Clinical trialNCT01222715CompletedPhase 2Interventional

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

SponsorNational Cancer Institute (NCI)Enrollment87Adult RhabdomyosarcomaChildhood Alveolar RhabdomyosarcomaChildhood Pleomorphic RhabdomyosarcomaChildhood Rhabdomyosarcoma With Mixed Embryonal and Alveolar FeaturesPreviously Treated Childhood RhabdomyosarcomaRecurrent Adult Soft Tissue Sarcoma+1 more conditions

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

This randomized phase II trial studies how well vinorelbine tartrate and cyclophosphamide work in combination with bevacizumab or temsirolimus in treating patients with recurrent or refractory rhabdomyosarcoma. Drugs used in chemotherapy, such as vinorelbine tartrate and cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of rhabdomyosarcoma by blocking blood flow to the tumor. Temsirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether combination chemotherapy is more effective when given together with bevacizumab or temsirolimus in treating rhabdomyosarcoma.

clinicaltrials.gov ↗

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

Leo Mascarenhas
Children's Oncology Group
Principal Investigator
clinicaltrials.gov ↗

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

184 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

Australia

Sydney Children'S Hospital
Randwick, New South Wales, Australia
the Children'S Hospital at Westmead
Westmead, New South Wales, Australia
Princess Margaret Hospital for Children
Perth, Western Australia, Australia

Canada

Alberta Children'S Hospital
Calgary, Alberta, Canada
University of Alberta Hospital
Edmonton, Alberta, Canada
British Columbia Children'S Hospital
Vancouver, British Columbia, Canada
Cancercare Manitoba
Winnipeg, Manitoba, Canada
Janeway Child Health Centre
St. John's, Newfoundland and Labrador, Canada
Iwk Health Centre
Halifax, Nova Scotia, Canada
Chedoke Hospital at Hamilton Health Sciences
Hamilton, Ontario, Canada
Mcmaster Children'S Hospital at Hamilton Health Sciences
Hamilton, Ontario, Canada
Cancer Centre of Southeastern Ontario at Kingston General Hospital
Kingston, Ontario, Canada
Children'S Hospital
London, Ontario, Canada
Hospital for Sick Children
Toronto, Ontario, Canada
Centre Hospitalier Universitaire Sainte-Justine
Montreal, Quebec, Canada
the Montreal Children'S Hospital of the Muhc
Montreal, Quebec, Canada
Centre Hospitalier Universitaire de Quebec
Québec, Quebec, Canada
Allan Blair Cancer Centre
Regina, Saskatchewan, Canada
Saskatoon Cancer Centre
Saskatoon, Saskatchewan, Canada

New Zealand

Starship Children'S Hospital
Grafton, Auckland, New Zealand
Christchurch Hospital
Christchurch, New Zealand

United States

Children'S Hospital of Alabama
Birmingham, Alabama, United States
University of Alabama at Birmingham Cancer Center
Birmingham, Alabama, United States
Phoenix Childrens Hospital
Phoenix, Arizona, United States
Arkansas Children'S Hospital
Little Rock, Arkansas, United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
Southern California Permanente Medical Group
Downey, California, United States
City of Hope Comprehensive Cancer Center
Duarte, California, United States
Loma Linda University Medical Center
Loma Linda, California, United States
Miller Children'S and Women'S Hospital Long Beach
Long Beach, California, United States
Cedars-Sinai Medical Center
Los Angeles, California, United States
Children'S Hospital Los Angeles
Los Angeles, California, United States
Children'S Hospital Central California
Madera, California, United States
Children'S Hospital and Research Center at Oakland
Oakland, California, United States
Children'S Hospital of Orange County
Orange, California, United States
Lucile Packard Children'S Hospital Stanford University
Palo Alto, California, United States
University of California Davis Comprehensive Cancer Center
Sacramento, California, United States
Rady Children'S Hospital - San Diego
San Diego, California, United States
Ucsf Medical Center-Parnassus
San Francisco, California, United States
Children'S Hospital Colorado
Aurora, Colorado, United States

144 more sites on the registry record.ClinicalTrials.gov ↗

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Bevacizumab →Cyclophosphamide →Temsirolimus →Vinorelbine →

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 31 Oct 2010
Primary completion: 30 Jun 2015
Completion: 30 Jun 2015
Last update posted: 5 May 2017
Registered enrollment: 87
Registry id: NCT01222715

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.