Brain TumorPhase 2NCT00798811
High-dose Chemotherapy With Autologous Stem Cell Rescue in Pediatric High-risk Brain Tumors
A Phase 2 study testing high-dose chemotherapy and autologous stem cell rescue in people with Brain Tumor, run by Samsung Medical Center at 1 site in South Korea.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Brain Tumor
- What is being tested?
- high-dose chemotherapy and autologous stem cell rescue
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSouth Korea
- Study dates
- Sep 2005to Dec 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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
- Conditions
- Brain Tumor
- Being tested
- high-dose chemotherapy and autologous stem cell rescue
- Keywords
- brain tumor, high-dose chemotherapy, autologous stem cell transplantation, infant
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
high-dose chemotherapy and autologous stem cell rescueProcedure or surgery
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)
high-dose chemotherapy and autologous stem cell rescueProcedure or surgery
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
high-dose chemotherapy and autologous stem cell rescueProcedure or surgery
(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)
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 Receives: Procedure: high-dose chemotherapy and autologous stem cell rescue |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall survival, event-free survival
Measured: one year
Secondary outcomes (1)
toxicity
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2008 (estimated)
- Study startSep 2005
- Primary completionDec 2019
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain TumorStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- KSPNO stem cell transpantation committee
- Investigators
- Ki Woong Sung, Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00798811
- Sponsor's protocol ID
- 2005-12-009
- Status last verified
- Mar 2020
- First submitted
- 25 Nov 2008
- Last updated
- 19 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Clinical Trial to Evaluate Efficacy of High-dose Chemotherapy With Autologous Stem Cell Rescue for Children With High-risk Brain Tumors
- ClinicalTrials.gov ID
- NCT00798811
- Acronym / sponsor ID
- 2005-12-009
- Conditions
- Brain Tumor
- Keywords
- brain tumor, high-dose chemotherapy, autologous stem cell transplantation, infant
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Collaborators
- KSPNO stem cell transpantation committee
- Study start
- Sep 2005
- Primary completion
- Dec 2019 (actual)
- Study completion
- Dec 2021 (estimated)
- First posted
- 26 Nov 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| KSPNO-S-081 | Other | Procedure: high-dose chemotherapy and autologous stem cell rescueReduced-dose Craniospinal Radiotherapy Followed by High-dose Chemotherapy and Autologous Stem Cell Rescue in Children with Newly Diagnosed High-risk Brain Tumor |
| KSPNO-S-082 | Other | Procedure: high-dose chemotherapy and autologous stem cell rescueHigh-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 |
| KSPNO-S-083 | Other | Procedure: high-dose chemotherapy and autologous stem cell rescueHigh-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 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| high-dose chemotherapy and autologous stem cell rescueSurgery -> 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) | Procedure or surgery | KSPNO-S-081 |
| high-dose chemotherapy and autologous stem cell rescueSurgery 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 | Procedure or surgery | KSPNO-S-082 |
| 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) | Procedure or surgery | KSPNO-S-083 |
Primary outcome
overall survival, event-free survival
Time frame: one year
1 secondary outcome
toxicity
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ki Woong Sung principal investigator
Samsung Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing high-dose chemotherapy and autologous stem cell rescue in people with Brain Tumor, run by Samsung Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
overall survival, event-free survival (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2020.