Trial record 5 of 47 for:    "Malignant fibrous histiocytoma"

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Miami Sylvester Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00450736
First received: March 20, 2007
Last updated: August 13, 2013
Last verified: August 2013
  Purpose

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.


Condition Intervention Phase
Childhood Malignant Fibrous Histiocytoma of Bone
Sarcoma
Drug: celecoxib
Procedure: adjuvant therapy
Radiation: radiation therapy
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by University of Miami Sylvester Comprehensive Cancer Center:

Primary Outcome Measures:
  • Local failure [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Regional relapse [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Distant failure [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Progression-free survival [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Enrollment: 3
Study Start Date: March 2004
Study Completion Date: May 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Single Arm Drug: celecoxib Procedure: adjuvant therapy Radiation: radiation therapy

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00450736

Locations
United States, Florida
University of Miami Sylvester Comprehensive Cancer Center - Miami
Miami, Florida, United States, 33136
Sponsors and Collaborators
University of Miami Sylvester Comprehensive Cancer Center
Investigators
Study Chair: Aaron H. Wolfson, MD University of Miami Sylvester Comprehensive Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: University of Miami Sylvester Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00450736     History of Changes
Other Study ID Numbers: UMIAMI-20030283, SCCC-2003053, WIRB-20051240
Study First Received: March 20, 2007
Last Updated: August 13, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Miami Sylvester Comprehensive Cancer Center:
adult malignant fibrous histiocytoma
localized childhood malignant fibrous histiocytoma of bone
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 hemangiopericytoma
childhood malignant hemangiopericytoma

Additional relevant MeSH terms:
Histiocytoma
Fibrosis
Histiocytoma, Benign Fibrous
Histiocytoma, Malignant Fibrous
Sarcoma
Neoplasms, Fibrous Tissue
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Pathologic Processes
Celecoxib
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Therapeutic Uses
Central Nervous System Agents
Antirheumatic Agents

ClinicalTrials.gov processed this record on April 17, 2014