CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 87 enrolled
Drug / intervention
Bevacizumab +4 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01222715
NCT01222715Phase 2Completed

A Randomized Phase II Trial of Bevacizumab (Avastin) and Temsirolimus (Torisel) in Combination With Intravenous Vinorelbine and Cyclophosphamide in Patients With Recurrent/Refractory Rhabdomyosarcoma

National Cancer Institute (NCI)·interventional·Posted Oct 18, 2010·Updated May 5, 2017

In Brief

A Phase 2 clinical trial evaluating Bevacizumab, Cyclophosphamide, and 3 other interventions for Adult Rhabdomyosarcoma and 6 related conditions. Completed, enrolled 87 participants across 184 sites in 4 countries.

Detailed 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.

Study Details

Timeline

Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedOct 18, 2010
Enrollment StartOct 1, 2010
Primary CompletionJun 1, 2015
TodayJul 2, 2026
Enrollment to primary: 4.7 yearsPosted 15.7 years ago

Interventions

Bevacizumabbiological

Given IV

Cyclophosphamidedrug

Given IV

Laboratory Biomarker Analysisother

Correlative studies

Temsirolimusdrug

Given IV

Vinorelbine Tartratedrug

Given IV