Celecoxib and Radiation Therapy in Treating Patients With Stage II or Stage III Soft Tissue Sarcoma of the Arm, Hand, Leg, or Foot That Has Been Removed by Surgery

Study Overview
=================
Brief Summary
-----------------
RATIONALE: Celecoxib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving celecoxib together with radiation therapy after surgery may kill any tumor cells that remain after surgery. PURPOSE: This phase I trial is studying the side effects and best dose of celecoxib when given together with radiation therapy in treating patients with stage II or stage III soft tissue sarcoma of the arm, hand, leg, or foot that has been removed by surgery.

Detailed Description
-----------------
OBJECTIVES: Determine the maximum tolerated dose of adjuvant celecoxib administered with radiotherapy in patients with resected stage II or III soft tissue sarcoma of the extremity. OUTLINE: This is a dose-escalation study of celecoxib. Beginning within 10 weeks of the most recent resection, patients undergo standard radiotherapy once daily, 5 days a week, in weeks 1-7. Patients also receive oral celecoxib twice daily in weeks 1-7 in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of celecoxib until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 6 patients experience dose-limiting toxicity. A maximum of 6 patients are treated at the MTD. After completion of study treatment, patients are followed periodically. PROJECTED ACCRUAL: A total of 24 patients will be accrued for this study.

Official Title
-----------------
A Phase I Trial of Postoperative Radiation With Dose-Escalation of A Cox-2 Inhibitor, Celebrex™ (CELECOXIB) in Patients With Soft Tissue Sarcoma of the Extremity

Conditions
-----------------
Childhood Malignant Fibrous Histiocytoma of Bone, Sarcoma

Intervention / Treatment
-----------------
* Drug: celecoxib
* Procedure: adjuvant therapy
* Radiation: radiation therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
DISEASE CHARACTERISTICS: Histologically confirmed soft tissue sarcoma of the extremity, including the following disease types: Liposarcoma Leiomyosarcoma Synovial cell sarcoma Malignant fibrous histiocytoma Spindle cell sarcoma Fibrosarcoma Chondrosarcoma Angiosarcoma Hemangiopericytoma Neurofibrosarcoma The following disease types are excluded: Kaposi's sarcoma Rhabdomyosarcoma Dermatofibrosarcoma Epithelioid cell sarcoma Ewing's sarcoma Osteosarcoma Intermediate- or high-grade tumor ≥ 5.0 cm in 1 dimension (stage II or III disease) Locally resected disease One prior wide local excision of the sarcoma in the same location of the extremity within the past 6 months allowed Prior neoadjuvant chemotherapy (of ≤ 3 courses), followed by a limb-sparing surgical resection of sarcoma found to have < 90% pathological tumor necrosis allowed Prior resection of an extremity mass that is subsequently found to be a sarcoma meeting study criteria, followed by ≤ 3 courses of chemotherapy (independent of the percentage of pathological tumor necrosis) allowed No evidence of nodal or distant metastases PATIENT CHARACTERISTICS: Karnofsky performance status 70-100% WBC ≥ 3,000/mm³ Absolute granulocyte count ≥ 1,500/mm³ Platelet count ≥ 100,000/mm³ Bilirubin ≤ 1.5 mg/dL SGPT and SGOT ≤ 2.5 times upper limit of normal (ULN) Creatinine ≤ 1.5 times ULN Calcium ≤ 1.3 times ULN No prior malignancy except cutaneous nonmelanomatous skin cancer, carcinoma in situ of the cervix, or other cancer for which the patient has been disease-free for at least 5 years No history of allergic reaction to sulfonamides or NSAIDs No known hypersensitivity to celecoxib or any component of its formulation No known HIV positivity No known coronary artery disease No cardiac event of any kind within the past 6 months No concurrent unstable cardiac status Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: See Disease Characteristics No prior radiotherapy to the extremity requiring radiation for this study No prior systemic chemotherapy for a malignant tumor No concurrent dilantin or lithium carbonate No other concurrent prescription or over-the-counter nonsteroidal anti-inflammatory agents (NSAIDs)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 120 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single Arm<br> | Drug: celecoxib<br> <br> Procedure: adjuvant therapy<br> <br> Radiation: radiation therapy<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Local failure |  | 3 years | 
| Regional relapse |  | 3 years | 
| Distant failure |  | 3 years | 
| Overall survival |  | 3 years | 
| Progression-free survival |  | 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
chondrosarcoma, adult angiosarcoma, adult fibrosarcoma, adult leiomyosarcoma, adult liposarcoma, adult neurofibrosarcoma, adult synovial sarcoma, childhood angiosarcoma, childhood fibrosarcoma, childhood leiomyosarcoma, childhood liposarcoma, childhood neurofibrosarcoma, childhood synovial sarcoma, nonmetastatic childhood soft tissue sarcoma, stage II adult soft tissue sarcoma, stage III adult soft tissue sarcoma, adult malignant fibrous histiocytoma, adult malignant hemangiopericytoma, childhood malignant hemangiopericytoma, localized childhood malignant fibrous histiocytoma of bone