Sulindac and Tamoxifen in Treating Patients With Desmoid Tumor

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