RATIONALE: Hyperthermia therapy kills tumor cells by heating them to several degrees above body temperature. Using MRI to measure heat may help to determine the effectiveness of hyperthermia therapy. Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy, such as ifosfamide and doxorubicin, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining hyperthermia with radiation therapy and chemotherapy before surgery may kill more tumor cells and shrink the tumor so that it can be removed.

PURPOSE: This phase I/II trial is studying the side effects of hyperthermia when given together with radiation therapy and optional chemotherapy and to see how well they work in treating patients who are undergoing surgery for soft tissue sarcoma of the limbs.

Condition	Treatment or Intervention	Phase
stage I adult soft tissue sarcoma stage II adult soft tissue sarcoma stage III adult soft tissue sarcoma stage IV adult soft tissue sarcoma	Drug: doxorubicin  Drug: ifosfamide  Procedure: adjuvant therapy  Procedure: chemotherapy  Procedure: conventional surgery  Procedure: high-dose chemotherapy  Procedure: hyperthermia  Procedure: neoadjuvant therapy  Procedure: radiation therapy  Procedure: surgery	Phase I Phase II

Further Study Details: 

OBJECTIVES: Primary

• Determine the feasability and accuracy of real time magnetic resonance-based non-invasive thermometry in patients with grade 2 or 3 soft tissue sarcoma of the extremity receiving combination hyperthermia, radiotherapy, surgery, and optional high-dose ifosfamide and doxorubicin.

Secondary

• Determine the local control, disease-free survival, and overall survival of patients treated with this regimen.
• Determine acute and late toxic effects of this regimen in these patients.
• Correlate measurements of tumor physiology, defined by gadolinium-enhanced magnetic resonance imaging, magnetic resonance spectroscopy, and tumor oxygenation, with clinical and/or pathological response and/or metastatic potential in patients treated with this regimen.

OUTLINE: Patients may receive high-dose ifosfamide IV continuously over 6 days (144 hours). Beginning 3 weeks after the completion of ifosfamide, patients undergo radiotherapy once daily, 5 days a week, for 5 weeks. Beginning 1 hour after radiotherapy, patients also undergo hyperthermia (with heat measured by conventional and magnetic resonance-based thermometry) over 1-2 hours once weekly for 5 weeks. Approximately 4 weeks after the completion of radiotherapy and hyperthermia, patients undergo surgery. Approximately 1 month after surgery, patients may then receive high-dose doxorubicin IV once every 4 weeks for 4 courses.

PROJECTED ACCRUAL: A total of 10-30 patients will be accrued for this study within 2-6 years.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed grade 2 or 3 soft tissue sarcoma
• No specific tumor size limitation, but the involved extremity must fit within the hyperthermia applicator

PATIENT CHARACTERISTICS: Age

• 18 and over

Performance status

• Karnofsky 70-100%

Life expectancy

• At least 6 months

Hematopoietic

• Not specified

Hepatic

• Not specified

Renal

• Not specified

Cardiovascular

• Cardiac function ≥ 45% at rest by MUGA
• No cardiac pacemakers or implanted defibrillators that are not treatable by ultrasound or microwave technology

Other

• No implanted metal (e.g. orthopedic rods, surgical clips, bullets or shrapnel)
• Not pregnant
• Negative pregnancy test
• Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy

• Not specified

Chemotherapy

• Not specified

Endocrine therapy

• Not specified

Radiotherapy

• Not specified

Surgery

• Not specified

North Carolina
      Duke Comprehensive Cancer Center, North Carolina,  27710,  United States; Recruiting

Study chairs or principal investigators

Ellen L. Jones, MD, PhD,  Principal Investigator,  Duke Comprehensive Cancer Center   

Study ID Numbers:  CDR0000388048; DUMC-1308-04-7R5; DUMC-G040102; DUMC-G880018; NCT00093509
Record last reviewed:  September 2004
Last Updated:  February 24, 2005
Record first received:  October 6, 2004
ClinicalTrials.gov Identifier:  NCT00093509
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08