Trial · NCT01175356
Induction Therapy Including 131 I-MIBG and Chemotherapy in Treating Patients With Newly Diagnosed High-Risk Neuroblastoma Undergoing Stem Cell Transplant, Radiation Therapy, and Maintenance Therapy With Isotretinoin
NCT01175356, Phase 1, Completed, Children's Oncology Group; results first posted 2017-09-28
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Induction Therapy Including 131 I-MIBG and Chemotherapy in Treating Patients With Newly Diagnosed High-Risk Neuroblastoma Undergoing Stem Cell Transplant, Radiation Therapy, and Maintenance Therapy With Isotretinoin. Trials, record NCT01175356. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01175356
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
Induction Therapy Including 131 I-MIBG and Chemotherapy in Treating Patients With Newly Diagnosed High-Risk Neuroblastoma Undergoing Stem Cell Transplant, Radiation Therapy, and Maintenance Therapy With Isotretinoin
- NCT number
- NCT01175356
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 99 participants, actual
- Lead sponsor
- Children's Oncology Group
- Conditions
- Ganglioneuroblastoma, Localized Resectable Neuroblastoma, Localized Unresectable Neuroblastoma, Regional Neuroblastoma, Stage 4 Neuroblastoma, Stage 4S Neuroblastoma
- Interventions
3-Dimensional Conformal Radiation Therapy, Autologous Hematopoietic Stem Cell Transplantation, Busulfan, Cisplatin, Cyclophosphamide, Doxorubicin Hydrochloride, Etoposide Phosphate, External Beam Radiation Therapy, In Vitro-Treated Peripheral Blood Stem Cell Transplantation, Intensity-Modulated Radiation Therapy, Iobenguane I-131, Isotretinoin, Laboratory Biomarker Analysis, Melphalan, Pharmacological Study, Questionnaire Administration, Therapeutic Conventional Surgery, Topotecan Hydrochloride, Vincristine Sulfate
- First posted
- 2010-08-04
- Last updated
- 2026-01-23
- Results first posted
- 2017-09-28
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of MIBG Avid Patients Treated With Meta-iodobenxylguanide (MIBG) Labeled With Iodine-131 | Up to 6 weeks after course 5 of induction | Number of MIBG avid patients who receive 131I-MIBG divided by the number of patients evaluable for the feasibility of MIBG endpoint x 100%. |
| Primary | Percentage of MIBG Avid Patients Treated With MIBG Labeled With Iodine-131 and Bu/Mel Chemotherapy | Up to day -6 of conditioning | Number of MIBG avid patients who receive 131I-MIBG and Bu/Mel divided by the number of patients evaluable for the feasibility of MIBG and Bu/Mel consolidation endpoint x 100%. |
| Secondary | Incidence of Unacceptable Toxicity and Sinusoidal Obstruction Syndrome (SOS), Assessed by Common Terminology Criteria (CTV)v.4.0 for Toxicity Assessment and Grading for I-MIBG | Up to 6 weeks after course 5 of induction | Number of patients who had an unacceptable toxicity or experienced SOS. Unacceptable toxicity was defined as CTC Grade 4-5 Pulmonary/Respiratory. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of MIBG Avid Patients Treated With Meta-iodobenxylguanide (MIBG) Labeled With Iodine-131 | Up to 6 weeks after course 5 of induction | Includes patients who met criteria to receive 131I-MIBG but went off protocol therapy before receiving a dose assignment, but excludes patients that could not continue onto 131I-MIBG therapy due to lack of an open treatment slot. The definition of receiving MIBG labeled with iodine-131 is receiving 131I-MIBG. | Percentage of participants | NUMBER |
| PRIMARY | Percentage of MIBG Avid Patients Treated With MIBG Labeled With Iodine-131 and Bu/Mel Chemotherapy | Up to day -6 of conditioning | Includes patients who met criteria to receive 131I-MIBG but went off protocol therapy before receiving a dose assignment, but excludes patients that could not receive 131I-MIBG therapy due to lack of an open treatment slot. The definition of receiving Bu/Mel conditioning is receiving the first dose of planned Busulfan on Day -6 of conditioning. | Percentage of participants | NUMBER |
| SECONDARY | Incidence of Unacceptable Toxicity and Sinusoidal Obstruction Syndrome (SOS), Assessed by Common Terminology Criteria (CTV)v.4.0 for Toxicity Assessment and Grading for I-MIBG | Up to 6 weeks after course 5 of induction | Includes patients who received 131I-MIBG therapy. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group3
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of MIBG Avid Patients Treated With Meta-iodobenxylguanide (MIBG) Labeled With Iodine-131 | Treatment (131I-MIBG, Chemotherapy) | 86.8 | 95% Confidence Interval 76.7 to 92.9 | Percentage of participants | |
| Percentage of MIBG Avid Patients Treated With MIBG Labeled With Iodine-131 and Bu/Mel Chemotherapy | Treatment (131I-MIBG, Chemotherapy) | 82.2 | 95% Confidence Interval 68.7 to 90.7 | Percentage of participants | |
| Incidence of Unacceptable Toxicity and Sinusoidal Obstruction Syndrome (SOS), Assessed by Common Terminology Criteria (CTV)v.4.0 for Toxicity Assessment and Grading for I-MIBG | Treatment (131I-MIBG, Chemotherapy) | 3 | Participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Treatment (131I-MIBG, Chemotherapy) | 99 | |
| Overall Study | COMPLETED | Treatment (131I-MIBG, Chemotherapy) | 18 | |
| Overall Study | NOT COMPLETED | Treatment (131I-MIBG, Chemotherapy) | 81 |
Source ClinicalTrials.gov
Adverse events133
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | 13200-Anemia | Blood and lymphatic system disorders | Treatment (131I-MIBG, Chemotherapy) | 24 | 98 | 49 |
| other | 33300-Febrile neutropenia | Blood and lymphatic system disorders | Treatment (131I-MIBG, Chemotherapy) | 54 | 98 | 81 |
| other | 20000-Cardiac arrest | Cardiac disorders | Treatment (131I-MIBG, Chemotherapy) | 1 | 98 | 1 |
| other | 78900-Supraventricular tachycardia | Cardiac disorders | Treatment (131I-MIBG, Chemotherapy) | 1 | 98 | 1 |
| other | 38900-Hearing impaired | Ear and labyrinth disorders | Treatment (131I-MIBG, Chemotherapy) | 9 | 98 | 11 |
| other | 10100-Abdominal distension | Gastrointestinal disorders | Treatment (131I-MIBG, Chemotherapy) | 1 | 98 | 1 |
| other | 10300-Abdominal pain | Gastrointestinal disorders | Treatment (131I-MIBG, Chemotherapy) | 7 | 98 | 7 |
| other | 14900-Ascites | Gastrointestinal disorders | Treatment (131I-MIBG, Chemotherapy) | 5 | 98 | 5 |
| other | 22100-Colitis | Gastrointestinal disorders | Treatment (131I-MIBG, Chemotherapy) | 1 | 98 | 1 |
| other | 25700-Diarrhea | Gastrointestinal disorders | Treatment (131I-MIBG, Chemotherapy) | 6 | 98 | 7 |
1 to 10 of 133Source ClinicalTrials.gov
See all 133 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Treatment (131I-MIBG, Chemotherapy) | ||
| Total, other adverse events | Treatment (131I-MIBG, Chemotherapy) | 86 | 98 |
| Total, serious adverse events | Treatment (131I-MIBG, Chemotherapy) | 27 | 98 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 34028986 | DERIVED |
Source PubMed
Grants2
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|---|---|---|---|---|---|
| U10CA180886 | COG NCTN Network Group Operations Center | Hawkins, Douglas S. | COG RESEARCH FOUNDATION, LLC | NATIONAL CANCER INSTITUTE | 2014 to 2026 | NIH RePORTER |
| U10CA098543 | Children's Oncology Group Chair's Grant | ADAMSON, PETER C. | CHILDREN'S HOSP OF PHILADELPHIA | NATIONAL CANCER INSTITUTE | 2003 to 2013 | NIH RePORTER |
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01175356
GET https://conductscience.org/api/trials/v1/NCT01175356/events?page=2