Trial · NCT00311584
Irinotecan and Temozolomide in Treating Young Patients With Recurrent Neuroblastoma
NCT00311584, Phase 2, Completed, Children's Oncology Group; results first posted 2014-01-16
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Irinotecan and Temozolomide in Treating Young Patients With Recurrent Neuroblastoma. Trials, record NCT00311584. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00311584
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Irinotecan and Temozolomide in Treating Young Patients With Recurrent Neuroblastoma
- NCT number
- NCT00311584
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 59 participants, actual
- Lead sponsor
- Children's Oncology Group
- Conditions
- Neuroblastoma
- Interventions
- irinotecan hydrochloride, temozolomide
- First posted
- 2006-04-06
- Last updated
- 2014-09-30
- Results first posted
- 2014-01-16
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Response - Complete Response (CR), Very Good Partial Response (VGPR) and Partial Response (PR) | up to 6 courses of therapy, or about 6 months | The patient's best overall response obtained during Reporting Periods 1 and 2 will be scored as "best response". Patients enrolled on Stratum 1 with bone marrow disease, a responder has no tumor cells detectable by routine morphology on 2 subsequent bilateral bone marrow aspirates and biopsies done at least 3 weeks apart. For patients enrolled on stratum 1 with MIBG only disease, response will be assessed using the Curie scale. Patients who have complete resolution of all MIBG positive lesions (CR) or resolution of at least one MIBG positive lesion with persistence of other lesions (PR) will be considered responders. For Stratum 2 a responder is defined to be a patient who achieves a best overall response of CR, VGPR or PR from CT/MRI scans from central review using (RECIST) Response Evaluation Criteria in Solid Tumor. A responder is defined to be a patient who achieves a best overall response of CR (Complete Response), VGPR (Very Good Partial Response) or PR (Partial Response). |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Response - Complete Response (CR), Very Good Partial Response (VGPR) and Partial Response (PR) | up to 6 courses of therapy, or about 6 months | Patients were evaluable for inclusion in the analysis of response if eligible, had an event (relapse, PD, death or secondary malignancy) any time after enrollment, or completed at least 2 courses of Irinotecan/Temozolomide therapy. Patients off therapy before completion of 2 courses by choice or toxicity were not evaluable for response analysis. | participants | NUMBER |
Source ClinicalTrials.gov
Results by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Response - Complete Response (CR), Very Good Partial Response (VGPR) and Partial Response (PR) | Disease Eval by Bone Marrow or MIBG (Irinotecan/Temozolomide) | 5 | participants | ||
| Overall Response - Complete Response (CR), Very Good Partial Response (VGPR) and Partial Response (PR) | Disease Measurable by CT or MRI Scan (Irinotecan/Temozolomide) | 3 | 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 Eval by Bone Marrow or MIBG (Irinotecan/Temozolomide) | 29 | |
| Overall Study | STARTED | Disease Measurable by CT or MRI Scan (Irinotecan/Temozolomide) | 30 | |
| Overall Study | COMPLETED | Disease Eval by Bone Marrow or MIBG (Irinotecan/Temozolomide) | 9 | |
| Overall Study | COMPLETED | Disease Measurable by CT or MRI Scan (Irinotecan/Temozolomide) | 7 | |
| Overall Study | NOT COMPLETED | Disease Eval by Bone Marrow or MIBG (Irinotecan/Temozolomide) | 20 | |
| Overall Study | NOT COMPLETED | Disease Measurable by CT or MRI Scan (Irinotecan/Temozolomide) | 23 |
Source ClinicalTrials.gov
Adverse events40
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 | ALT, SGPT (serum glutamic pyruvic transaminase) | Investigations | Disease Eval by Bone Marrow or MIBG (Irinotecan/Temozolomide) | 3 | 27 | |
| other | ALT, SGPT (serum glutamic pyruvic transaminase) | Investigations | Disease Measurable by CT or MRI Scan (Irinotecan/Temozolomide) | 3 | 28 | |
| other | AST: AST, SGOT(serum glutamic oxaloacetic transaminase) | Investigations | Disease Eval by Bone Marrow or MIBG (Irinotecan/Temozolomide) | 4 | 27 | |
| other | AST: AST, SGOT(serum glutamic oxaloacetic transaminase) | Investigations | Disease Measurable by CT or MRI Scan (Irinotecan/Temozolomide) | 2 | 28 | |
| other | Alkaline phosphatase | Investigations | Disease Eval by Bone Marrow or MIBG (Irinotecan/Temozolomide) | 0 | 27 | |
| other | Alkaline phosphatase | Investigations | Disease Measurable by CT or MRI Scan (Irinotecan/Temozolomide) | 2 | 28 | |
| other | Constipation | Gastrointestinal disorders | Disease Eval by Bone Marrow or MIBG (Irinotecan/Temozolomide) | 0 | 27 | |
| other | Constipation | Gastrointestinal disorders | Disease Measurable by CT or MRI Scan (Irinotecan/Temozolomide) | 2 | 28 | |
| other | Fatigue (asthenia, lethargy, malaise) | General disorders | Disease Eval by Bone Marrow or MIBG (Irinotecan/Temozolomide) | 2 | 27 | |
| other | Fatigue (asthenia, lethargy, malaise) | General disorders | Disease Measurable by CT or MRI Scan (Irinotecan/Temozolomide) | 0 | 28 |
1 to 10 of 40Source ClinicalTrials.gov
See all 40 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Disease Eval by Bone Marrow or MIBG (Irinotecan/Temozolomide) | ||
| Total, all-cause mortality | Disease Measurable by CT or MRI Scan (Irinotecan/Temozolomide) | ||
| Total, other adverse events | Disease Eval by Bone Marrow or MIBG (Irinotecan/Temozolomide) | 13 | 27 |
| Total, other adverse events | Disease Measurable by CT or MRI Scan (Irinotecan/Temozolomide) | 8 | 28 |
| Total, serious adverse events | Disease Eval by Bone Marrow or MIBG (Irinotecan/Temozolomide) | 0 | 27 |
| Total, serious adverse events | Disease Measurable by CT or MRI Scan (Irinotecan/Temozolomide) | 1 | 28 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 21115869 | RESULT |
Source PubMed
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
Disease Eval by Bone Marrow or MIBG (Irinotecan/Temozolomide) vs Disease Measurable by CT or MRI Scan (Irinotecan/Temozolomide): Overall Response - Complete Response (CR), Very Good Partial Response (VGPR) and Partial Response (PR) | Trial comparisons |
| Disease Eval by Bone Marrow or MIBG (Irinotecan/Temozolomide) vs Disease Measurable by CT or MRI Scan (Irinotecan/Temozolomide): 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/NCT00311584
GET https://conductscience.org/api/trials/v1/NCT00311584/events?page=2