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| Sponsor: | InSightec |
|---|---|
| Information provided by (Responsible Party): | InSightec |
| ClinicalTrials.gov Identifier: | NCT00656305 |
Purpose
A Pivotal Study to Evaluate the Effectiveness and Safety of ExAblate Treatment of Metastatic Bone and Multiple Myeloma Tumors for the Palliation of Pain in Patients Who are not Candidates for Radiation Therapy
| Condition | Intervention | Phase |
|---|---|---|
|
Bone Metastases Multiple Myeloma |
Device: ExAblate 2000 Device: Sham |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment |
| Official Title: | A Pivotal Study to Evaluate the Effectiveness and Safety of ExAblate (Magnetic Resonance-guided Focused Ultrasound Surgery) Treatment of Metastatic and Multiple Myeloma Bone Tumors for the Palliation of Pain in Patients Who Are Not Candidates for Radiation Therapy |
| Estimated Enrollment: | 148 |
| Study Start Date: | March 2008 |
| Estimated Study Completion Date: | December 2011 |
| Estimated Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
ExAblate Treatment Test Arm
|
Device: ExAblate 2000
MR guided focused ultrasound.
Other Names:
|
|
Sham Comparator: 2
ExAblate Sham Control Arm
|
Device: ExAblate 2000
MR guided focused ultrasound.
Other Names:
Device: Sham
sham comparator
|
Bone is the third most common organ involved by metastatic disease behind lung and liver [7]. In breast cancer, bone is the second most common site of metastatic spread, and approximately 85% of patients dying of breast cancer have bone metastasis. Breast and prostate cancer metastasize to bone most frequently, which reflects the high incidence of both these tumors, as well as their prolonged clinical courses.
The increasing longevity of the population coupled with better therapeutic management of cancer patients contributes to the high incidence and prevalence of metastatic bone lesions. Pain from bone metastases is the most common cause of cancer pain and as more patients are living with bone metastases, improving their quality of life becomes a major challenge. In patients who die from breast, prostate, and lung cancer, autopsy studies have shown that up to 85% have evidence of bone metastases at the time of death [7-9].
Current treatments for patients with bone metastases are primarily palliative and include localized therapies [10], systemic therapies (chemotherapy, hormonal therapy, radiopharmaceutical, and bisphosphanates), and analgesics (opioids and non-steroidal anti-inflammatory drugs). Recently, radiofrequency ablation has been tested as a treatment option for bone metastases [11]. The main goals of these treatments are improvement of quality of life and functional level. These goals can be further described:
Treatment with external beam radiation therapy (EBRT) is the standard of care for patients with localized bone pain, and results in the palliation of pain in the majority of these patients. More than 66% of patients with a limited number of well-localized bony metastases can be treated effectively by external-beam irradiation. However, approximately 30% of patients treated with radiation therapy do not experience pain relief [8, 12-16]. Furthermore, there is an increased risk of pathologic fracture in the peri-irradiation period due to an induced hyperemic response at the periphery of the tumor. This weakens the adjacent bone and increases the risk of spontaneous fracture. Adding to this, patients who have recurrent pain at a site previously irradiated may not be eligible for further radiation therapy secondary to limitations in normal tissue tolerance. The speed of response to radiation therapy varies; from the patients that respond most symptomatic bony metastases begin to respond over the course of 10 to 14 days, 70% of patients experience some pain relief within 2 weeks of starting therapy and, within 3 months 90% of patients achieve pain relief.
Patients, who had EBRT and failed to improve, may need to seek other therapies such as radio frequency ablation, surgical resection, etc., which are less efficient and have higher treatment related morbidity. Because the ExAblate system is designed to non-invasively ablate tissue, ExAblate may meet the need of these EBRT failed patients. The ExAblate system has the potential to achieve the first three of the four above mentioned goals, as well as changing the treatment limits and resulting morbidity in accordance with the above-mentioned goals [17]. The palliative effect of ExAblate is achieved by heating the bone periosteum, thus ablating the sensory origin of the pain.
Based on the FDA approved phase-1 initial study (IDE # G050177 ) results and the results of the study that was performed outside the United States that the sponsor has done, palliation effects are significant in terms of mean improvement, the number of treated patients who reported symptomatic improvement and in their potential durability.
Based on the above ExAblate treatment has a potential to be treatment of choice for radiation
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion criteria:
Patients who are suffering from symptoms of bone metastases or multiple myeloma bone lesions and are radiation failure patients:
Radiation failure candidates are those who have received radiation without adequate relief from metastatic bone pain as determined by the patient and treating physician, those for whom their treating physician would not prescribe radiation or additional radiation treatments, and those patients who refuse additional radiation therapy,
Patients on ongoing chemotherapy regimen for at least 1 month at the time of eligibility:
- with same chemotherapy regimen (as documented from patient medical dossier),
And
- Worst pain NRS still >= 4
And
- do NOT plan to initiate a new chemotherapy for pain palliation should be eligible for the study.
Exclusion Criteria:
Patients who either
OR
- Patients with surgical stabilization of tumor site with metallic hardware
Patients with unstable cardiac status including:
Contacts and Locations| United States, California | |
| University of California San Diego | Recruiting |
| La Jolla, California, United States, 92093-0987 | |
| Contact: Lilly Pacheco 619-471-0676 lpacheco@ucsd.edu | |
| Principal Investigator: Wade Wong | |
| Stanford University Medical Center | Recruiting |
| Stanford, California, United States, 94305-5642 | |
| Contact: Kamil Unver 650-725-9810 KUnver@stanfordmed.org | |
| Contact: Peji Ghanouni 650-799-1804 pejman.ghanouni@gmail.com | |
| Principal Investigator: Peji Ghanouni | |
| United States, Florida | |
| University MRI & Diagnostic Imaging Centers | Recruiting |
| Boca Raton, Florida, United States, 33431 | |
| Contact: Fred Steinberg 561-362-9191 fsteinberg@universitymri.com | |
| Contact: Kim Thomas 561-362-9191 kimthomas@exploreflora.com | |
| Principal Investigator: Fred Steinberg | |
| Moffitt Cancer Center | Recruiting |
| Tampa, Florida, United States, 33612 | |
| Contact: Ann Creamer 813-745-2264 Ann.Creamer@moffitt.org | |
| Principal Investigator: Junsung Choi | |
| United States, Massachusetts | |
| Brigham and Women's Hospital | Recruiting |
| Boston, Massachusetts, United States, 02115 | |
| Contact: Louise Greenberg 617-732-5441 LGREENBERG@PARTNERS.ORG | |
| Contact 617-732-6313 MHURWITZ@LROC.HARVARD.EDU | |
| Principal Investigator: Mark Hurwitz, MD | |
| United States, New Jersey | |
| Virtua Health | Withdrawn |
| Vorhees, New Jersey, United States, 08043 | |
| United States, New York | |
| Weill Cornell Medical College | Recruiting |
| New York, New York, United States, 10065 | |
| Contact: Amelia Ng 212-746-2194 ameng@med.cornell.edu | |
| Principal Investigator: Robert Min, MD | |
| Memorial Sloan Kettering Cancer Center | Withdrawn |
| New York, New York, United States, 10065 | |
| United States, Pennsylvania | |
| Fox Chase Cancer Center | Recruiting |
| Philadelphia, Pennsylvania, United States, 19111 | |
| Contact: Elaine Callahan 215-728-3117 E_Callahan@fccc.edu | |
| Principal Investigator: Joshua Meyer, M.D. | |
| United States, Texas | |
| Methodist Hospital Research Institute | Withdrawn |
| Houston, Texas, United States, 77030 | |
| United States, Virginia | |
| University of Virginia Health System | Recruiting |
| Charlottesville, Virginia, United States, 22908 | |
| Contact: Katie Sullivan 434-243-7231 KLS8D@hscmail.mcc.virginia.edu | |
| Principal Investigator: Paul Read, MD | |
| Canada, Ontario | |
| Toronto General Hospital | Recruiting |
| Toronto, Ontario, Canada, M5G 2C4 | |
| Contact: Cheryl Geen-Smith 416-340-4800 ext 6639 cgsmith@uhnresearch.ca | |
| Principal Investigator: Walter Kucharczyk, MD | |
| Israel | |
| Rambam medical Center -The Pain palliation unit | Recruiting |
| Haifa, Israel, 31096 | |
| Contact: May Hadad 972-4-8541931 | |
| Principal Investigator: Eilon Eisenberg, MD | |
| Sheba Medical Center | Recruiting |
| Tel Hashomer, Israel, 52621 | |
| Contact: Rama Sapir 02-6555768 sapir@szmc.org.il | |
| Contact: Natasha Bardy nataliabard@rambler.ru | |
| Principal Investigator: Raphael Pfeffer, MD | |
| Italy | |
| University of Rome "La Sapienza" | Recruiting |
| Rome, Italy, 00161 | |
| Contact: Alessandro Napoli +39 (06) 4-997-4511 | |
| Principal Investigator: Carlo Catalano | |
| Russian Federation | |
| Rostov State Research Institute of Oncology | Recruiting |
| Rostov on Don, Russian Federation, 344037 | |
| Contact: Dmitry Iozeffi +78633003060 iozeffi@gmail.com | |
| Principal Investigator: Dmitry Iozeffi | |
| N. N. Petrov Institute of Oncology | Recruiting |
| St. Petersburg, Russian Federation, 197758 | |
| Contact: V. G. Turkevich +78125968607 5968900@mail.ru | |
| Principal Investigator: S. V. Kanaev | |
More Information
| Responsible Party: | InSightec |
| ClinicalTrials.gov Identifier: | NCT00656305 History of Changes |
| Other Study ID Numbers: | BM004 |
| Study First Received: | April 2, 2008 |
| Last Updated: | October 31, 2011 |
| Health Authority: | United States: Food and Drug Administration |
|
Bone Cancer Pain Palliation Metastasis Multiple Myeloma Breast Cancer |
Lung Cancer Prostate Cancer cancer related Pain Tumors |
|
Multiple Myeloma Neoplasms, Plasma Cell Neoplasm Metastasis Bone Neoplasms Bone Marrow Diseases Neoplasms by Histologic Type Neoplasms Hemostatic Disorders Vascular Diseases Cardiovascular Diseases Paraproteinemias |
Blood Protein Disorders Hematologic Diseases Hemorrhagic Disorders Lymphoproliferative Disorders Immunoproliferative Disorders Immune System Diseases Neoplastic Processes Pathologic Processes Neoplasms by Site Bone Diseases Musculoskeletal Diseases |