Status:
COMPLETED
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
Lead Sponsor:
University of Miami
Conditions:
Childhood Malignant Fibrous Histiocytoma of Bone
Sarcoma
Eligibility:
All Genders
18-120 years
Phase:
PHASE1
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 kil...
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 ...
Eligibility Criteria
Inclusion
- 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)
Exclusion
Key Trial Info
Start Date :
March 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2009
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT00450736
Start Date
March 1 2004
End Date
May 1 2009
Last Update
December 15 2016
Active Locations (1)
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1
University of Miami Sylvester Comprehensive Cancer Center - Miami
Miami, Florida, United States, 33136