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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

Primary Purpose

Childhood Malignant Fibrous Histiocytoma of Bone, Sarcoma

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
celecoxib
adjuvant therapy
radiation therapy
Sponsored by
University of Miami
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Childhood Malignant Fibrous Histiocytoma of Bone focused on measuring 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

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • University of Miami Sylvester Comprehensive Cancer Center - Miami

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Single Arm

Arm Description

Outcomes

Primary Outcome Measures

Local failure
Regional relapse
Distant failure
Overall survival
Progression-free survival

Secondary Outcome Measures

Full Information

First Posted
March 20, 2007
Last Updated
December 14, 2016
Sponsor
University of Miami
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1. Study Identification

Unique Protocol Identification Number
NCT00450736
Brief Title
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
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2016
Overall Recruitment Status
Completed
Study Start Date
March 2004 (undefined)
Primary Completion Date
May 2009 (Actual)
Study Completion Date
May 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Miami

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
3 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Single Arm
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
celecoxib
Intervention Type
Procedure
Intervention Name(s)
adjuvant therapy
Intervention Type
Radiation
Intervention Name(s)
radiation therapy
Primary Outcome Measure Information:
Title
Local failure
Time Frame
3 years
Title
Regional relapse
Time Frame
3 years
Title
Distant failure
Time Frame
3 years
Title
Overall survival
Time Frame
3 years
Title
Progression-free survival
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aaron H. Wolfson, MD
Organizational Affiliation
University of Miami Sylvester Comprehensive Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
University of Miami Sylvester Comprehensive Cancer Center - Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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