Clinical trial NCT00093509: MRI Sarcoma Non Invasive Thermometry
Official title: Magnetic Resonance Based Non-Invasive Thermometry for Hyperthermic Treatment of Extremity Soft Tissue Sarcomas: A Multimodal Phase I/II Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Sarcoma
Keywords: stage I adult soft tissue sarcoma
stage II adult soft tissue sarcoma
stage III adult soft tissue sarcoma
stage IV adult soft tissue sarcoma
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2004-10-08
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: OBJECTIVES:

Primary

* Determine the feasibility 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.

Eligibility criteria: Inclusion Criteria:

* Patients will have histologically proven grade 2 or grade 3 soft tissue sarcoma.
* Karnofsky performance status ≥ 70.
* Life expectancy ≥ 6 months.
* There is no specific tumor size limitation, but the involved extremity must fit within the hyperthermia applicator.
* Patients must be ≥ 18 years of age.
* Patients who are to receive chemotherapy must have a left ventricular ejection fraction on resting MUGA scan of at least 45% to confirm adequate cardiac function
* Patients must competent to consent to be in the study and sign an approved informed consent.

Exclusion Criteria:

* Pregnant patients
* Patients with cardiac pacemakers and implanted defibrillators or other devices not compatible with ultrasound or microwave technology
* Patients who have any metal in their bodies including orthopedic rods, surgical clips, bullets, or shrapnel, etc. unless cleared by MRI staff and Hyperthermia physicians

Primary outcomes:
measure: Temperature Rise from Baseline
timeFrame: 1 hour
Secondary outcomes:
measure: Overall Survival
timeFrame: every 6 months for up to 5 years
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke Cancer Institute
state: North Carolina
Study officials:
affiliation: Duke Cancer Institute
name: Ellen L. Jones, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Duke University
name: Zeljko Vujaskovic, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Craciunescu OI, Stauffer PR, Soher BJ, Wyatt CR, Arabe O, Maccarini P, Das SK, Cheng KS, Wong TZ, Jones EL, Dewhirst MW, Vujaskovic Z, MacFall JR. Accuracy of real time noninvasive temperature measurements using magnetic resonance thermal imaging in patients treated for high grade extremity soft tissue sarcomas. Med Phys. 2009 Nov;36(11):4848-58. doi: 10.1118/1.3227506.