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

Yonsei University

Status and phase: Completed; Phase 2

Conditions: Fibromatosis

Treatments: Drug: Imatinib

Study type: Interventional

Funder types: Other

Identifiers

NCT02495519

4-2014-0074

Details and patient eligibility

About

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

Enrollment: 21 patients

Sex: All

Ages: 10+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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21 participants in 1 patient group

imatinib

Experimental group

Description:

Imatinib 400 mg/day until disease progression

Treatment:

Drug: Imatinib