Sulindac and Tamoxifen in Treating Patients With Desmoid Tumor
Completed · Phase 2
Conditions studied: Desmoid Tumor
In brief
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.
Key facts
- Study ID
- NCT00068419
- Run by
- Children's Oncology Group
- People needed
- 70
- Starts
- 2004-02-01
- Expected to finish
- 2010-04-26
- Last updated by the study team
- 2020-02-19
Who can join
Age: any, up to 18. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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)
Where it is running
- Children's Oncology Group — Monrovia, California, United States
Full record on ClinicalTrials.gov
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