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Effect of Hydroxyurea as Treatment for Primary Desmoid Tumors

This study has been withdrawn prior to enrollment.
(Study was administratively withdrawn by the IRB; no subjects were enrolled)
Sponsor:
Information provided by (Responsible Party):
Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier:
NCT00978146
First received: September 15, 2009
Last updated: April 19, 2017
Last verified: April 2017
September 15, 2009
April 19, 2017
October 2009
January 2015   (Final data collection date for primary outcome measure)
The primary outcome of this study is change in tumor size. [ Time Frame: 1 year ]
Same as current
Complete list of historical versions of study NCT00978146 on ClinicalTrials.gov Archive Site
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Effect of Hydroxyurea as Treatment for Primary Desmoid Tumors
Effect of Hydroxyurea as Treatment for Primary Desmoid Tumors in Adults and Children (CHP-914)
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.

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 good tumor control, but at the expense of significant side effects along with a high risk of local recurrence after surgical excision. Low dose regimens of standard chemotherapy drugs have been favored as a conservative first-line treatment; however, refractory and recurrent tumors are not uncommon. The purpose of this study is to investigate the efficacy and safety of using hydroxyurea, an anti-neoplastic agent with relatively few side-effects, as a novel treatment for primary, unresectable desmoid tumors, desmoid tumors that have had an incomplete primary resection, or desmoid tumors that have recurred after other therapy.

Patients presenting to our oncology center with a new diagnosis of desmoid tumor, or a recurrent desmoid tumor, will be eligible for this study. After informed consent, physical examination, and baseline imaging studies (CT/MRI), patients will receive oral hydroxyurea at a starting dose of 20 mg/kg daily. Laboratory tests will be performed at set intervals to maintain the appropriate dose and monitor for cytopenias. Clinical evaluations, physical examinations, and/or imaging studies will be conducted every three months to assess for changes in tumor size. Patients will remain on hydroxyurea as long as there is a response or stability in tumor size and associated toxicities are manageable. Data will be collected regarding the response to the drug, the duration of the response, and the occurrence of adverse events. The goal of the analysis will be to determine the efficacy of hydroxyurea as a treatment modality for desmoid tumors.

Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
  • Desmoid Tumors
  • Fibromatosis
Drug: Hydroxyurea
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.
Experimental: Desmoid tumor
Patients with desmoid tumors
Intervention: Drug: Hydroxyurea
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
January 2015
January 2015   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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 Criteria:

  • 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
Sexes Eligible for Study: All
up to 21 Years   (Child, Adult)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
United States
 
NCT00978146
09-007317
Yes
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Children's Hospital of Philadelphia
Children's Hospital of Philadelphia
Not Provided
Study Chair: Richard B Womer, M.D. Children's Hospital of Philadelphia
Children's Hospital of Philadelphia
April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP