Trial · NCT01334515
Biological Therapy, Sargramostim, and Isotretinoin in Treating Patients With Relapsed or Refractory Neuroblastoma
NCT01334515, Phase 2, Completed, Children's Oncology Group; results first posted 2015-02-20
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Biological Therapy, Sargramostim, and Isotretinoin in Treating Patients With Relapsed or Refractory Neuroblastoma. Trials, record NCT01334515. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01334515
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Biological Therapy, Sargramostim, and Isotretinoin in Treating Patients With Relapsed or Refractory Neuroblastoma
- NCT number
- NCT01334515
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 52 participants, actual
- Lead sponsor
- Children's Oncology Group
- Conditions
- Recurrent Neuroblastoma
- Interventions
- hu14.18-IL2 fusion protein, isotretinoin, sargramostim, laboratory biomarker analysis
- First posted
- 2011-04-13
- Last updated
- 2019-10-21
- Results first posted
- 2015-02-20
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Patients With Unacceptable Dose Limiting Toxicities (DLTs) | Up to 10 courses | Test for tolerability and monitor for the occurrence of too many unacceptable DLTs using a two-stage stopping rule: (Stage 1) Accrue 10 patients. If more than 1 experience at least one unacceptable DLT during the first treatment cycle, the regimen will be considered to have unacceptable toxicity, and accrual will be temporarily closed, to review all relevant data and consider modifying the regimen to improve safety. If 1 or no patients have an unacceptable DLT in the first treatment cycle, then continue. (Stage 2) Accrue 20 more patients. If 7 or more experience at least one unacceptable DLT in the first treatment cycle, temporarily close the study for possible dosing-safety modifications. If 6 or fewer have an unacceptable DLT in the first treatment cycle, it is reasonable to assume that the combination therapy is safe. |
| Secondary | Overall Response Evaluated in This Study Using the New International Criteria Proposed by the Revised Response Evaluation Criteria in Solid Tumors (RECIST) | Every two cycles (each cycle lasts 28 days) | Number of patients where best overall response is a complete response (CR)-\[disappearance of all target lesions and disappearance of any other measureable disease\], a very Good Partial Response (VGPR)- \[\>90% decrease of the disease measurement for CT/MRI lesions, taking as reference the disease measurement done to confirm measurable disease at study entry. Non-target CT/MRI lesions stable to smaller in size\], or partial Response (PR)- \[\>= 30% decrease in the disease measurement, taking as reference the disease measurement done to confirm measurable disease at study entry. Non-target CT/MRI lesions stable to smaller in size\], and maintains the response. It is possible that a subject's response to therapy may not occur until after several months of treatment. In order to prevent bias, the maximum duration of time/treatment over which a subject's response is to be assessed for determination of the best overall response is after the completion of up to 10 courses. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Patients With Unacceptable Dose Limiting Toxicities (DLTs) | Up to 10 courses | This outcome measure evaluates the first 30 patients to enroll and who receive at least one dose of hu14.18-IL2. | participants | NUMBER |
| SECONDARY | Overall Response Evaluated in This Study Using the New International Criteria Proposed by the Revised Response Evaluation Criteria in Solid Tumors (RECIST) | Every two cycles (each cycle lasts 28 days) | Patients will be evaluable for inclusion in the analysis of response if they have an event at any time on the study or if they complete at least 2 cycles of hu14.18-IL2 therapy. Patients who go off-protocol therapy prior to the completion of 2 cycles due to parent/family choice and/or due to toxicity will not be considered evaluable for response. | participants | NUMBER |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Patients With Unacceptable Dose Limiting Toxicities (DLTs) | Disease Measured by Standard Radiographic Criteria | Patients with Unacceptable DLTs | 1 | participants | |
| Number of Patients With Unacceptable Dose Limiting Toxicities (DLTs) | Disease Evaluable Only by I-MIBG or BM Histology | Patients with Unacceptable DLTs | 2 | participants | |
| Number of Patients With Unacceptable Dose Limiting Toxicities (DLTs) | Disease Measured by Standard Radiographic Criteria | Patients without Unacceptable DLTs | 9 | participants | |
| Number of Patients With Unacceptable Dose Limiting Toxicities (DLTs) | Disease Evaluable Only by I-MIBG or BM Histology | Patients without Unacceptable DLTs | 18 | participants | |
| Overall Response Evaluated in This Study Using the New International Criteria Proposed by the Revised Response Evaluation Criteria in Solid Tumors (RECIST) | Disease Measured by Standard Radiographic Criteria | Responders | 1 | participants | |
| Overall Response Evaluated in This Study Using the New International Criteria Proposed by the Revised Response Evaluation Criteria in Solid Tumors (RECIST) | Disease Evaluable Only by I-MIBG or BM Histology | Responders | 6 | participants | |
| Overall Response Evaluated in This Study Using the New International Criteria Proposed by the Revised Response Evaluation Criteria in Solid Tumors (RECIST) | Disease Measured by Standard Radiographic Criteria | Non-Responders | 14 | participants | |
| Overall Response Evaluated in This Study Using the New International Criteria Proposed by the Revised Response Evaluation Criteria in Solid Tumors (RECIST) | Disease Evaluable Only by I-MIBG or BM Histology | Non-Responders | 24 | participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Disease Measured by Standard Radiographic Criteria | 16 | |
| Overall Study | STARTED | Disease Evaluable Only by I-MIBG or BM Histology | 36 | |
| Overall Study | COMPLETED | Disease Measured by Standard Radiographic Criteria | 4 | |
| Overall Study | COMPLETED | Disease Evaluable Only by I-MIBG or BM Histology | 7 | |
| Overall Study | NOT COMPLETED | Disease Measured by Standard Radiographic Criteria | 12 | |
| Overall Study | NOT COMPLETED | Disease Evaluable Only by I-MIBG or BM Histology | 29 |
Source ClinicalTrials.gov
Adverse events186
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 | Anemia | Blood and lymphatic system disorders | Disease Measured by Standard Radiographic Criteria | 9 | 16 | 11 |
| other | Anemia | Blood and lymphatic system disorders | Disease Evaluable Only by I-MIBG or BM Histology | 11 | 36 | 11 |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Disease Measured by Standard Radiographic Criteria | 0 | 16 | 0 |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Disease Evaluable Only by I-MIBG or BM Histology | 1 | 36 | 1 |
| other | Cardiac disorders - Other | Cardiac disorders | Disease Measured by Standard Radiographic Criteria | 0 | 16 | 0 |
| other | Cardiac disorders - Other | Cardiac disorders | Disease Evaluable Only by I-MIBG or BM Histology | 1 | 36 | 1 |
| other | Mitral valve disease | Cardiac disorders | Disease Measured by Standard Radiographic Criteria | 0 | 16 | 0 |
| other | Mitral valve disease | Cardiac disorders | Disease Evaluable Only by I-MIBG or BM Histology | 1 | 36 | 1 |
| other | Hearing impaired | Ear and labyrinth disorders | Disease Measured by Standard Radiographic Criteria | 0 | 16 | 0 |
| other | Hearing impaired | Ear and labyrinth disorders | Disease Evaluable Only by I-MIBG or BM Histology | 3 | 36 | 3 |
1 to 10 of 186Source ClinicalTrials.gov
See all 186 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Disease Measured by Standard Radiographic Criteria | ||
| Total, all-cause mortality | Disease Evaluable Only by I-MIBG or BM Histology | ||
| Total, other adverse events | Disease Measured by Standard Radiographic Criteria | 13 | 16 |
| Total, other adverse events | Disease Evaluable Only by I-MIBG or BM Histology | 31 | 36 |
| Total, serious adverse events | Disease Measured by Standard Radiographic Criteria | 7 | 16 |
| Total, serious adverse events | Disease Evaluable Only by I-MIBG or BM Histology | 18 | 36 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
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 |
|---|---|---|---|---|---|
| U10CA098543 | Children's Oncology Group Chair's Grant | ADAMSON, PETER C. | CHILDREN'S HOSP OF PHILADELPHIA | NATIONAL CANCER INSTITUTE | 2003 to 2013 |
Source NIH RePORTER
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Disease Measured by Standard Radiographic Criteria vs Disease Evaluable Only by I-MIBG or BM Histology: serious adverse events |
Source Trial comparisons
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/NCT01334515
GET https://conductscience.org/api/trials/v1/NCT01334515/events?page=2