
Samsung Medical Center
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page