NCT00978146

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 or chemotherapy for this difficult to treat tumor.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Oct 2009

Longer than P75 for phase_2

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 15, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 16, 2009

Completed
15 days until next milestone

Study Start

First participant enrolled

October 1, 2009

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
Last Updated

April 20, 2017

Status Verified

April 1, 2017

Enrollment Period

5.3 years

First QC Date

September 15, 2009

Last Update Submit

April 19, 2017

Conditions

Desmoid TumorsFibromatosis

Outcome Measures

Primary Outcomes (1)

  • The primary outcome of this study is change in tumor size.

    1 year

Study Arms (1)

Desmoid tumor

EXPERIMENTAL

Patients with desmoid tumors

Drug: Hydroxyurea

Interventions

HydroxyureaDRUG

Patients will take oral hydroxyurea with a starting dose of 20 mg/kg daily. Patients will remain on hydroxyurea as long as there is a response or stability in tumor size and associated toxicities are manageable. Maximum treatment duration will be one year.

Desmoid tumor

Eligibility Criteria

AgeUp to 21 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Desmoid TumorsFibroma

Interventions

Hydroxyurea

Condition Hierarchy (Ancestors)

Neoplasms, Fibrous TissueNeoplasms, Connective TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasms

Intervention Hierarchy (Ancestors)

UreaAmidesOrganic Chemicals

Study Officials

  • Richard B Womer, M.D.

    Children's Hospital of Philadelphia

    STUDY CHAIR
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 15, 2009

First Posted

September 16, 2009

Study Start

October 1, 2009

Primary Completion

January 1, 2015

Study Completion

January 1, 2015

Last Updated

April 20, 2017

Record last verified: 2017-04