Current Research: Pediatric Hematology-Oncology

ARST0321-- Sulindac and Tamoxifen 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.

This phase II trial is studying how well giving sulindac together with tamoxifen works in treating patients with desmoid tumor.

Eligibility

Patients may be eligible for this trial if:

• No greater than 18 years of age inclusive when originally diagnosed with desmoid tumor to be treated on this protocol.
• Patients must have biopsy-proven DT
• Patients must have measurable disease, documented by clinical and/or radiographic findings.
• Patients must have a Karnofsky performance status ≥ 50 for patients > 16 years of age, or Lansky performance status of m ≥ 50 for patients ≤ 16 years of age.
• Patients must have a life expectancy of ≥ 8 weeks.
• Patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study.

Exclusion Criteria:

• Patients with the following will be excluded:
  • History of peptic ulcer disease or significant gastrointestinal hemorrhage
  • History of deep venous thrombosis
  • Diagnosis of hemophilia, von Willebrand Disease, or other clinically significant bleeding diathesis.
  • Aspirin allergy
  • Pregnancy

Trial Sponsor

• Children’s Oncology Group (COG); National Cancer Institute (NCI)

Project Begin Date

• Sept 2005

Tentative Project End Date

• Oct 2009

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Revised March 30, 2009.   Please send comments, suggestions or questions about this page to Goldei Posey, gposey@mcg.edu .