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

Completed · Phase 2

Conditions studied: Ewing Sarcoma of Bone, Extraosseous Ewing Sarcoma, Peripheral Primitive Neuroectodermal Tumor, Recurrent Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor

In brief

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 facts

Study ID: NCT00516295
Run by: National Cancer Institute (NCI)
People needed: 7
Starts: 2008-02-01
Expected to finish: 2010-01-01
Last updated by the study team: 2014-09-02

Who can join

Age: 1 and older, up to 29. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

ALT =< 5 times ULN for age
Urine protein: creatinine ratio =< 0.5 OR 24-hour urine protein < 1,000 mg
At least 6 weeks since other prior substantial bone marrow radiation
At least 28 days since prior major surgical procedures (e.g., resection of tumor, laparotomy, thoracotomy, or open biopsy)
At least 2 weeks since prior myelosuppressive chemotherapy (4 weeks for nitrosoureas)
At least 2 weeks since prior local palliative radiotherapy (e.g., small port)
Diagnosis of extracranial Ewing sarcoma or primitive neuroectodermal tumor of bone or soft tissue meeting 1 of the following criteria: I) a first recurrence of localized disease; II) a first recurrence of initially metastatic disease; III) disease refractory to initial conventional therapy
Patients must have RECIST-measurable disease documented by clinical, radiographic, or histological criteria
Patients who do not have measurable disease (e.g., bone scan-determined metastatic disease only) remain eligible for the study and will be evaluable for disease-free progression
Karnofsky performance status (PS) 50-100% (> 16 years of age) OR Lansky PS 50-100% (=< 16 years of age )
Life expectancy >= 8 weeks
Absolute neutrophil count >= 1,000/μL
NOTE: Patients with tumor metastatic to bone marrow are permitted to receive transfusions to maintain hemoglobin and platelet counts. These patients will not be evaluable for hematologic toxicity. Patients who are refractory to platelet infusions (i.e., unable to maintain platelet counts > 75,000/μL) and have marrow involvement and platelet counts < 75,000/μL are not eligible
Fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy
At least 1 week since prior therapy with a biologic agent or growth factor
Patients must have histological verification of the malignancy at original diagnosis
Histological confirmation of relapse is highly recommended but not mandatory
Prior initial therapy with topotecan hydrochloride is allowed as long as > 2 years have elapsed since the initial diagnosis of Ewing sarcoma
Prior therapy with cyclophosphamide or vincristine is allowed
Minor surgical procedures (e.g., biopsies) for limited purposes of tissue retrieval allowed
Minor procedures include indwelling IV catheter placement and needle biopsy for diagnostic purposes
For minor surgeries, patients should not receive the first planned dose of bevacizumab until the wound is healed and 7 days have elapsed
At least 6 months since prior craniospinal radiotherapy or radiotherapy to >= 50% of the pelvis
At least 3 months since prior autologous stem cell transplantation (SCT)
Platelet count >= 75,000/μL (transfusion independent)

You may not qualify if…

Radiological or clinical evidence for parenchymal brain metastases or neuro axis involvement
Documented, chronic nonhealing wound, ulcer, or significant traumatic injury (those with bone fractures, including pathological fractures, or requiring surgical intervention) within the past 28 days
Other bone complications
Deep venous thrombosis (including pulmonary embolism) within the past 3 months
Recent (i.e., within 6 months) arterial thromboembolic events, including transient ischemic attack or cerebrovascular accident
History of myocardial infarction, severe or unstable angina, or peripheral vascular disease Prior bevacizumab
Radiotherapy or surgery for local control of recurrent disease concurrently with bevacizumab (bevacizumab must be held if radiotherapy or surgery is required)
Radiotherapy to localized painful lesions is allowed, provided >= 1 measurable lesion is not irradiated
Radiotherapy for local metastatic tumor control allowed after the first 2 courses of therapy
Other cancer chemotherapy or immunomodulating agents
Steroid use is allowed
Prior allogeneic SCT

Where it is running

Children's Oncology Group — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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