Trial · NCT00601003
Study of Nifurtimox to Treat Refractory or Relapsed Neuroblastoma or Medulloblastoma
NCT00601003, Phase 2, Completed, Giselle Sholler; results first posted 2022-12-29
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study of Nifurtimox to Treat Refractory or Relapsed Neuroblastoma or Medulloblastoma. Trials, record NCT00601003. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00601003
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Nifurtimox to Treat Refractory or Relapsed Neuroblastoma or Medulloblastoma
- NCT number
- NCT00601003
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 112 participants, actual
- Lead sponsor
- Giselle Sholler
- Conditions
- Neuroblastoma, Medulloblastoma
- Interventions
- Nifurtimox, Cyclophosphamide, Topotecan
- First posted
- 2008-01-25
- Last updated
- 2024-08-06
- Results first posted
- 2022-12-29
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 Participants With Related Adverse Events as a Measure of Safety and Tolerability | 2 years | Test the safety of nifurtimox in children with relapsed or refractory neuroblastoma or medulloblastoma in combination with cyclophosphamide/topotecan |
| Primary | Best Radiological Response in Participants Using the RECIST Criteria | 2 years | Test the efficacy of nifurtimox in children with relapsed or refractory neuroblastoma or medulloblastoma in combination with cyclophosphamide/topotecan Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions, Overall Best Response assessed by CT or MRI, MIBG, and Bone Marrow: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions, bone marrow with CR, and MIBG with CR/PR. Overall Response (OR) = CR + PR. |
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 Participants With Related Adverse Events as a Measure of Safety and Tolerability | 2 years | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | Best Radiological Response in Participants Using the RECIST Criteria | 2 years | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group5
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Related Adverse Events as a Measure of Safety and Tolerability | Nifurtimox | 45 | Participants | ||
| Best Radiological Response in Participants Using the RECIST Criteria | Nifurtimox | Complete Response | 7 | Participants | |
| Best Radiological Response in Participants Using the RECIST Criteria | Nifurtimox | Partial Response | 11 | Participants | |
| Best Radiological Response in Participants Using the RECIST Criteria | Nifurtimox | Stable Disease | 35 | Participants | |
| Best Radiological Response in Participants Using the RECIST Criteria | Nifurtimox | Progressive Disease | 23 | 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 | Nifurtimox | 112 | |
| Overall Study | COMPLETED | Nifurtimox | 76 | |
| Overall Study | NOT COMPLETED | Nifurtimox | 36 |
Source ClinicalTrials.gov
Adverse events33
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 | Nifurtimox | 9 | 110 | |
| other | Leukopenia | Blood and lymphatic system disorders | Nifurtimox | 7 | 110 | |
| other | Neutropenia | Blood and lymphatic system disorders | Nifurtimox | 7 | 110 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Nifurtimox | 7 | 110 | |
| other | Ataxia | Nervous system disorders | Nifurtimox | 10 | 110 | |
| other | Confusion | Nervous system disorders | Nifurtimox | 6 | 110 | |
| other | Memory Impairment | Nervous system disorders | Nifurtimox | 3 | 110 | |
| other | Motor Neuropathy/Weakness | Nervous system disorders | Nifurtimox | 7 | 110 | |
| other | Peripheral Sensory Neuropathy | Nervous system disorders | Nifurtimox | 4 | 110 | |
| other | Seizures | Nervous system disorders | Nifurtimox | 5 | 110 |
1 to 10 of 33Source ClinicalTrials.gov
See all 33 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Nifurtimox | 19 | 110 |
| Total, other adverse events | Nifurtimox | 45 | 110 |
| Total, serious adverse events | Nifurtimox | 25 | 110 |
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 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/NCT00601003
GET https://conductscience.org/api/trials/v1/NCT00601003/events?page=2