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Cyclophosphamide, Doxorubicin, Vincristine w/ Irinotecan and Temozolomide in Ewings Sarcoma

NCT01313884 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2017-11-24

Study results available
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Summary

The outcome of patients with metastatic Ewings Sarcoma is poor with current standard of care chemotherapy, with less than 30% survival. Based on recent encouraging pediatric literature we have designed this trial to improve the outcome of patients with metastatic Ewings sarcoma using Irinotecan and Temozolomide in addition to standard chemotherapy.

Conditions

  • Bone Cancer
  • Ewing's Sarcoma

Interventions

DRUG

Irinotecan

50 mg/m2/day x 5 days

DRUG

Vincristine

2 mg/m2 to a maximum of 2 mg

DRUG

Temozolomide

100 mg/m2/day x 5 days followed by 2 weeks treatment-free

DRUG

Doxorubicin

Starting dose 75 mg/m2 to a maximum of 450mg/m2

DRUG

Cytoxan

1200 mg/m2

DRUG

Pegfilgrastim

6 mg subcutaneous within 24 to 48 hours after each Regimen A cycle

Sponsors & Collaborators

Principal Investigators

  • Kristen N. Ganjoo · Stanford University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
13 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-05-31
Primary Completion
2014-07-31
Completion
2014-07-31

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01313884 on ClinicalTrials.gov