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NCT01222715 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study of Recurrent Adult Soft Tissue Sarcoma and Recurrent Childhood Rhabdomyosarcoma, sponsored by National Cancer Institute (NCI).

Completed
Registry status
Phase 2
Development phase
87
Enrollment target
20
Study locations

NCT01222715: Completed Phase 2 study of Recurrent Adult Soft Tissue Sarcoma and Recurrent Childhood Rhabdomyosarcoma, sponsored by National Cancer Institute (NCI).

NCT01222715 is a Phase 2 study of Recurrent Adult Soft Tissue Sarcoma and Recurrent Childhood Rhabdomyosarcoma that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 87 participants, roughly in line with the 81-participant average among 11 other Recurrent Adult Soft Tissue Sarcoma trials with a reported enrollment target. The trial reports 20 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01222715, a Phase 2 study of Recurrent Adult Soft Tissue Sarcoma and Recurrent Childhood Rhabdomyosarcoma, has completed, sponsored by National Cancer Institute (NCI).

COMPLETED
Registry status
Phase 2
Development phase
87 participants
Enrollment target
20
Study locations

Study Summary

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.

Primary Outcome

Probability of no relapse, secondary malignancy, or death after 1 year in the study.

Conditions Studied

Recurrent Adult Soft Tissue Sarcoma Recurrent Childhood Rhabdomyosarcoma Adult Rhabdomyosarcoma Previously Treated Childhood Rhabdomyosarcoma Childhood Alveolar Rhabdomyosarcoma Childhood Pleomorphic Rhabdomyosarcoma Childhood Rhabdomyosarcoma With Mixed Embryonal and Alveolar Features

Interventions

  • DRUG Cyclophosphamide
  • OTHER Laboratory Biomarker Analysis
  • BIOLOGICAL Bevacizumab
  • DRUG Temsirolimus
  • DRUG Vinorelbine Tartrate

Study Locations (20)

California

  • Southern California Permanente Medical Group - Downey
  • City of Hope Comprehensive Cancer Center - Duarte
  • Loma Linda University Medical Center - Loma Linda
  • Miller Children's and Women's Hospital Long Beach - Long Beach
  • Children's Hospital Los Angeles - Los Angeles
  • Cedars-Sinai Medical Center - Los Angeles
  • Children's Hospital Central California - Madera
  • Children's Hospital and Research Center at Oakland - Oakland
  • Children's Hospital of Orange County - Orange
  • Lucile Packard Children's Hospital Stanford University - Palo Alto
  • University of California Davis Comprehensive Cancer Center - Sacramento
  • Rady Children's Hospital - San Diego - San Diego
  • UCSF Medical Center-Parnassus - San Francisco

Alabama

  • Children's Hospital of Alabama - Birmingham
  • University of Alabama at Birmingham Cancer Center - Birmingham

Arkansas

  • Arkansas Children's Hospital - Little Rock
  • University of Arkansas for Medical Sciences - Little Rock

Colorado

  • Children's Hospital Colorado - Aurora
  • Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center - Denver

Arizona

  • Phoenix Childrens Hospital - Phoenix

Trial Details

FieldValue
Enrollment Target 87 participants
Start Date 2010-10
Est. Completion 2015-06
Phase Phase 2
National Cancer Institute (NCI)

3,257 total trials

What the finished NCT01222715 record still lists

NCT01222715 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 87 participants, a relatively small participant target, roughly in line with the 81-participant average among 11 other Recurrent Adult Soft Tissue Sarcoma trials with a reported enrollment target.

The record links to 7 conditions, with Recurrent Adult Soft Tissue Sarcoma appearing as the primary indexed condition, and to 5 interventions - of which Cyclophosphamide is the first listed.

NCT01222715 names 20 study sites across 5 states, led by California, Alabama, Arkansas.

Frequently Asked Questions

What is clinical trial NCT01222715 about?

NCT01222715 is a clinical study titled "Vinorelbine Tartrate and Cyclophosphamide in Combination With Bevacizumab or Temsirolimus in Treating Patients With Recurrent or Refractory Rhabdomyosarcoma". 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 di...

What is the current status of trial NCT01222715?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 87 participants. The study started on 2010-10. Estimated completion is 2015-06.

What conditions does trial NCT01222715 study?

This clinical trial studies the following conditions: Recurrent Adult Soft Tissue Sarcoma, Recurrent Childhood Rhabdomyosarcoma, Adult Rhabdomyosarcoma, Previously Treated Childhood Rhabdomyosarcoma, Childhood Alveolar Rhabdomyosarcoma.

What interventions are being tested in trial NCT01222715?

The interventions under investigation include: Cyclophosphamide (DRUG), Laboratory Biomarker Analysis (OTHER), Bevacizumab (BIOLOGICAL), Temsirolimus (DRUG), Vinorelbine Tartrate (DRUG).

Who is sponsoring clinical trial NCT01222715?

This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01222715 being conducted?

This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Recurrent Adult Soft Tissue Sarcoma

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT01222715's enrollment target sits among peer trials

87 5th of 11 higher than 7 of 11 other Recurrent Adult Soft Tissue Sarcoma trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Recurrent Adult Soft Tissue Sarcoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Related registry views

Source: ClinicalTrials.gov NCT01222715, the US trial registry maintained by the National Library of Medicine. NCT01222715 (small enrollment · wide site footprint · completed) retrieved and formatted by PlainTrial, see methodology.