Trial Information

PHASE II STUDY OF THE SAFETY AND EFFICACY OF TOREMIFENE IN THE THERAPY OF DESMOID TUMORS

OBJECTIVES: I. Determine the efficacy of toremifene in terms of tumor response rate and
symptom relief in patients with desmoid tumors. II. Determine the safety of this regimen in
these patients. III. Determine the quality of life of patients treated with this regimen.

OUTLINE: Patients are stratified by gender. Patients receive oral toremifene daily until
complete or maximal response in the absence of disease progression or unacceptable toxicity.
Patients achieving maximal response undergo complete resection of all lesions, if feasible.
Nonsurgical candidates with severe or life-threatening disease not achieving partial or
complete response or symptom relief at 12 months may continue on toremifene at the
discretion of the study chairperson. Patients with stable disease who do not undergo surgery
may continue on toremifene for a maximum of 12 months at the discretion of the treating
physician. Patients who continue to experience symptom relief at 12 months may continue on
toremifene at the discretion of the study chairperson. Quality of life is assessed at
baseline and at 2 and 6 months. Patients are followed every 8 weeks for 4 years and then
annually thereafter.

PROJECTED ACCRUAL: A total of 24-72 (12-36 per stratum) will be accrued for this study.