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

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

Eligibility Criteria

Sex

ALL

Age

N/A - 29 Years

Healthy Volunteers

Not accepted

Interventions

• Bevacizumab — BIOLOGICAL
  Given IV
• Cyclophosphamide — DRUG
  Given IV
• Laboratory Biomarker Analysis — OTHER
  Correlative studies
• Temsirolimus — DRUG
  Given IV
• Vinorelbine Tartrate — DRUG
  Given IV

Study Details

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.

Key Dates

Start date

Oct 31, 2010

Status verified

Mar 2017

Primary completion

Jun 30, 2015

Completion

Jun 30, 2015

Study Design

Enrollment

87 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Arm I (vinorelbine tartrate, cyclophosphamide, bevacizumab)
  Patients receive vinorelbine tartrate IV over 6-10 minutes on days 1 and 8 and cyclophosphamide IV over 30-60 minutes on day 1. Patients also receive bevacizumab IV over 30-90 minutes on day 1.
• Experimental: Arm II (vinorelbine tartrate, cyclophosphamide, temsirolimus)
  Patients receive vinorelbine tartrate and cyclophosphamide as in arm I. Patients also receive temsirolimus IV over 30-60 minutes on days 1, 8, and 15.

Primary Outcome Measure

Event Free Survival Probability [ Time Frame: 1 year ]

Locations (163)

Find similar trials in Birmingham, AL

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