Trial · NCT01857934
Therapy for Children With Advanced Stage Neuroblastoma
NCT01857934, Phase 2, Completed, St. Jude Children's Research Hospital; results first posted 2023-02-24
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Therapy for Children With Advanced Stage Neuroblastoma. Trials, record NCT01857934. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01857934
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Therapy for Children With Advanced Stage Neuroblastoma
- NCT number
- NCT01857934
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 153 participants, actual
- Lead sponsor
- St. Jude Children's Research Hospital
- Conditions
- Neuroblastoma
- Interventions
cyclophosphamide, topotecan, hu14.18K322A, peripheral blood stem cell harvest, surgical resection, cisplatin, etoposide, doxorubicin, vincristine, busulfan, melphalan, peripheral blood stem cell transplantation, natural killer cell infusion, radiation therapy, GM-CSF, G-CSF, mesna, levetiracetam, interleukin-2, Isotretinoin, CliniMACS
- First posted
- 2013-05-20
- Last updated
- 2026-09-22
- Results first posted
- 2023-02-24
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Response Rate [Complete Response + Very Good Partial Response + Partial Response (CR + VGPR + PR)] | After two initial courses of chemotherapy (approximately 6 weeks after enrollment) | Per the 1993 INRC: measurable tumor defined as product of the longest x widest perpendicular diameter, elevated catecholamine levels and tumor cels in bone marrow. Complete Response (CR)-no evidence of primary tumor or metastases. Very Good Partial Response (VGPR)-\>90% reduction of primary tumor; no metastases; no new bone lesions, all pre-existing lesions improved. Partial Response (PR)-50-90% reduction of primary tumor; \>50% reduction in measurable sites of metastases; 0-1 bone marrow samples with tumor; number of positive bone sites decreased by \>50%. Mixed Response (MR)-\>50% reduction of any measurable lesion with \<50% reduction in other sites; no new lesions; \<25% increase in any existing lesion. No Response (NR)-no new lesions; \<50% reduction but \<25% increase in an any existing lesion. No Response (NR)-no new lesions; \<50% reduction but \<25% increase in any existing legions. Progressive Disease (PD)-any new/increased measurable lesion by \>25%; previous negative marrow positive. |
| Primary | Event-free Survival (EFS) | 3 years, from time of enrollment | EFS was estimated as time to relapse, progressive disease, secondary neoplasm, or death from any cause from enrollment. The EFS was estimated by Kaplan-Meier method |
| Secondary | Feasibility of Delivering hu14.18K322A to 6 Cycles of Induction Therapy | After 6 cycles of induction therapy (approximately 24 weeks after enrollment) | The study is designed to monitor the feasibility of delivering hu14.18K332A to 6 cycles of Induction chemotherapy. The feasibility of Induction therapy for this study will be to target no worse than 75%. A patient was considered as a "failure" for the 6 cycles of Induction therapy if the patient failed to complete Induction therapy within 155 days since treatment initiation due to toxicity or disease progression, unless the delay was a result of non-medical issues (e.g. not due to protocol toxicity). The proportion of patients who successfully received hu14.18K322A with 6 cycles of induction chemotherapy was estimated together with a 95% confidence interval. The response rate (CR + VGPR + PR) to 6 cycles of Induction chemoimmunotherapy was estimated together with the 95% confidence intervals |
| Secondary | Local Failure Rate and Pattern of Failure | Up to 3 years | Local failure is defined as relapse or progression of disease at the primary site. The cumulative incidence of local failure will be estimated; competing events will include distant failure or death prior to local failure. |
| Secondary | Dose Limiting Toxicity (DLT) or Severe (Grade 3 or 4) VOD With hu14.18K322A With Allogeneic NK Cells in Consolidation | During the recovery phase after busulfan/melphalan and PBSC rescue (approximately 24-26 weeks after enrollment) | Number of patients who experience an unacceptable dose limiting toxicity (per CTCAE v 4.0) including the following toxicities: 1) toxicity requiring the use of pressors, including Grade 4 acute capillary leak syndrome or Grade3 and 4 hypotension; 2) Toxicity requiring ventilation support, including Grade 4 respiratory toxicity; 3) Grade 3 or 4 neurotoxicity with MRI evidence of new CNS thrombi, infarction or bleeding in any subject receiving the hu14.18K322A with NK cell combination; 4) Failure of recovery of ANC \> 500/mm3 by day 35 after PBSC infusion. Number of patients who experience Grade 3 or Grade 4 (per Common Toxicity Criteria v 4.0) veno occlusive disease (VOD). |
| Secondary | Dose Limiting Toxicity (DLT) | During MRD treatment cycle (approximately 8-12 months after enrollment) | Number of patients who experience an unacceptable dose limiting toxicity (per CTCAE v 4.0) including the following toxicities: 1) Toxicity requiring the use of pressors, including Grade 4 acute capillary leak syndrome or Grade 3 and 4 hypotension; 2) Toxicity requiring ventilation support, including Grade 4 respiratory toxicity; 3) Grade 3 or 4 neurotoxicity with MRI evidence of new CNS thrombi, infarction or bleeding. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Response Rate [Complete Response + Very Good Partial Response + Partial Response (CR + VGPR + PR)] | After two initial courses of chemotherapy (approximately 6 weeks after enrollment) | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | Event-free Survival (EFS) | 3 years, from time of enrollment | percent of probability | NUMBER | |
| SECONDARY | Feasibility of Delivering hu14.18K322A to 6 Cycles of Induction Therapy | After 6 cycles of induction therapy (approximately 24 weeks after enrollment) | percentage of participants | NUMBER | |
| SECONDARY | Local Failure Rate and Pattern of Failure | Up to 3 years | percentage of participants | NUMBER | |
| SECONDARY | Dose Limiting Toxicity (DLT) or Severe (Grade 3 or 4) VOD With hu14.18K322A With Allogeneic NK Cells in Consolidation | During the recovery phase after busulfan/melphalan and PBSC rescue (approximately 24-26 weeks after enrollment) | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Dose Limiting Toxicity (DLT) | During MRD treatment cycle (approximately 8-12 months after enrollment) | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Response Rate [Complete Response + Very Good Partial Response + Partial Response (CR + VGPR + PR)] | NB2012 Therapy (Including Induction, Consolidation, and MRD) Antibody (hu14.18K322A) | 42 | Participants | ||
| Event-free Survival (EFS) | NB2012 Therapy (Including Induction, Consolidation, and MRD) Plus Antibody (hu14.18K322A) | 73.7 | 95% Confidence Interval 60.0 to 83.4 | percent of probability | |
| Feasibility of Delivering hu14.18K322A to 6 Cycles of Induction Therapy | NB2012 Therapy (Including Induction, Consolidation, and MRD) Plus Antibody (hu14.18K322A) | 96.8 | 95% Confidence Interval 88.8 to 99.6 | percentage of participants | |
| Local Failure Rate and Pattern of Failure | NB2012 Therapy (Including Induction, Consolidation, and MRD) Antibody Antibody (hu14.18K322A) | 1.56 | 95% Confidence Interval 0.13 to 7.46 | percentage of participants | |
| Dose Limiting Toxicity (DLT) or Severe (Grade 3 or 4) VOD With hu14.18K322A With Allogeneic NK Cells in Consolidation | NB2012 Therapy (Including Induction, Consolidation, and MRD) Plus Antibody (hu14.18K322A) | 0 | Participants | ||
| Dose Limiting Toxicity (DLT) | NB2012 Therapy (Including Induction, Consolidation, and MRD) Plus Antibody (hu14.18K322A) | 1 | 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 | NB2012 Therapy (Including Induction, Consolidation, and MRD) Plus Antibody (hu14.18K322A) | 64 | |
| Overall Study | COMPLETED | NB2012 Therapy (Including Induction, Consolidation, and MRD) Plus Antibody (hu14.18K322A) | 54 | |
| Overall Study | NOT COMPLETED | NB2012 Therapy (Including Induction, Consolidation, and MRD) Plus Antibody (hu14.18K322A) | 10 |
Source ClinicalTrials.gov
Adverse events123
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 | Febrile neutropenia | Blood and lymphatic system disorders | NB2012 Therapy (Including Induction, Consolidation, and MRD) Plus Antibody (hu14.18K322A) | 58 | 64 | 58 |
| other | Anemia | Blood and lymphatic system disorders | NB2012 Therapy (Including Induction, Consolidation, and MRD) Plus Antibody (hu14.18K322A) | 64 | 64 | 64 |
| other | Hearing impaired | Ear and labyrinth disorders | NB2012 Therapy (Including Induction, Consolidation, and MRD) Plus Antibody (hu14.18K322A) | 20 | 64 | 20 |
| other | Mucositis oral | Gastrointestinal disorders | NB2012 Therapy (Including Induction, Consolidation, and MRD) Plus Antibody (hu14.18K322A) | 45 | 64 | 45 |
| other | Vomiting | Gastrointestinal disorders | NB2012 Therapy (Including Induction, Consolidation, and MRD) Plus Antibody (hu14.18K322A) | 27 | 64 | 27 |
| other | Nausea | Gastrointestinal disorders | NB2012 Therapy (Including Induction, Consolidation, and MRD) Plus Antibody (hu14.18K322A) | 20 | 64 | 20 |
| other | Diarrhea | Gastrointestinal disorders | NB2012 Therapy (Including Induction, Consolidation, and MRD) Plus Antibody (hu14.18K322A) | 18 | 64 | 18 |
| other | Abdominal pain | Gastrointestinal disorders | NB2012 Therapy (Including Induction, Consolidation, and MRD) Plus Antibody (hu14.18K322A) | 16 | 64 | 16 |
| other | Esophagitis | Gastrointestinal disorders | NB2012 Therapy (Including Induction, Consolidation, and MRD) Plus Antibody (hu14.18K322A) | 8 | 64 | 8 |
| other | Colitis | Gastrointestinal disorders | NB2012 Therapy (Including Induction, Consolidation, and MRD) Plus Antibody (hu14.18K322A) | 7 | 64 | 7 |
1 to 10 of 123Source ClinicalTrials.gov
See all 123 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | NB2012 Therapy (Including Induction, Consolidation, and MRD) Plus Antibody (hu14.18K322A) | 1 | 64 |
| Total, other adverse events | NB2012 Therapy (Including Induction, Consolidation, and MRD) Plus Antibody (hu14.18K322A) | 64 | 64 |
| Total, serious adverse events | NB2012 Therapy (Including Induction, Consolidation, and MRD) Plus Antibody (hu14.18K322A) | 40 | 64 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
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.
None in this release.
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/NCT01857934
GET https://conductscience.org/api/trials/v1/NCT01857934/events?page=2