High-dose Chemotherapy With Autologous Stem Cell Rescue in Pediatric High-risk Brain Tumors
March 18, 2020 updated by: Samsung Medical Center
Multicenter Clinical Trial to Evaluate Efficacy of High-dose Chemotherapy With Autologous Stem Cell Rescue for Children With High-risk Brain Tumors
- 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
Study Overview
Status
Unknown
Conditions
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
Study Type
Interventional
Enrollment (Anticipated)
100
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Seoul, Korea, Republic of
- Samsung Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: 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
|
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)
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
(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)
|
|
Other: 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
|
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)
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
(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)
|
|
Other: 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
|
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)
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
(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)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
overall survival, event-free survival
Time Frame: one year
|
one year
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
toxicity
Time Frame: 5 years
|
5 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2005
Primary Completion (Actual)
December 1, 2019
Study Completion (Anticipated)
December 1, 2021
Study Registration Dates
First Submitted
November 25, 2008
First Submitted That Met QC Criteria
November 25, 2008
First Posted (Estimate)
November 26, 2008
Study Record Updates
Last Update Posted (Actual)
March 19, 2020
Last Update Submitted That Met QC Criteria
March 18, 2020
Last Verified
March 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2005-12-009
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