Skip Navigation
 
 
 
 
 
Print This Page
Share this page: More
 

Search Results

Title:
A Phase III Randomized Trial of Adding Vincristine-topotecan-cyclophosphamide to Standard Chemotherapy in Initial Treatment of Non-metastatic Ewing Sarcoma
Protocol Number:
PAEWS1031
Phase:
Phase III
Physician:
David Loeb
Purpose:
This randomized phase III trial is studying combination chemotherapy in treating patients with non-metastatic extracranial Ewing sarcoma.
Eligibility:
Ages Eligible for Study: up to 50 Years Genders Eligible for Study: Both Accepts Healthy Volunteers: No CriteriaDISEASE CHARACTERISTICS:Newly diagnosed extracranial, non-metastatic Ewing sarcoma or primitive neuroectodermal tumors of bone or soft tissueFor the purpose of this study, any of the following are considered localized disease:Chest wall tumors with ipsilateral pleural effusions Ipsilateral positive pleural fluid cytology Ipsilateral pleural-based secondary tumor nodules Regional node involvement, based on clinical suspicion confirmed by pathologic documentation, are considered to be non-metastatic disease Tumors arising in the bony skull (extra-dural) are considered to be extracranial No evidence of metastatic disease, including the following:Lesions that are discontinuous from the primary tumor, are not regional lymph nodes, and do not share a body cavity with the primary tumor Contralateral pleural effusion and contralateral pleural nodules Distant lymph node involvement Pulmonary nodules that meet the following criteria:Solitary nodule greater than 0.5 cm or multiple nodules of greater than 0.3 cm unless biopsied and negative for Ewing sarcoma Biopsies of solitary nodule less than 0.5 cm or multiple nodules less than 3.0 cm (are not required but if performed) positive for metastatic disease No tumors arising in the intra-dural soft tissue PATIENT CHARACTERISTICS:Creatinine clearance or radioisotope GFR �?� 70 mL/min OR serum creatinine based on age and/or gender as follows:0.4 mg/dL (1 month to less than 6 months of age) 0.5 mg/dL (6 months to less than 1 year of age) 0.6 mg/dL (1 year to less than 2 years of age) 0.8 mg/dL (2 years to less than 6 years of age) 1.0 mg/dL (6 years to less than 10 years of age) 1.2 mg/dL (10 years to less than 13 years of age) 1.5 mg/dL (male) or 1.4 mg/dL (female) (13 years to less than 16 years of age) 1.7 mg/dL (male) or 1.4 mg/dL (female) (�?� 16 years of age) Total bilirubin less than 1.5 times upper limit of normal (ULN) AST or ALT less than 2.5 times ULN Shortening fraction of �?� 27% by echocardiogram OR ejection fraction �?� 50% by radionuclide angiogram Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception for the duration of study treatment PRIOR CONCURRENT THERAPY:No prior chemotherapy or radiotherapy Prior biopsy of the primary tumor without an attempt at complete or partial resection allowedPatients are still allowed if unplanned excision was attempted or accomplished as long as adequate imaging was obtained prior to surgery No other concurrent chemotherapy or immunomodulating agents (including steroids unless used as an antiemetic) No concurrent sargramostim (GM-CSF)
Treatment:
Arm I: Experimental Patients receive induction therapy comprising vincristine sulfate IV on day 1 in weeks 1, 2, 5, 6, 9, and 10; doxorubicin hydrochloride IV on days 1 and 2 and cyclophosphamide IV over 30-60 minutes on day 1 in weeks 1, 5, and 9; and ifosfamide IV over 1 hour and etoposide IV over 1-2 hours on days 1-5 in weeks 3, 7, and 11. Patients then receive consolidation therapy comprising vincristine sulfate on day 1 in weeks 1, 2, 7, 8, 9, 10, 13, 14, 17, 18, 21, and 22; doxorubicin hydrochloride IV on days 1 and 2 in weeks 1 and 9; cyclophosphamide IV over 30-60 minutes on day 1 in weeks 1, 7, 9, 13, 17, and 21; and ifosfamide IV over 1 hour and etoposide IV over 1-2 hours on days 1-5 in weeks 3, 5, 11, 15, and 19.Interventions:Drug: cyclophosphamide Drug: doxorubicin hydrochloride Drug: etoposide Drug: ifosfamide Drug: vincristine sulfate Arm II: Experimental Patients receive induction therapy comprising vincristine sulfate IV on day 1 in weeks 1, 2, 5, 6, 9, 10, 11 and 12; topotecan hydrochloride IV over 30 minutes on days 1-5 in weeks 1 and 9; cyclophosphamide IV over 15-60 minutes on days 1-5 in weeks 1 and 9, and on day 1 of weeks 5 and 11; ifosfamide and etoposide as in arm I; and doxorubicin hydrochloride IV on days 1 and 2 in weeks 5 and 11. Patients then receive consolidation therapy comprising vincristine sulfate IV on day 1 in weeks 1, 2, 7-10, 13-16, 19, and 20; topotecan hydrochloride IV over 30 minutes on days 1-5 in weeks 1, 7, and 15; cyclophosphamide IV over 15-60 minutes on days 1-5 in weeks 1, 7, and 15, and on day 1 in weeks 9, 13, and 19; ifosfamide IV over 1 hour and etoposide IV over 1-2 hours on days 1-5 in weeks 3, 5, 11, 17, and 21; and doxorubicin hydrochloride IV on days 1 and 2 in weeks 9, 13, and 19.Interventions:Drug: cyclophosphamide Drug: doxorubicin hydrochloride Drug: etoposide Drug: ifosfamide Drug: topotecan hydrochloride Drug: vincristine sulfate
Population:
Pediatric
Last Update
11/26/2014 04:10 AM
 

Read Our Blogs
Cancer Matters: timely topics
Our Cancer: for caregivers

 

Cancer Dictionary

NCI Dictionary of Cancer Terms, a resource with more than 6,000 terms related to cancer and medicine.

Traveling for care?

blue suitcase

Whether crossing the country or the globe, we make it easy to access world-class care at Johns Hopkins.

Maryland 410-955-5222
U.S. 410-955-5222
International +1-410-614-6424

NCI CCC

 
 
 
 
 

© The Johns Hopkins University, The Johns Hopkins Hospital, and Johns Hopkins Health System. All rights reserved.