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

NCT00450736 | Completed Phase 1

• 3 other identifiers: 20030283SCCC-2003053WIRB-20051240
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

Childhood Malignant Fibrous Histiocytoma of Bone; Sarcoma

Keywords

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

Outcome Measures

Primary Outcomes (5)

• Local failure

  3 years

• Regional relapse

  3 years

• Distant failure

  3 years

• Overall survival

  3 years

• Progression-free survival

  3 years

Study Arms (1)

Single Arm

EXPERIMENTAL

Drug: celecoxib; Procedure: adjuvant therapy; Radiation: radiation therapy

Interventions

celecoxib DRUG

Single Arm

adjuvant therapy PROCEDURE

Single Arm

radiation therapy RADIATION

Single Arm

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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)

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of Miami: lead

Study Sites (1)

University of Miami Sylvester Comprehensive Cancer Center - Miami

Miami, Florida, 33136, United States

Location

MeSH Terms

Conditions

Sarcoma; Chondrosarcoma; Hemangiosarcoma; Fibrosarcoma; Leiomyosarcoma; Liposarcoma; Neurofibrosarcoma; Sarcoma, Synovial; Histiocytoma, Malignant Fibrous; Hemangiopericytoma, Malignant

Interventions

Celecoxib; Chemotherapy, Adjuvant; Radiotherapy

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Connective Tissue; Neoplasms, Vascular Tissue; Neoplasms, Fibrous Tissue; Neoplasms, Muscle Tissue; Neoplasms, Adipose Tissue; Neurofibroma; Nerve Sheath Neoplasms; Neoplasms, Nerve Tissue; Peripheral Nervous System Neoplasms; Nervous System Neoplasms; Nervous System Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases; Histiocytoma

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Combined Modality Therapy; Therapeutics; Drug Therapy

Study Officials

• Aaron H. Wolfson, MD

  University of Miami Sylvester Comprehensive Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2007
• First Posted: March 22, 2007
• Study Start: March 1, 2004
• Primary Completion: May 1, 2009
• Study Completion: May 1, 2009
• Last Updated: December 15, 2016

Record last verified: 2016-12

Locations

US (1)