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


Phase 2
16 Years
N/A
Not Enrolling
Both
Desmoid Tumor

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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.

Inclusion Criteria


DISEASE CHARACTERISTICS: Histologically proven primary or recurrent desmoid tumor
Unresectable and symptomatic or progressive disease OR Disease for which a mutilating
surgery would be required for complete resection Bidimensionally measurable or clinically
evaluable disease

PATIENT CHARACTERISTICS: Age: 16 and over (no prepubertal patients) Performance status:
0-2 Life expectancy: More than 2 months Hematopoietic: Absolute granulocyte count at least
1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 2 mg/dL
Transaminases no greater than 3 times upper limit of normal (ULN) Alkaline phosphatase no
greater than 3 times ULN Renal: Not specified Cardiovascular: No history of deep vein
thrombosis Other: Not pregnant Fertile patients must use effective barrier contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Not specified
Endocrine therapy: No concurrent dexamethasone for antiemesis No other concurrent hormonal
therapy, including hormonal contraceptives Radiotherapy: Not specified Surgery: See
Disease Characteristics

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Brian L. Samuels, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Lutheran General Hospital

Authority:

United States: Federal Government

Study ID:

LGH-1011

NCT ID:

NCT00002595

Start Date:

July 1991

Completion Date:

September 2010

Related Keywords:

  • Desmoid Tumor
  • desmoid tumor
  • Fibromatosis, Aggressive

Name

Location

Lutheran General HospitalPark Ridge, Illinois  60068