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