Trial · NCT02110069

A Study to Compare Vincristine to Sirolimus for Treatment of High Risk Vascular Tumors

NCT02110069, Phase 2, Terminated, Boston Children's Hospital; results first posted 2021-05-24

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Study to Compare Vincristine to Sirolimus for Treatment of High Risk Vascular Tumors. Trials, record NCT02110069. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02110069

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: A Study to Compare Vincristine to Sirolimus for Treatment of High Risk Vascular Tumors
NCT number: NCT02110069
Status: Terminated
Phases: Phase 2
Enrollment: 4 participants, actual
Lead sponsor: Boston Children's Hospital
Conditions: Kaposiform Hemangioendothelioma (KHE), Kasabach-Merritt Syndrome, Tufted Angioma
Interventions: Vincristine, Sirolimus
First posted: 2014-04-10
Last updated: 2023-09-21
Results first posted: 2021-05-24

Source ClinicalTrials.gov

Registered outcomes6

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change in Hematologic Parameters	2 months	Hematologic parameters are defined as a platelet count greater than 100,000/uL (or a 2 times increase in platelet count compared to baseline) and a fibrinogen level greater than 150mg/dl.
Primary	Number of Serious and Non-Serious Adverse Events	2 months; 12 months	Serious and non-serious adverse events will be recorded for all participants and graded using CTCAE v4.0 (Common Toxicity Criteria for Adverse Effects). Adverse event rates will be calculated for both sirolimus and vincristine.
Secondary	Evaluation of Disease Response - Maintenance	6 months; 12 months	Disease evaluation will be measured using a combination of quality of life assessments, clinical parameters, and radiologic images.
Secondary	Number of Serious and Non Serious Adverse Events - Maintenance	6 months; 12 months	Serious adverse events and adverse events will be graded according to CTCAE v4.0. Adverse event rates will be calculated for both sirolimus and vincristine.
Secondary	Change in the Serum Levels of KHE Biomarkers	Baseline, 2 months, 6 months, and 12 months	The following KHE biomarkers will be evaluated vascular endothelial growth factor A, C, and D (VEGF-A, C, D\_, IL-8 (interleukin), Pleiotrophin, IGF-1 (insulin-like growth factor), endothelin-1, thrombospondin and angiopoietin 1 and 2.
Secondary	Identify Genetic Variants in Drug Metabolism Enzymes.	Baseline	Single nucleotide polymorphism array analysis to obtain genetic information on variants in drug metabolism enzymes that affect sirolimus and vincristine metabolism.

Source ClinicalTrials.gov

Outcomes6

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population
PRIMARY	Change in Hematologic Parameters	2 months	no analysis was performed due to study being closed for low enrollment
PRIMARY	Number of Serious and Non-Serious Adverse Events	2 months; 12 months	study was closed early due to slow enrollment
SECONDARY	Evaluation of Disease Response - Maintenance	6 months; 12 months	no analysis was performed
SECONDARY	Number of Serious and Non Serious Adverse Events - Maintenance	6 months; 12 months	no data analyzed as study was closed early
SECONDARY	Change in the Serum Levels of KHE Biomarkers	Baseline, 2 months, 6 months, and 12 months	no analysis performed as study was closed early
SECONDARY	Identify Genetic Variants in Drug Metabolism Enzymes.	Baseline	study closed early due to slow enrollment

Source ClinicalTrials.gov

Results by group0

Each measurement the trial posted, group by group, in the words and numbers it posted.

None in this release.

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Vincristine	2
Overall Study	STARTED	Sirolimus	2
Overall Study	COMPLETED	Vincristine	0
Overall Study	COMPLETED	Sirolimus	2
Overall Study	NOT COMPLETED	Vincristine	2
Overall Study	NOT COMPLETED	Sirolimus	0

Source ClinicalTrials.gov

Adverse events12

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	Fever	Infections and infestations	Vincristine	1	2	1
other	Fever	Infections and infestations	Sirolimus	1	2	1
other	anemia	Blood and lymphatic system disorders	Vincristine	0	2	0
other	anemia	Blood and lymphatic system disorders	Sirolimus	2	2	2
other	Neutrophil count decreased	Blood and lymphatic system disorders	Vincristine	0	2	0
other	Neutrophil count decreased	Blood and lymphatic system disorders	Sirolimus	2	2	2
serious	Lung infection	Infections and infestations	Vincristine	1	2	1
serious	Lung infection	Infections and infestations	Sirolimus	0	2	0
serious	Lung infection	Infections and infestations	Vincristine	1	2	1
serious	Lung infection	Infections and infestations	Sirolimus	0	2	0

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Vincristine	0	2
Total, all-cause mortality	Sirolimus	0	2
Total, other adverse events	Vincristine	1	2
Total, other adverse events	Sirolimus	2	2
Total, serious adverse events	Vincristine	1	2
Total, serious adverse events	Sirolimus	1	2

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants1

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.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
R01FD004363	Phase 2 Study of Vincristine vs. Sirolimus for the Treatment of High Risk Kaposiform Hemangioendothelioma	ADAMS, DENISE MARTIN	BOSTON CHILDREN'S HOSPITAL	FOOD AND DRUG ADMINISTRATION	2014 to 2016

Source NIH RePORTER

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Vincristine vs Sirolimus: deaths from any cause	Trial comparisons
Vincristine vs Sirolimus: 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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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/NCT02110069

GET https://conductscience.org/api/trials/v1/NCT02110069/registered

API reference For AI assistants