Sulindac and Tamoxifen in Treating Patients With Desmoid Tumor
Desmoid Tumor
About this trial
This is an interventional treatment trial for Desmoid Tumor
Eligibility Criteria
Inclusion Criteria: Histologically confirmed desmoid tumor, meeting 1 of the following criteria: Newly diagnosed disease Not previously treated Not amenable to complete surgical resection and/or radiotherapy If surgical resection was attempted, there must be gross residual disease measurable by MRI Radiographically documented recurrent or progressive disease No prior chemotherapy or radiotherapy for the present recurrence Tumors that progressed on prior chemotherapy are allowed provided patients have not received chemotherapy for this recurrence Measurable disease by gadolinium-enhanced MRI No other fibroblastic lesions or fibromatoses Lipofibromatosis or desmoplastic fibroma of the bone allowed Performance status - Karnofsky Score 50-100% (patients over age 16) Performance status - Lansky Score 50-100% (patients age 16 and under) At least 8 weeks Absolute neutrophil count at least 1,000/mm^3 Platelet count at least 100,000/mm^3 (transfusion independent) Hemoglobin at least 10.0 g/dL (transfusion allowed) No hemophilia No von Willebrand disease No other clinically significant bleeding diathesis Bilirubin no greater than 1.5 times upper limit of normal (ULN) Alanine aminotransferase (ALT) less than 2.5 times ULN Creatinine adjusted according to age as follows: No greater than 0.4 mg/dL (≤ 5 months) No greater than 0.5 mg/dL (6 months -11 months) No greater than 0.6 mg/dL (1 year-23 months) No greater than 0.8 mg/dL (2 years-5 years) No greater than 1.0 mg/dL (6 years-9 years) No greater than 1.2 mg/dL (10 years-12 years) No greater than 1.4 mg/dL (13 years and over [female]) No greater than 1.5 mg/dL (13 years to 15 years [male]) No greater than 1.7 mg/dL (16 years and over [male]) Creatinine clearance or radioisotope glomerular filtration rate at least 70 mL/min No prior deep venous thrombosis Electrocardiogram (EKG) normal Chest x-ray normal No prior significant gastrointestinal hemorrhage No prior peptic ulcer disease Not pregnant or nursing Fertile patients must use effective nonhormonal contraception No evidence of active graft-versus-host disease No allergy to aspirin Recovered from prior immunotherapy At least 7 days since prior anticancer biologic agents At least 6 months since prior allogeneic stem cell transplantation More than 1 week since prior growth factors No concurrent immunomodulating agents No prior nonsteroidal anti-inflammatory drugs (NSAIDs) for desmoid tumor More than 2 weeks since prior myelosuppressive chemotherapy (4 weeks for nitrosoureas) and recovered No concurrent anticancer chemotherapy No prior estrogen antagonists for desmoid tumor No concurrent hormonal contraceptives No concurrent steroids except for non tumor indications (e.g., asthma or severe allergic reactions) No concurrent NSAIDs for desmoid tumor Occasional NSAIDs for musculoskeletal or other pain are allowed Recovered from prior radiotherapy No concurrent adjuvant radiotherapy No concurrent participation in another COG therapeutic study
Sites / Locations
- Children's Oncology Group
Arms of the Study
Arm 1
Experimental
Treatment (enzyme inhibitor therapy, anti-estrogen therapy)
Patients receive oral sulindac and oral tamoxifen citrate twice daily for up to 12 months (four 3-month courses) in the absence of disease progression or unacceptable toxicity. Patients who achieve a complete response (CR) receive 1 additional month of treatment beyond documentation of CR.