Trial · NCT01222715

Vinorelbine Tartrate and Cyclophosphamide in Combination With Bevacizumab or Temsirolimus in Treating Patients With Recurrent or Refractory Rhabdomyosarcoma

NCT01222715, Phase 2, Completed, National Cancer Institute (NCI); results first posted 2017-05-05

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Vinorelbine Tartrate and Cyclophosphamide in Combination With Bevacizumab or Temsirolimus in Treating Patients With Recurrent or Refractory Rhabdomyosarcoma. Trials, record NCT01222715. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01222715

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Trial

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

Title: Vinorelbine Tartrate and Cyclophosphamide in Combination With Bevacizumab or Temsirolimus in Treating Patients With Recurrent or Refractory Rhabdomyosarcoma
NCT number: NCT01222715
Status: Completed
Phases: Phase 2
Enrollment: 87 participants, actual
Lead sponsor: National Cancer Institute (NCI)
Conditions: Adult Rhabdomyosarcoma, Childhood Alveolar Rhabdomyosarcoma, Childhood Pleomorphic Rhabdomyosarcoma, Childhood Rhabdomyosarcoma With Mixed Embryonal and Alveolar Features, Previously Treated Childhood Rhabdomyosarcoma, Recurrent Adult Soft Tissue Sarcoma, Recurrent Childhood Rhabdomyosarcoma
Interventions: Bevacizumab, Cyclophosphamide, Laboratory Biomarker Analysis, Temsirolimus, Vinorelbine Tartrate
First posted: 2010-10-18
Last updated: 2017-05-05
Results first posted: 2017-05-05

Source ClinicalTrials.gov

Registered outcomes9

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

List	Outcome	Time frame	Description
Primary	Event Free Survival Probability	1 year	Probability of no relapse, secondary malignancy, or death after 1 year in the study.
Primary	Rate of Dose-Limiting Toxicities	From the date of randomization until a maximum of 12 cycles (21 days per cycle) of treatment in the absence of disease progression or unacceptable toxicities.	The following events will be considered dose-limiting toxicities (DLTs): Toxicity causing delays \> 14 days in delivery of a 21-day cycle of therapy; Grade ≥ 3 mucositis \> 3 days duration; Grade ≥ 3 thromboembolic events; Grade ≥ 3 bleeding events; Grade ≥ 3 pulmonary events; Grade ≥ 3 hypertension; Grade 3 hyperglycemia (uncontrolled); Grade ≥ 4 hyperglycemia; Grade ≥ 4 hyperlipidemia (including cholesterol and triglycerides) that does not return to ≤ Grade 2 levels with appropriate medical management within 35 days; Grade ≥ 2 perforation including fistula or leak (gastrointestinal or any other organ); Grade ≥ 3 proteinuria; Grade ≥ 3 cardiac toxicity; Grade ≥ 3 intra-abdominal abscess/infection; Grade ≥ 3 wound complication (wound infection or dehiscence); Grade ≥ 1 Reversible Posterior Leukoencephalopathy Syndrome (RPLS); Grade ≥ 1 Microangiopathy, or Hemolytic-uremic syndrome (HUS) or Thrombotic thrombocytopenic Purpura (TTP).
Secondary	Response Rate (CR + PR)	From the date of randomization until a maximum of 2 cycles (21 days per cycle) of treatment in the absence of disease progression or unacceptable toxicities.	Complete or partial anatomical response rate. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Overall Response (OR) = CR + PR.
Other	Biomarker Levels	Up to 36 weeks	Biomarker data will be summarized for each response category, at each time point using either means and standard deviations or medians and ranges.
Other	Changes in Angiogenesis-associated Plasma Markers Between Patients by Treatment	Baseline up to day 42	First, the distributions of these markers will be compared at 'end of 2 cycles' between treatments using a 2-independent sample non-parametric test. The mean will also be modeled for each of these markers (or a transformation of the marker to near normality) as a function of time and treatment using GEEs which are designed to take into account the internal correlation of repeated measurements taken on the same subject. Associations between progression-free survival and changes in each of the biomarkers will be investigated using univariate Cox proportional hazards regression analysis.
Other	Clinical Predictors, Including Histologic and Molecular Subtype, Age, Stage, and Site	Up to 5 years	These known risk factors will be compared to genomic features like gene and ribonucleic acid (RNA) expression values, as well as combinations of the two and splice variants of known genes, in order to identify those features most related to treatment resistance and poor outcome (overall survival and failure-free survival) using a Cox proportional hazards model of gene expression with cross validation.
Other	Clinical Response	Up to 5 years	The data reported in 2 groups will be summarized using numbers and percentages of patients in each stratum and at each time point (baseline, after course 2, at the time of best response and end of therapy or progressive disease, whichever comes first). A binomial generalized estimating equation (GEE) model will be fitted to the data. The variables in the model will be time, treatment group and a biomarker. The beta coefficient of the biomarker will quantify the strength of the association between clinical response and the biomarker, beyond the association of the outcome to the other variables.
Other	Levels of Biomarkers Related to the Effect of Temsirolimus on the Unfolded Protein Response	Up to 36 weeks
Other	Progression-free Survival	Up to 5 years	Progression-free survival data will be explored using Kaplan Meier analysis. Associations between this outcome and each of the biomarkers will be investigated using univariate Cox proportional hazards regression analysis.

Source ClinicalTrials.gov

Outcomes9

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Event Free Survival Probability	1 year	Only eligible participants were analyzed.	Probability	NUMBER
PRIMARY	Rate of Dose-Limiting Toxicities	From the date of randomization until a maximum of 12 cycles (21 days per cycle) of treatment in the absence of disease progression or unacceptable toxicities.	Only eligible participants were analyzed.	Percentage of participants	NUMBER
SECONDARY	Response Rate (CR + PR)	From the date of randomization until a maximum of 2 cycles (21 days per cycle) of treatment in the absence of disease progression or unacceptable toxicities.	Only eligible participants with overall response evaluated were analyzed.	Proportion of participants	NUMBER
OTHER_PRE_SPECIFIED	Biomarker Levels	Up to 36 weeks
OTHER_PRE_SPECIFIED	Changes in Angiogenesis-associated Plasma Markers Between Patients by Treatment	Baseline up to day 42
OTHER_PRE_SPECIFIED	Clinical Predictors, Including Histologic and Molecular Subtype, Age, Stage, and Site	Up to 5 years
OTHER_PRE_SPECIFIED	Clinical Response	Up to 5 years
OTHER_PRE_SPECIFIED	Levels of Biomarkers Related to the Effect of Temsirolimus on the Unfolded Protein Response	Up to 36 weeks
OTHER_PRE_SPECIFIED	Progression-free Survival	Up to 5 years

Source ClinicalTrials.gov

Results by group6

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

Outcome	Group	Value	Spread	Units
Event Free Survival Probability	Regimen A	0.23	95% Confidence Interval 0.10 to 0.35	Probability
Event Free Survival Probability	Regimen B	0.43	95% Confidence Interval 0.28 to 0.58	Probability
Rate of Dose-Limiting Toxicities	Regimen A	2	95% Confidence Interval 0 to 7	Percentage of participants
Rate of Dose-Limiting Toxicities	Regimen B	21	95% Confidence Interval 9 to 34	Percentage of participants
Response Rate (CR + PR)	Regimen A	0.3250	95% Confidence Interval 0.1799 to 0.4701	Proportion of participants
Response Rate (CR + PR)	Regimen B	0.4737	95% Confidence Interval 0.3149 to 0.6324	Proportion of participants

Source ClinicalTrials.gov

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Regimen A	44
Overall Study	STARTED	Regimen B	43
Overall Study	COMPLETED	Regimen A	8
Overall Study	COMPLETED	Regimen B	16
Overall Study	NOT COMPLETED	Regimen A	36
Overall Study	NOT COMPLETED	Regimen B	27

Source ClinicalTrials.gov

Adverse events276

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	Abdominal pain	Gastrointestinal disorders	Regimen A	0	44	0
other	Abdominal pain	Gastrointestinal disorders	Regimen B	4	42	4
other	Activated partial thromboplastin time prolonged	Investigations	Regimen A	2	44	2
other	Activated partial thromboplastin time prolonged	Investigations	Regimen B	0	42	0
other	Adrenal insufficiency	Endocrine disorders	Regimen A	1	44	1
other	Adrenal insufficiency	Endocrine disorders	Regimen B	0	42	0
other	Alanine aminotransferase increased	Investigations	Regimen A	1	44	1
other	Alanine aminotransferase increased	Investigations	Regimen B	5	42	8
other	Alkaline phosphatase increased	Investigations	Regimen A	0	44	0
other	Alkaline phosphatase increased	Investigations	Regimen B	1	42	1

1 to 10 of 276Source ClinicalTrials.gov

See all 276 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Regimen A
Total, all-cause mortality	Regimen B
Total, other adverse events	Regimen A	28	44
Total, other adverse events	Regimen B	30	42
Total, serious adverse events	Regimen A	35	44
Total, serious adverse events	Regimen B	32	42

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
31513481	DERIVED

Source PubMed

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
U10CA098543	Children's Oncology Group Chair's Grant	ADAMSON, PETER C.	CHILDREN'S HOSP OF PHILADELPHIA	NATIONAL CANCER INSTITUTE	2003 to 2013

Source NIH RePORTER

Trial comparisons1

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

Comparison
Regimen A vs Regimen B: 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.

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/NCT01222715

GET https://conductscience.org/api/trials/v1/NCT01222715/events?page=2

API reference For AI assistants