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SarcomaPhase 1/2NCT00093509

MRI Sarcoma Non Invasive Thermometry

A Phase 1/2 study testing doxorubicin hydrochloride, ifosfamide and mesna and hyperthermia treatment with an MRI Compatible Radiofrequency Extremity Hyperthermia Applicator in people with Sarcoma, run by Mark Dewhirst at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Sarcoma
What is being tested?
doxorubicin hydrochloride, ifosfamide and mesna and hyperthermia treatment with an MRI Compatible Radiofrequency Extremity Hyperthermia Applicator
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
1 siteUnited States
Study dates
Nov 1999to Oct 2009
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Duke Cancer Institute

    Durham, North Carolina, 27710

Other trials in United States

About this study

Official title: Magnetic Resonance Based Non-Invasive Thermometry for Hyperthermic Treatment of Extremity Soft Tissue Sarcomas: A Multimodal Phase I/II Study

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.

Read the 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.

Conditions
Sarcoma
Being tested
doxorubicin hydrochloride, ifosfamide and mesna, hyperthermia treatment with an MRI Compatible Radiofrequency Extremity Hyperthermia Applicator, radiation therapy
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
Medical subject headings
Sarcoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • doxorubicin hydrochlorideDrug

    Also called Adriamycin

    To be dosed at 75 mg/m2 i.v. push every 4 weeks for 4 cycles. This treatment is optional and will not be used on all subjects.

  • ifosfamide and mesnaDrug

    Also called Ifosfamide - Ifex, Mesna - sodium 2-mercapto-ethanesulphonate

    2 gm / m2 ifosfamide mixed in 1000 cc D5W infused continuously over 24 hours daily for 6 days (144 hours); total ifosfamide dose 12 gm/ m2. For the day infusion only MESNA (sodium 2-mercapto-ethanesulphonate) is mixed with ifosfamide as above and given at 2.5 gm / m2 / 24 hours.

  • hyperthermia treatment with an MRI Compatible Radiofrequency Extremity Hyperthermia ApplicatorProcedure or surgery

    Patients will receive hyperthermia throughout the course of radiotherapy delivered once weekly for a total of 5 treatments. Each treatment will last 1-2 hours with a goal of delivering a cumulative thermal dose of 10-100 CEM 43˚T90.

  • radiation therapyRadiation

    External beam megavoltage (≥ 4 MV) beams will be used at SSD, SAD ≥ 70 cm at a dose rate of > 100 cGy/min. Fraction sizes of 180 cGy will be used 5 times per weeks in a continuous course. Total dose will be 45 Gy + 10%, consistent with sites being treated.

Study groups in NCT00093509
Study groupRoleWhat they receive
Magnetic Resonance Based ThermometryExperimentalPatients will receive hyperthermia throughout the course of radiotherapy delivered once weekly for a total of 5 treatments. Each treatment will last 1-2 hours with a goal of delivering a cumulative thermal dose of 10-100 CEM 43˚T90. Interstitial temperature measurements will be taken by placing a single (less than or equal to) 15 gauge thermometry catheter into the tumor. In addition to hyperthermia treatment and radiation therapy all patients will receive conventional surgery for the removal of their tumors. Some patients will also receive chemotherapy if their treating physician thinks it is the their best interested (including the possibility of doxorubicin hydrochloride or ifosfamide and mesna).
Receives: Drug: doxorubicin hydrochloride; Drug: ifosfamide and mesna; Procedure: hyperthermia treatment with an MRI Compatible Radiofrequency Extremity Hyperthermia Applicator; Radiation: radiation therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Temperature Rise from Baseline

    MR-based thermometry measures: We are assessing agreement between the non-invasive MR measurements versus the invasive interstitial point measurements. The equivalence of median temperature measured within one or more MR ROI's (regions-of-interest in the MR image) and temperatures measured invasively in tissue immediately adjacent to those ROI's;

    Measured: 1 hour

Secondary outcomes (1)

  1. Overall Survival

    Measured: every 6 months for up to 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Oct 2004 (estimated)
  2. Study startNov 1999
  3. Primary completionJul 2007
  4. Study completionOct 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
15 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00093509
Sponsor's protocol ID
Pro00008831
Other IDs
DUMC-1308-04-7R5, DUMC-G880018, CDR0000388048
Status last verified
Aug 2014
First submitted
6 Oct 2004
Last updated
1 Sep 2014
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 19994492

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing doxorubicin hydrochloride, ifosfamide and mesna and hyperthermia treatment with an MRI Compatible Radiofrequency Extremity Hyperthermia Applicator in people with Sarcoma, run by Mark Dewhirst at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Temperature Rise from Baseline (time frame: 1 hour). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00093509, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2014; AzTrials last refreshed its copy on 27 Oct 2026.

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