Trial · NCT00555464
Clinical Trial of Vincristine vs. Prednisolone for Treatment of Complicated Hemangiomas
NCT00555464, Phase 2, Terminated, Medical College of Wisconsin; results first posted 2013-06-11
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Clinical Trial of Vincristine vs. Prednisolone for Treatment of Complicated Hemangiomas. Trials, record NCT00555464. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00555464
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Clinical Trial of Vincristine vs. Prednisolone for Treatment of Complicated Hemangiomas
- NCT number
- NCT00555464
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 8 participants, actual
- Lead sponsor
- Medical College of Wisconsin
- Conditions
- Hemangioma
- Interventions
- Vincristine, Prednisone
- First posted
- 2007-11-08
- Last updated
- 2013-06-11
- Results first posted
- 2013-06-11
- Limitations and caveats
- The limitations of this trial include early termination of enrollment leading to small numbers of subjects analyzed.
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Response of Hemangioma (IH) to Treatment | 6 weeks | Response of IH not confined to the dermis will be coded using the following criteria: Progressive disease: \>40% increase in volume by MRI, Partial response: \>65% reduction in volume by MRI, Complete response: no visual or radiographic evidence of disease, Stable disease: none of the above or \<40% increase or \<65% decrease in volume by MRI. Response of superficial IH will be coded using the following criteria (based on RECIST): Progressive disease: \>30% increase in IH size, Partial response: \>30% reduction in size, Complete response: no evidence of disease, Stable disease: none of the above. Our first 3 patients showed limits to using MRI volume to measure IH size/response to therapy. Unlike other solid tumors, the superficial distribution of some IH made getting volume by MRI difficult, resulting in smaller tumor estimation compared to clinical assessment. Based on these observations, we amended the protocol to report response based on RECIST criteria instead of change in IH volume. |
| Secondary | Toxicity to Medications | Initial visit, 2, 4, 6, 10 and 12 weeks of therapy | Adverse events were closely monitored and recorded at weekly visits during treatment period and for two years after treatment ceased. Laboratory values were taken every other week during the treatment period. Please see Adverse Events module for more details. |
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 | Response of Hemangioma (IH) to Treatment | 6 weeks | Per protocol, all participants were analyzed, no matter the treatment arm or treatment success. | participants | NUMBER |
| SECONDARY | Toxicity to Medications | Initial visit, 2, 4, 6, 10 and 12 weeks of therapy | participants | NUMBER |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Response of Hemangioma (IH) to Treatment | Vincristine Treatment Group | Progressive Disease | 0 | participants | |
| Response of Hemangioma (IH) to Treatment | Oral Steroid Treatment Group | Progressive Disease | 1 | participants | |
| Response of Hemangioma (IH) to Treatment | Vincristine Treatment Group | Partial Response | 2 | participants | |
| Response of Hemangioma (IH) to Treatment | Oral Steroid Treatment Group | Partial Response | 0 | participants | |
| Response of Hemangioma (IH) to Treatment | Vincristine Treatment Group | Complete Response | 0 | participants | |
| Response of Hemangioma (IH) to Treatment | Oral Steroid Treatment Group | Complete Response | 0 | participants | |
| Response of Hemangioma (IH) to Treatment | Vincristine Treatment Group | Stable Disease | 2 | participants | |
| Response of Hemangioma (IH) to Treatment | Oral Steroid Treatment Group | Stable Disease | 2 | participants | |
| Toxicity to Medications | Vincristine Treatment Group | Patients with Serious Adverse Events | 0 | participants | |
| Toxicity to Medications | Oral Steroid Treatment Group | Patients with Serious Adverse Events | 0 | participants |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Vincristine Treatment Group | 4 | |
| Overall Study | STARTED | Oral Steroid Treatment Group | 4 | |
| Overall Study | COMPLETED | Vincristine Treatment Group | 4 | |
| Overall Study | COMPLETED | Oral Steroid Treatment Group | 1 | |
| Overall Study | NOT COMPLETED | Vincristine Treatment Group | 0 | |
| Overall Study | NOT COMPLETED | Oral Steroid Treatment Group | 3 |
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 | Gastrointestinal: weight loss | Gastrointestinal disorders | Vincristine Treatment Group | 1 | 4 | 1 |
| other | Gastrointestinal: weight loss | Gastrointestinal disorders | Oral Steroid Treatment Group | 0 | 4 | 0 |
| other | Anemia | Blood and lymphatic system disorders | Vincristine Treatment Group | 3 | 4 | 5 |
| other | Anemia | Blood and lymphatic system disorders | Oral Steroid Treatment Group | 0 | 4 | 0 |
| other | obstruction/stenosis of airway | Respiratory, thoracic and mediastinal disorders | Vincristine Treatment Group | 1 | 4 | 1 |
| other | obstruction/stenosis of airway | Respiratory, thoracic and mediastinal disorders | Oral Steroid Treatment Group | 0 | 4 | 0 |
| other | Infection with normal ANC | Infections and infestations | Vincristine Treatment Group | 1 | 4 | 1 |
| other | Infection with normal ANC | Infections and infestations | Oral Steroid Treatment Group | 0 | 4 | 0 |
| other | Rash/desquamation | Skin and subcutaneous tissue disorders | Vincristine Treatment Group | 1 | 4 | 1 |
| other | Rash/desquamation | Skin and subcutaneous tissue disorders | Oral Steroid Treatment Group | 0 | 4 | 0 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Vincristine Treatment Group | ||
| Total, all-cause mortality | Oral Steroid Treatment Group | ||
| Total, other adverse events | Vincristine Treatment Group | 3 | 4 |
| Total, other adverse events | Oral Steroid Treatment Group | 0 | 4 |
| Total, serious adverse events | Vincristine Treatment Group | 0 | 4 |
| Total, serious adverse events | Oral Steroid Treatment Group | 0 | 4 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 8607636 | BACKGROUND |
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 |
|---|
| Vincristine Treatment Group vs Oral Steroid Treatment Group: 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/NCT00555464
GET https://conductscience.org/api/trials/v1/NCT00555464/registered