|
|
|
|
|
|
Sponsors and Collaborators: |
Children's Oncology Group National Cancer Institute (NCI) |
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00516295 |
RATIONALE: Drugs used in chemotherapy, such as vincristine, topotecan, 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.
PURPOSE: This randomized phase II trial is studying giving vincristine together with topotecan, and cyclophosphamide to see how well it works compared with giving vincristine together with topotecan, cyclophosphamide, and bevacizumab in treating young patients with refractory or first recurrent extracranial Ewing's sarcoma.
Condition | Intervention | Phase |
Sarcoma |
Drug: bevacizumab Drug: cyclophosphamide Drug: topotecan hydrochloride Drug: vincristine sulfate |
Phase II |
MedlinePlus related topics: | Cancer Soft Tissue Sarcoma |
ChemIDplus related topics: | Cyclophosphamide Vincristine sulfate Vincristine Topotecan hydrochloride Topotecan Bevacizumab |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label |
Official Title: | A Randomized Phase II Study of Bevacizumab (NSC 704865, BB-IND# 7921) Combined With Vincristine, Topotecan and Cyclophosphamide in Patients With First Recurrent Ewing Sarcoma |
Estimated Enrollment: | 78 |
Study Start Date: | February 2008 |
Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
Arm I (VTCB): Experimental
Patients receive bevacizumab IV over 30-90 minutes on day 1, vincristine 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.
|
Drug: bevacizumab
Given IV
Drug: cyclophosphamide
Given IV
Drug: topotecan hydrochloride
Given IV
Drug: vincristine sulfate
Given IV
|
Arm II (VTC): Active Comparator
Patients receive vincristine, topotecan hydrochloride, and cyclophosphamide as in arm I.
|
Drug: cyclophosphamide
Given IV
Drug: topotecan hydrochloride
Given IV
Drug: vincristine sulfate
Given IV
|
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study. Patients are stratified according to time to disease recurrence (< 2 years vs ≥ 2 years).
After completion of study therapy, patients are followed periodically.
Ages Eligible for Study: | 1 Year to 29 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Inclusion criteria:
Diagnosis of extracranial Ewing sarcoma or primitive neuroectodermal tumor of bone or soft tissue meeting 1 of the following criteria:
Patients must have histological verification of the malignancy at original diagnosis
Patients must have RECIST-measurable disease documented by clinical, radiographic, or histological criteria
Exclusion criteria:
PATIENT CHARACTERISTICS:
Inclusion criteria:
Exclusion criteria:
PRIOR CONCURRENT THERAPY:
Inclusion criteria:
Minor surgical procedures (e.g., biopsies) for limited purposes of tissue retrieval allowed
Patients on full-dose anticoagulants (e.g., warfarin) with PT INR > 1.5 are eligible if both of these criteria are met:
Exclusion criteria:
Radiotherapy or surgery for local control of recurrent disease concurrently with bevacizumab (bevacizumab must be held if radiotherapy or surgery is required)
Other cancer chemotherapy or immunomodulating agents
Show 59 Study Locations |
Children's Oncology Group |
National Cancer Institute (NCI) |
Study Chair: | Patrick J. Leavey, MD | University of Texas Southwestern Medical Center at Dallas |
Clinical trial summary from the National Cancer Institute's PDQ® database 
  |
Study ID Numbers: | CDR0000560873, COG-AEWS0521 |
First Received: | August 14, 2007 |
Last Updated: | October 2, 2008 |
ClinicalTrials.gov Identifier: | NCT00516295 |
Health Authority: | United States: Food and Drug Administration |
|
|
|
|
|