- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00002595
Toremifene in Treating Patients With Desmoid Tumors
PHASE II STUDY OF THE SAFETY AND EFFICACY OF TOREMIFENE IN THE THERAPY OF DESMOID TUMORS
RATIONALE: Estrogen can stimulate the growth of cancer cells. Hormone therapy using toremifene may fight the growth of desmoid tumors by reducing the production of estrogen.
PURPOSE: Phase II trial to study the effectiveness of toremifene in treating patients with desmoid tumors.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Illinois
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Park Ridge, Illinois, United States, 60068
- Lutheran General Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
Collaborators and Investigators
Investigators
- Study Chair: Brian L. Samuels, MD, Advocate Lutheran General Hospital
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neoplasms, Connective and Soft Tissue
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms, Connective Tissue
- Neoplasms, Fibrous Tissue
- Fibroma
- Fibromatosis, Aggressive
- Physiological Effects of Drugs
- Antineoplastic Agents
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Hormone Antagonists
- Bone Density Conservation Agents
- Selective Estrogen Receptor Modulators
- Estrogen Receptor Modulators
- Toremifene
Other Study ID Numbers
- LGH-1011
- CDR0000063797 (Registry Identifier: PDQ (Physician Data Query))
- NCI-V91-0211
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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