Newly Diagnosed High Risk NeuroblastomaPhase 2NCT02771743
Response-based Treatment of High-risk Neuroblastoma
A Phase 2 study testing Cisplatin, Doxorubicin and Etoposide in people with Newly Diagnosed High Risk Neuroblastoma, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
The purpose of this study is to improve outcome of high risk neuroblastoma by tailoring the treatment intensity of tandem high dose chemotherapy according to the treatment response to induction chemotherapy. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Newly Diagnosed High Risk Neuroblastoma
- What is being tested?
- Cisplatin, Doxorubicin and Etoposide
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteSouth Korea
- Study dates
- Apr 2015to Mar 2023
- 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
- Patients with newly diagnosed high risk neuroblastoma
- Patients with informed consent
Who cannot join
- Patients with progressive disease or relapse
- Patients who underwent high dose chemotherapy before
- Patients with organ dysfunction as follows (creatinine elevation > 3 x upper limit of normal, Total bilirubin > 3 x upper limit of normal, aspartate transaminase/alanine transaminase > 5 x upper limit of normal), ejection fraction <40%
- Pregnant or nursing women
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Samsung Medical Center
Seoul
Ki Woong Sung, 82-2-3410-3529, kwsped@skku.edu
Ki Woong Sung
About this study
The purpose of this study is to improve outcome of high risk neuroblastoma by tailoring the treatment intensity of tandem high dose chemotherapy according to the treatment response to induction chemotherapy.
Read the detailed description
Although the outcome of high-risk neuroblastoma improved after the introduction of high-dose chemotherapy and autologous stem cell transplantation (HDCT/autoSCT), the outcome still needs to be unsatisfactory.
In the investigator's previous study, good responders who had greater reduction of tumor volume after induction chemotherapy showed lower relapse-free survival compared to poor responders.Simultaneously, the reduction in tumor volume also was greater in patients who died of treatment related mortality than patients who had relapsed tumors. These findings suggest that tailoring treatment intensity according to the early tumor response to induction chemotherapy may improve patient outcomes. So, in this study investigators tailored the treatment intensity of high dose chemotherapy according to the treatment response to induction chemotherapy.
- Conditions
- Newly Diagnosed High Risk Neuroblastoma
- Being tested
- Cisplatin, Doxorubicin, Etoposide, Cyclophosphamide, Ifosfamide
- Keywords
- Neuroblastoma, High risk, Tandem high dose chemotherapy
- Medical subject headings
- Neuroblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CisplatinDrug
DoxorubicinDrug
EtoposideDrug
CyclophosphamideDrug
IfosfamideDrug
CarboplatinDrug
Tandem HDCT/auto-SCTProcedure or surgery
RadiotherapyRadiation
Interleukin-2Drug
IsotretinoinDrug
MIBGRadiation
| Study group | Role | What they receive |
|---|---|---|
| High risk neuroblastoma | Experimental | 1. Nine cycles of induction chemotherapy with cisplatin, etoposide, doxorubicin, cyclophosphamide (CEDC) and ifosfamide, carboplatin, etoposide (ICE) regimen
2. Upfront surgery or surgery after 6 cycles of chemotherapy
3. Peripheral stem cell mobilization after 7 cycles of chemotherapy
4. Tandem high dose chemotherapy with autologous stem cell transplantation (Tandem HDCT/auto-SCT)
* Dose of chemotherapeutic agents of 1st HDCT is tailored according to the residual positron emission tomography (PET)/Metaiodobenzylguanidine (MIBG) uptake before 1st HDCT
* Dose of MIBG of 2nd HDCT is tailored according to the residual PET/MIBG uptake before 2nd HDCT
5. Radiotherapy after tandem HDCT
6. Immunotherapy and differentiation therapy with Interleukin-2/isotretinoin Receives: Drug: Cisplatin; Drug: Doxorubicin; Drug: Etoposide; Drug: Cyclophosphamide; Drug: Ifosfamide; Drug: Carboplatin; Procedure: Tandem HDCT/auto-SCT; Radiation: Radiotherapy; Drug: Interleukin-2; Drug: Isotretinoin; Radiation: MIBG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of event free survival
Measured: Up to 3 years
Secondary outcomes (1)
Rate of late adverse effects
Measured: Up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2016 (estimated)
- Study startApr 2015
- Primary completionMar 2020 (estimated)
- Study completionMar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Newly Diagnosed High Risk NeuroblastomaStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ki Woong Sung, MD, PhD, Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02771743
- Sponsor's protocol ID
- 2015-02-064
- Status last verified
- May 2016
- First submitted
- 12 May 2016
- Last updated
- 24 May 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Response-based Treatment of High-risk Neuroblastoma
- ClinicalTrials.gov ID
- NCT02771743
- Acronym / sponsor ID
- 2015-02-064
- Conditions
- Newly Diagnosed High Risk Neuroblastoma
- Keywords
- Neuroblastoma, High risk, Tandem high dose chemotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- Mar 2020 (estimated)
- Study completion
- Mar 2023 (estimated)
- First posted
- 13 May 2016 (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.
The purpose of this study is to improve outcome of high risk neuroblastoma by tailoring the treatment intensity of tandem high dose chemotherapy according to the treatment response to induction chemotherapy.
Detailed description
Although the outcome of high-risk neuroblastoma improved after the introduction of high-dose chemotherapy and autologous stem cell transplantation (HDCT/autoSCT), the outcome still needs to be unsatisfactory.
In the investigator's previous study, good responders who had greater reduction of tumor volume after induction chemotherapy showed lower relapse-free survival compared to poor responders.Simultaneously, the reduction in tumor volume also was greater in patients who died of treatment related mortality than patients who had relapsed tumors. These findings suggest that tailoring treatment intensity according to the early tumor response to induction chemotherapy may improve patient outcomes. So, in this study investigators tailored the treatment intensity of high dose chemotherapy according to the treatment response to induction chemotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| High risk neuroblastoma | Experimental | Drug: Cisplatin, Drug: Doxorubicin, Drug: Etoposide, Drug: Cyclophosphamide, Drug: Ifosfamide, Drug: Carboplatin, Procedure: Tandem HDCT/auto-SCT, Radiation: Radiotherapy, Drug: Interleukin-2, Drug: Isotretinoin, Radiation: MIBG1. Nine cycles of induction chemotherapy with cisplatin, etoposide, doxorubicin, cyclophosphamide (CEDC) and ifosfamide, carboplatin, etoposide (ICE) regimen 2. Upfront surgery or surgery after 6 cycles of chemotherapy 3. Peripheral stem cell mobilization after 7 cycles of chemotherapy 4. Tandem high dose chemotherapy with autologous stem cell transplantation (Tandem HDCT/auto-SCT) * Dose of chemotherapeutic agents of 1st HDCT is tailored according to the residual positron emission tomography (PET)/Metaiodobenzylguanidine (MIBG) uptake before 1st HDCT * Dose of MIBG of 2nd HDCT is tailored according to the residual PET/MIBG uptake before 2nd HDCT 5. Radiotherapy after tandem HDCT 6. Immunotherapy and differentiation therapy with Interleukin-2/isotretinoin |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with newly diagnosed high risk neuroblastoma
- Patients with informed consent
Key exclusion criteria (4 listed)
- Patients with progressive disease or relapse
- Patients who underwent high dose chemotherapy before
- Patients with organ dysfunction as follows (creatinine elevation > 3 x upper limit of normal, Total bilirubin > 3 x upper limit of normal, aspartate transaminase/alanine transaminase > 5 x upper limit of normal), ejection fraction <40%
- Pregnant or nursing women
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 |
|---|---|---|
| Cisplatin | Drug | High risk neuroblastoma |
| Doxorubicin | Drug | High risk neuroblastoma |
| Etoposide | Drug | High risk neuroblastoma |
| Cyclophosphamide | Drug | High risk neuroblastoma |
| Ifosfamide | Drug | High risk neuroblastoma |
| Carboplatin | Drug | High risk neuroblastoma |
| Tandem HDCT/auto-SCT | Procedure or surgery | High risk neuroblastoma |
| Radiotherapy | Radiation | High risk neuroblastoma |
| Interleukin-2 | Drug | High risk neuroblastoma |
| Isotretinoin | Drug | High risk neuroblastoma |
| MIBG | Radiation | High risk neuroblastoma |
Primary outcome
Rate of event free survival
Time frame: Up to 3 years
1 secondary outcome
Rate of late adverse effects
Time frame: Up to 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2016.
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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, MD, PhD 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 Cisplatin, Doxorubicin and Etoposide in people with Newly Diagnosed High Risk Neuroblastoma, 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 2 inclusion and 4 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 24 May 2016. 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?
Contact Ki Woong Sung, MD, PhD (82-2-3410-3529, kiwoong.sung@samsung.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of event free survival (time frame: Up to 3 years). 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 24 May 2016.