Trial · NCT01767194
Irinotecan Hydrochloride and Temozolomide With Temsirolimus or Dinutuximab in Treating Younger Patients With Refractory or Relapsed Neuroblastoma
NCT01767194, Phase 2, Completed, National Cancer Institute (NCI); results first posted 2019-11-18
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Irinotecan Hydrochloride and Temozolomide With Temsirolimus or Dinutuximab in Treating Younger Patients With Refractory or Relapsed Neuroblastoma. Trials, record NCT01767194. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01767194
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Irinotecan Hydrochloride and Temozolomide With Temsirolimus or Dinutuximab in Treating Younger Patients With Refractory or Relapsed Neuroblastoma
- NCT number
- NCT01767194
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 73 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Ganglioneuroblastoma, Recurrent Neuroblastoma
- Interventions
- Dinutuximab, Irinotecan Hydrochloride, Laboratory Biomarker Analysis, Sargramostim, Temozolomide, Temsirolimus
- First posted
- 2013-01-14
- Last updated
- 2022-10-24
- Results first posted
- 2019-11-18
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Randomized Patients Who Are Responders | Up to the first 6 cycles of treatment | The percentage of patients who are responders will be tabulated, including a 95% confidence interval on the response rate. Responders are defined as patients who achieve a best overall response of complete response (CR), very good partial response (VGPR), or partial response (PR) per the International Neuroblastoma Response Criteria (INRC). Per INRC: CR= Disappearance of all target lesions. No evidence of tumor at any site; VGPR= \>90% decrease of the disease measurement for CT/MRI target lesions. All pre-existing bone lesions with CR by MIBG; MIBG scan can be stable disease (SD) or CR in soft tissue lesions corresponding to lesions on CT/MRI. CR in bone marrow. No new sites of tumor; PR= \>=30% decrease in the disease measurement for CT/MRI target lesions. Bone marrow with CR. MIBG with either PR/CR in bone lesions; MIBG may be SD or CR in soft tissue lesions corresponding to lesions on CT/MRI. Homovanillic acid (HVA)/Vanillylmandelic acid (VMA) may still be elevated. |
| Primary | Percentage of Patients in the Dinutuximab Arm Who Are Responders | Up to the first 6 cycles of treatment | Percentage of patients who are responders to therapy with dinutuximab will be tabulated, including a 95% confidence interval on the response rate. Responders are defined as patients who achieve a best overall response of complete response (CR), very good partial response (VGPR), or partial response (PR) per the International Neuroblastoma Response Criteria (INRC). Per INRC: CR= Disappearance of all target lesions. No evidence of tumor at any site; VGPR= \>90% decrease of disease measurement for CT/MRI target lesions. All pre-existing bone lesions with CR by MIBG; MIBG scan can be stable disease (SD) or CR in soft tissue lesions corresponding to lesions on CT/MRI. CR in bone marrow. No new sites of tumor; PR= ≥30% decrease in disease measurement for CT/MRI target lesions. Bone marrow with CR. MIBG with either PR/CR in bone lesions; MIBG may be SD or CR in soft tissue lesions corresponding to lesions on CT/MRI. Homovanillic acid (HVA)/ Vanillylmandelic acid (VMA) may still be elevated. |
| Other | Progression-free Survival | Up to 3 years | Kaplan-Meier method will be used to estimate progression-free survival. Progression-free survival will be defined as the time from enrollment to relapse, progressive disease, or death attributable to tumor or treatment. |
| Other | Overall Survival | Up to 3 years | Kaplan-Meier method will be used to estimate overall survival. Overall survival is defined as the time from enrollment on the study until death. |
| Other | Occurrence of Unacceptable Toxicities | Up to 1 year | The proportion of patients with at least one grade 3 or higher toxicity, graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0. |
| Other | Ability to Maintain Intended Treatment Without a Dose Reduction or Going Off Protocol Therapy for Toxicity | Up to 1 year | The proportion of patients who required a dose modification or went off protocol therapy for toxicity will be calculated for each treatment group. |
| Other | Overall Response | Up to the first 6 cycles of treatment | The proportion of patients achieving each type of overall response (complete response, partial response, stable disease, progressive disease) will be calculated according to the International Neuroblastoma Response Criteria (INRC). |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Randomized Patients Who Are Responders | Up to the first 6 cycles of treatment | Includes all eligible patients randomly assigned to Arm I or Arm II. Of the 19 participants randomized to Arm I, one was ineligible and not included in the analysis. Of the 54 participants assigned to Arm II, 1 was ineligible and 36 were non-randomly assigned, and not included in the analysis. | Percentage of patients | NUMBER |
| PRIMARY | Percentage of Patients in the Dinutuximab Arm Who Are Responders | Up to the first 6 cycles of treatment | Includes all eligible patients either randomized or non-randomly assigned to Arm II. Of the 54 participants assigned to Arm II, 1 was ineligible and not included in the analysis. The remaining 53 eligible participants are included in the analysis, 17 randomized and 36 non-randomly assigned to Arm II. | Percentage of patients | NUMBER |
| OTHER_PRE_SPECIFIED | Progression-free Survival | Up to 3 years | |||
| OTHER_PRE_SPECIFIED | Overall Survival | Up to 3 years | |||
| OTHER_PRE_SPECIFIED | Occurrence of Unacceptable Toxicities | Up to 1 year | |||
| OTHER_PRE_SPECIFIED | Ability to Maintain Intended Treatment Without a Dose Reduction or Going Off Protocol Therapy for Toxicity | Up to 1 year | |||
| OTHER_PRE_SPECIFIED | Overall Response | Up to the first 6 cycles of treatment |
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 Randomized Patients Who Are Responders | Arm I (Temozolomide, Irinotecan Hydrochloride, Temsirolimus) | 5.6 | 95% Confidence Interval 0.0 to 16.1 | Percentage of patients | |
| Percentage of Randomized Patients Who Are Responders | Arm II (Temozolomide, Irinotecan Hydrochloride, Dinutuximab) | 52.9 | 95% Confidence Interval 29.2 to 76.7 | Percentage of patients | |
| Percentage of Patients in the Dinutuximab Arm Who Are Responders | Arm II (Temozolomide, Irinotecan Hydrochloride, Dinutuximab) | 41.2 | 95% Confidence Interval 28.2 to 54.8 | Percentage of patients |
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 | Arm I (Temozolomide, Irinotecan Hydrochloride, Temsirolimus) | 19 | |
| Overall Study | STARTED | Arm II (Temozolomide, Irinotecan Hydrochloride, Dinutuximab) | 54 | |
| Overall Study | COMPLETED | Arm I (Temozolomide, Irinotecan Hydrochloride, Temsirolimus) | 1 | |
| Overall Study | COMPLETED | Arm II (Temozolomide, Irinotecan Hydrochloride, Dinutuximab) | 11 | |
| Overall Study | NOT COMPLETED | Arm I (Temozolomide, Irinotecan Hydrochloride, Temsirolimus) | 18 | |
| Overall Study | NOT COMPLETED | Arm II (Temozolomide, Irinotecan Hydrochloride, Dinutuximab) | 43 |
Source ClinicalTrials.gov
Adverse events224
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 | Abdominal pain | Gastrointestinal disorders | Arm I (Temozolomide, Irinotecan Hydrochloride, Temsirolimus) | 0 | 18 | |
| other | Abdominal pain | Gastrointestinal disorders | Arm II (Temozolomide, Irinotecan Hydrochloride, Dinutuximab) | 3 | 51 | |
| other | Activated partial thromboplastin time prolonged | Investigations | Arm I (Temozolomide, Irinotecan Hydrochloride, Temsirolimus) | 0 | 18 | |
| other | Activated partial thromboplastin time prolonged | Investigations | Arm II (Temozolomide, Irinotecan Hydrochloride, Dinutuximab) | 1 | 51 | |
| other | Alanine aminotransferase increased | Investigations | Arm I (Temozolomide, Irinotecan Hydrochloride, Temsirolimus) | 4 | 18 | |
| other | Alanine aminotransferase increased | Investigations | Arm II (Temozolomide, Irinotecan Hydrochloride, Dinutuximab) | 8 | 51 | |
| other | Allergic reaction | Immune system disorders | Arm I (Temozolomide, Irinotecan Hydrochloride, Temsirolimus) | 0 | 18 | |
| other | Allergic reaction | Immune system disorders | Arm II (Temozolomide, Irinotecan Hydrochloride, Dinutuximab) | 1 | 51 | |
| other | Anemia | Blood and lymphatic system disorders | Arm I (Temozolomide, Irinotecan Hydrochloride, Temsirolimus) | 5 | 18 | |
| other | Anemia | Blood and lymphatic system disorders | Arm II (Temozolomide, Irinotecan Hydrochloride, Dinutuximab) | 12 | 51 |
1 to 10 of 224Source ClinicalTrials.gov
See all 224 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm I (Temozolomide, Irinotecan Hydrochloride, Temsirolimus) | 12 | 18 |
| Total, all-cause mortality | Arm II (Temozolomide, Irinotecan Hydrochloride, Dinutuximab) | 15 | 51 |
| Total, other adverse events | Arm I (Temozolomide, Irinotecan Hydrochloride, Temsirolimus) | 10 | 18 |
| Total, other adverse events | Arm II (Temozolomide, Irinotecan Hydrochloride, Dinutuximab) | 39 | 51 |
| Total, serious adverse events | Arm I (Temozolomide, Irinotecan Hydrochloride, Temsirolimus) | 5 | 18 |
| Total, serious adverse events | Arm II (Temozolomide, Irinotecan Hydrochloride, Dinutuximab) | 18 | 51 |
Source ClinicalTrials.gov
Papers3
The papers the trial lists on ClinicalTrials.gov.
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Arm I (Temozolomide, Irinotecan Hydrochloride, Temsirolimus) vs Arm II (Temozolomide, Irinotecan Hydrochloride, Dinutuximab): deaths from any cause | Trial comparisons |
| Arm I (Temozolomide, Irinotecan Hydrochloride, Temsirolimus) vs Arm II (Temozolomide, Irinotecan Hydrochloride, Dinutuximab): serious adverse events | 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/NCT01767194
GET https://conductscience.org/api/trials/v1/NCT01767194/events?page=2