Status:

WITHDRAWN

Effect of Hydroxyurea as Treatment for Primary Desmoid Tumors

Lead Sponsor:

Children's Hospital of Philadelphia

Conditions:

Desmoid Tumors

Fibromatosis

Eligibility:

All Genders

Up to 21 years

Phase:

PHASE2

Brief Summary

The purpose of this study is to examine the response rate of desmoid tumors to hydroxyurea. The investigators hypothesize that hydroxyurea will be a safe, non-toxic alternative to aggressive surgery o...

Detailed Description

The treatment of desmoid tumors is complicated by benign histology and potentially aggressive and recurrent behavior. Invasive or intensive treatments with surgery or radiation therapy can lead to goo...

Eligibility Criteria

Inclusion

  • Patients \</= 21 years of age will be eligible
  • Histologically-confirmed diagnosis of desmoid tumor
  • Measurable disease
  • Stable hematologic, renal and hepatic parameters
  • Negative pregnancy test for women of childbearing potential

Exclusion

  • Presence of a second neoplastic process
  • Pregnant or breastfeeding women, fetuses, and prisoners will not be included in this study
  • Patients receiving additional treatment for tumor other than pain control
  • Patients having taken an investigational drug within the past 30 days

Key Trial Info

Start Date :

October 1 2009

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

January 1 2015

Estimated Enrollment :

Patients enrolled

Trial Details

Trial ID

NCT00978146

Start Date

October 1 2009

End Date

January 1 2015

Last Update

April 20 2017

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