Trial · NCT00993044
A Study of Vincristine, Escalating Doses of Irinotecan, Temozolomide and Bevacizumab (Vit-b) in Pediatric and Adolescent Patients With Recurrent or Refractory Solid Tumors of Non-hematopoietic Origin
NCT00993044, Phase 1, Completed, Children's Hospital Los Angeles; results first posted 2014-07-23
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study of Vincristine, Escalating Doses of Irinotecan, Temozolomide and Bevacizumab (Vit-b) in Pediatric and Adolescent Patients With Recurrent or Refractory Solid Tumors of Non-hematopoietic Origin. Trials, record NCT00993044. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00993044
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Vincristine, Escalating Doses of Irinotecan, Temozolomide and Bevacizumab (Vit-b) in Pediatric and Adolescent Patients With Recurrent or Refractory Solid Tumors of Non-hematopoietic Origin
- NCT number
- NCT00993044
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 13 participants, actual
- Lead sponsor
- Children's Hospital Los Angeles
- Conditions
- Refractory Solid Tumors in Children
- Interventions
- Irinotecan, Vincristine, Temozolomide, Bevacizumab
- First posted
- 2009-10-09
- Last updated
- 2023-10-06
- Results first posted
- 2014-07-23
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Dose Limiting Toxicity | 2 years | Number of participants with dose limiting toxicity events |
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 | Dose Limiting Toxicity | 2 years | participants | NUMBER |
Source ClinicalTrials.gov
Results by group1
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Dose Limiting Toxicity | Single Arm | 2 | participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Irinotecan 30 mg | STARTED | Single Arm | 6 | |
| Irinotecan 30 mg | COMPLETED | Single Arm | 6 | |
| Irinotecan 30 mg | NOT COMPLETED | Single Arm | 0 | |
| Irinotecan 50 mg | STARTED | Single Arm | 7 | |
| Irinotecan 50 mg | COMPLETED | Single Arm | 6 | |
| Irinotecan 50 mg | NOT COMPLETED | Single Arm | 1 |
Source ClinicalTrials.gov
Adverse events10
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 | Dose Level 1 | 6 | 6 | |
| other | Anemia | Blood and lymphatic system disorders | Dose Level 2 | 6 | 6 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Dose Level 1 | 6 | 6 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Dose Level 2 | 6 | 6 | |
| other | Neutropenia | Blood and lymphatic system disorders | Dose Level 1 | 6 | 6 | |
| other | Neutropenia | Blood and lymphatic system disorders | Dose Level 2 | 6 | 6 | |
| serious | Hyperbilirubinemia | Hepatobiliary disorders | Dose Level 1 | 1 | 6 | 1 |
| serious | Hyperbilirubinemia | Hepatobiliary disorders | Dose Level 2 | 0 | 6 | |
| serious | colitis | Gastrointestinal disorders | Dose Level 1 | 0 | 6 | |
| serious | colitis | Gastrointestinal disorders | Dose Level 2 | 1 | 6 | 1 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Dose Level 1 | ||
| Total, all-cause mortality | Dose Level 2 | ||
| Total, other adverse events | Dose Level 1 | 6 | 6 |
| Total, other adverse events | Dose Level 2 | 6 | 6 |
| Total, serious adverse events | Dose Level 1 | 1 | 6 |
| Total, serious adverse events | Dose Level 2 | 1 | 6 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 23894304 | 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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Dose Level 1 vs Dose Level 2: serious adverse events |
Source 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/NCT00993044
GET https://conductscience.org/api/trials/v1/NCT00993044/registered