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Vinorelbine Tartrate and Cyclophosphamide in Combination With Bevacizumab or Temsirolimus in Treating Patients With Recurrent or Refractory Rhabdomyosarcoma
NCT01222715 · View on ClinicalTrials.gov ↗
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.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 87 participants |
| Start Date | 2010-10 |
| Est. Completion | 2015-06 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01222715
The ClinicalTrials.gov registry entry for NCT01222715 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 87 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 2,390 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT01222715 reports 20 study locations spanning 5 distinct geographic areas — top geographies include California, Alabama, Arkansas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT01222715?
This trial is sponsored by National Cancer Institute (NCI), which has 2,390 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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