Trial · NCT00578864
Protracted Etoposide During Induction Therapy for High Risk Neuroblastoma
NCT00578864, Phase 2, Completed, Baylor College of Medicine; results first posted 2012-11-06
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Protracted Etoposide During Induction Therapy for High Risk Neuroblastoma. Trials, record NCT00578864. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00578864
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Protracted Etoposide During Induction Therapy for High Risk Neuroblastoma
- NCT number
- NCT00578864
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 13 participants, actual
- Lead sponsor
- Baylor College of Medicine
- Conditions
- Neuroblastoma
- Interventions
- Protracted Oral Etoposide, Doxorubicin, IV Bolus Etoposide, Cisplatin, Cyclophosphamide, Mesna, Hematopoietic Factor, Primary tumor resection
- First posted
- 2007-12-21
- Last updated
- 2020-03-27
- Results first posted
- 2012-11-06
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Response Rate Associated With Two Cycles of Cisplatin With Protracted Oral Etoposide When Administered as Up-front Window Therapy to Previously Untreated Children With High Risk Neuroblastoma Tumors. | 2 months | Partial response or better |
| Primary | Rate of Toxicities Associated With Cisplatin With Protracted Oral Etoposide When Administered as Up-front Window Therapy to Previously Untreated Children With High Risk Neuroblastoma. | 2 months | If a patient experiences any one of the following toxicities, attributed to induction chemotherapy cycles 1, or 2, that patient will be counted as having a dose limiting toxicity. 13.2.1.1 Inability to achieve ANC \> 750 by Day 35 from start of chemotherapy cycle 1 or 2 (unless documented tumor involvement of marrow) 13.2.1.2 Inability to achieve platelet count at least 75,000 by Day 35 from start of chemotherapy cycle 1 or 2 (unless documented tumor involvement of marrow) 13.2.1.3 Any Grade 2 or greater toxicity non-hematopoietic/non-mucosal (mucositis/stomatitis) that is not reversible to Grade 1 or baseline by day 21 from start of chemotherapy cycle excluding Hematopoietic toxicity Mucositis/stomatitis Anorexia, nausea, vomiting Febrile neutropenia |
| Secondary | Overall Survival in Children With High Risk Neuroblastoma Treated on This Regimen. | 3 years | |
| Secondary | Number of Patients Who Have Surgery After the Second Cycle of Induction Therapy | 2 months | the measure is the number of patients who have surgery after two cycles of induction |
| Secondary | Event Free Survival in Children With High Risk Neuroblastoma Treated on This Regimen. | 3 years | The first of the two events (relapse or death) was chosen to represent disease free survival |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Response Rate Associated With Two Cycles of Cisplatin With Protracted Oral Etoposide When Administered as Up-front Window Therapy to Previously Untreated Children With High Risk Neuroblastoma Tumors. | 2 months | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | Rate of Toxicities Associated With Cisplatin With Protracted Oral Etoposide When Administered as Up-front Window Therapy to Previously Untreated Children With High Risk Neuroblastoma. | 2 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Overall Survival in Children With High Risk Neuroblastoma Treated on This Regimen. | 3 years | number of survival | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Patients Who Have Surgery After the Second Cycle of Induction Therapy | 2 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Event Free Survival in Children With High Risk Neuroblastoma Treated on This Regimen. | 3 years | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group10
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Response Rate Associated With Two Cycles of Cisplatin With Protracted Oral Etoposide When Administered as Up-front Window Therapy to Previously Untreated Children With High Risk Neuroblastoma Tumors. | Phase II Window With Protracted Etoposide | 1 | Participants | ||
| Response Rate Associated With Two Cycles of Cisplatin With Protracted Oral Etoposide When Administered as Up-front Window Therapy to Previously Untreated Children With High Risk Neuroblastoma Tumors. | Phase II Window With Bolus Etoposide | 2 | Participants | ||
| Rate of Toxicities Associated With Cisplatin With Protracted Oral Etoposide When Administered as Up-front Window Therapy to Previously Untreated Children With High Risk Neuroblastoma. | Phase II Window With Protracted Etoposide | 0 | Participants | ||
| Rate of Toxicities Associated With Cisplatin With Protracted Oral Etoposide When Administered as Up-front Window Therapy to Previously Untreated Children With High Risk Neuroblastoma. | Phase II Window With Bolus Etoposide | 0 | Participants | ||
| Overall Survival in Children With High Risk Neuroblastoma Treated on This Regimen. | Phase II Window With Protracted Etoposide | 3 | Participants | ||
| Overall Survival in Children With High Risk Neuroblastoma Treated on This Regimen. | Phase II Window With Bolus Etoposide | 2 | Participants | ||
| Number of Patients Who Have Surgery After the Second Cycle of Induction Therapy | Phase II Window With Protracted Etoposide | 4 | Participants | ||
| Number of Patients Who Have Surgery After the Second Cycle of Induction Therapy | Phase II Window With Bolus Etoposide | 2 | Participants | ||
| Event Free Survival in Children With High Risk Neuroblastoma Treated on This Regimen. | Phase II Window With Protracted Etoposide | 2 | Participants | ||
| Event Free Survival in Children With High Risk Neuroblastoma Treated on This Regimen. | Phase II Window With Bolus Etoposide | 1 | 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 | Phase II Window With Protracted Etoposide | 7 | |
| Overall Study | STARTED | Phase II Window With Bolus Etoposide | 6 | |
| Overall Study | COMPLETED | Phase II Window With Protracted Etoposide | 6 | |
| Overall Study | COMPLETED | Phase II Window With Bolus Etoposide | 6 | |
| Overall Study | NOT COMPLETED | Phase II Window With Protracted Etoposide | 1 | |
| Overall Study | NOT COMPLETED | Phase II Window With Bolus Etoposide | 0 |
Source ClinicalTrials.gov
Adverse events110
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 | Allergic reaction to Caspofungin | Immune system disorders | Phase II Window With Protracted Etoposide | 1 | 7 | 1 |
| other | Allergic reaction to Caspofungin | Immune system disorders | Phase II Window With Bolus Etoposide | 0 | 6 | 0 |
| other | Hearing- monitoring program | Ear and labyrinth disorders | Phase II Window With Protracted Etoposide | 1 | 7 | 1 |
| other | Hearing- monitoring program | Ear and labyrinth disorders | Phase II Window With Bolus Etoposide | 1 | 6 | 1 |
| other | ALC | Blood and lymphatic system disorders | Phase II Window With Protracted Etoposide | 2 | 7 | 9 |
| other | ALC | Blood and lymphatic system disorders | Phase II Window With Bolus Etoposide | 0 | 6 | 0 |
| other | ANC | Blood and lymphatic system disorders | Phase II Window With Protracted Etoposide | 7 | 7 | 44 |
| other | ANC | Blood and lymphatic system disorders | Phase II Window With Bolus Etoposide | 6 | 6 | 45 |
| other | Hemoglobin | Blood and lymphatic system disorders | Phase II Window With Protracted Etoposide | 7 | 7 | 47 |
| other | Hemoglobin | Blood and lymphatic system disorders | Phase II Window With Bolus Etoposide | 6 | 6 | 27 |
1 to 10 of 110Source ClinicalTrials.gov
See all 110 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Phase II Window With Protracted Etoposide | ||
| Total, all-cause mortality | Phase II Window With Bolus Etoposide | ||
| Total, other adverse events | Phase II Window With Protracted Etoposide | 7 | 7 |
| Total, other adverse events | Phase II Window With Bolus Etoposide | 6 | 6 |
| Total, serious adverse events | Phase II Window With Protracted Etoposide | 0 | 7 |
| Total, serious adverse events | Phase II Window With Bolus Etoposide | 0 | 6 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 comparisons6
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Phase II Window With Protracted Etoposide vs Phase II Window With Bolus Etoposide: Event Free Survival in Children With High Risk Neuroblastoma Treated on This Regimen. | Trial comparisons |
Phase II Window With Protracted Etoposide vs Phase II Window With Bolus Etoposide: Response Rate Associated With Two Cycles of Cisplatin With Protracted Oral Etoposide When Administered as Up-front Window Therapy to Previously Untreated Children With High Risk Neuroblastoma Tumors. | Trial comparisons |
| Phase II Window With Protracted Etoposide vs Phase II Window With Bolus Etoposide: Overall Survival in Children With High Risk Neuroblastoma Treated on This Regimen. | Trial comparisons |
| Phase II Window With Protracted Etoposide vs Phase II Window With Bolus Etoposide: Number of Patients Who Have Surgery After the Second Cycle of Induction Therapy | Trial comparisons |
Phase II Window With Protracted Etoposide vs Phase II Window With Bolus Etoposide: Rate of Toxicities Associated With Cisplatin With Protracted Oral Etoposide When Administered as Up-front Window Therapy to Previously Untreated Children With High Risk Neuroblastoma. | Trial comparisons |
| Phase II Window With Protracted Etoposide vs Phase II Window With Bolus Etoposide: 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/NCT00578864
GET https://conductscience.org/api/trials/v1/NCT00578864/events?page=2