Vincristine Sulfate, Topotecan Hydrochloride, and Cyclophosphamide With or Without Bevacizumab in Treating Young Patients With Refractory or First Recurrent Extracranial Ewing Sarcoma

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT00516295
Phase
PHASE2
Status
Completed

Conditions

  • Ewing Sarcoma of Bone
  • Extraosseous Ewing Sarcoma
  • Peripheral Primitive Neuroectodermal Tumor
  • Recurrent Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor

Eligibility Criteria

Sex
ALL
Age
1 Year - 29 Years
Healthy Volunteers
Not accepted

Interventions

  • topotecan hydrochloride — DRUG
    Given IV
  • vincristine sulfate — DRUG
    Given IV
  • cyclophosphamide — DRUG
    Given IV
  • bevacizumab — BIOLOGICAL
    Given IV

Study Details

This phase II trial study has a 6-patient feasibility portion studying the tolerability of chemotherapy with vincristine sulfate together with topotecan hydrochloride, cyclophosphamide, and bevacizumab in treating young patients with refractory or first recurrent extracranial Ewing's sarcoma. If the therapy is considered tolerable, this feasibility run-in will be followed by a randomized phase II portion studying giving vincristine sulfate together with topotecan hydrochloride, and cyclophosphamide to see how well it works compared with giving vincristine sulfate together with topotecan hydrochloride, cyclophosphamide, and bevacizumab in treating young patients with refractory or first recurrent extracranial Ewing's sarcoma. Drugs used in chemotherapy, such as vincristine sulfate, topotecan hydrochloride, 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 tumor growth by blocking blood flow to the tumor. Giving combination chemotherapy together with bevacizumab may kill more tumor cells.

Key Dates

First listed
Aug 15, 2007
Start date
Feb 29, 2008
Status verified
Jul 2014
Primary completion
Aug 31, 2009
Completion
Jan 31, 2010

Study Design

Enrollment
7 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm I (Feasibility assessment of VTCB)
    Patients receive bevacizumab IV over 30-90 minutes on day 1, vincristine sulfate IV on days 1, 8, and 15, and topotecan hydrochloride IV over 30 minutes and cyclophosphamide IV over 60 minutes on days 1-5. Treatment repeats every 21 days (except during weeks 14, 15 \[course 5\], 17, 18 \[course 6\], 26, 27 \[course 9\], 29, and 30 \[course 10\] when no chemotherapy is given) for up to 12 courses in the absence of disease progression or unacceptable toxicity.
  • Experimental: Arm II (VTCB)
    Patients receive bevacizumab, vincristine sulfate, topotecan hydrochloride, and cyclophosphamide as in Arm I.
  • Active Comparator: Arm III (CTC)
    Patients receive vincristine, topotecan hydrochloride, and cyclophosphamide as in arm I.

Primary Outcome Measure

The Occurrence of Limiting Toxicity in an Eligible and Evaluable Patient. [ Time Frame: First 2 courses (42 days) of therapy ]

Locations (1)

FacilityCityStateZIPSite coordinators
Children's Oncology GroupPhiladelphiaPennsylvania19104-

Find similar trials in Philadelphia, PA

By research site
Children's Oncology Group· Philadelphia, PA

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