A Trial of Imatinib for Patients With Aggressive Desmoid Tumor (Aggressive Fibromatosis)

Fibromatosis Clinical Trial

Official title:

A Phase II Trial of Imatinib for Patients With Aggressive Desmoid Tumor (Aggressive Fibromatosis)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02495519
• Other study ID #: 4-2014-0074
• Status: Completed
• Phase: Phase 2
• Start date: April 2014
• Est. completion date: June 2018

Study information

• Verified date: January 2020
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Aggressive fibromatosis (AF, also known as desmoid tumor) is a fibroproliferative neoplasm that typically arises in the abdomen but can develop at other anatomic sites, most commonly in the extremities. These tumors have a relatively high local failure rate after primary treatment using surgery and/or radiotherapy, and although rarely giving rise to distant metastases, can be multifocal and, therefore, not surgically resectable. Moreover, tumor may recur adjacent to the site of surgical resection, underscoring the limitations of surgery in the palliative setting. Therefore, effective medical therapies for AF are needed to maintain quality of life and prolong survival.The goal of the current study was to better define the activity of imatinib in the treatment of AF and to determine the molecular basis for response/nonresponse

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: June 2018
• Est. primary completion date: June 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years and older

Eligibility

Inclusion Criteria:

1. Written consent;

2. Age = 10 years;

3. Eastern Cooperative Oncology Group Performance status = 2;

4. Histologically confirmed desmoid tumor;

5. Disease progression after local treatment

6. Measurable target lesion (RECIST criteria) ;

7. Adequate hematological, renal and liver functions :

Exclusion Criteria:

1. Other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ.

2. Pregnant or lactating female

3. Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the patient to participate in the study

Related Conditions & MeSH terms

• Aggression
• Fibroma
• Fibromatosis

Intervention

Drug:
• Imatinib
Imatinib 400 mg/day until disease progression

Locations

Country	Name	City	State
Korea, Republic of	Severance Hospital, Yonsei University Health System	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	non-progressive rate	non-progressive rate at 16weeks	16weeks
Secondary	overall survival		16 weeks