Sulindac and Tamoxifen in Treating Patients With Desmoid Tumor
Condition: Desmoid Tumor
MeSH terms: Fibromatosis, Aggressive
Intervention: tamoxifen citrate; sulindac; laboratory biomarker analysis
Intervention description: Given orally; Given orally; Correlative studies
Intervention MeSH terms: Tamoxifen; Sulindac
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 70.0
Sex: All
Maximum age: 18 Years
Healthy volunteers: No

Summary:

      This phase II trial is studying how well giving sulindac together with tamoxifen works in
      treating patients with desmoid tumor. Sulindac may stop the growth of cancer cells by
      blocking the enzymes necessary for cancer cell growth. Hormone therapy using tamoxifen may
      fight cancer by blocking the use of estrogen. Combining sulindac with tamoxifen may kill more
      cancer cells.
    

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