A Pilot Study of Thermodox and MR-HIFU for Treatment of Relapsed Solid Tumors

You may not qualify if:

• Clinically significant unrelated systemic illness, such as serious infections, hepatic, renal or other organ dysfunction, which in the judgment of the Principal or Associate Investigator would compromise the patient's ability to tolerate study interventions.
• Patients who are pregnant or breast-feeding are not eligible for this study due to risks of fetal and teratogenic adverse events seen in animal/human studies with doxorubicin. Negative pregnancy tests must be obtained in girls who are post-menarchal. Males or females of reproductive potential may not participate unless they have agreed to use an effective contraceptive method beginning at the signing of informed consent and until at least 30 days after the last dose of study drug. The definition of adequate contraception will be based on the judgment of the principal investigator or designated associate.
• Implant or prosthesis within the path of the HIFU beam.
• Target pathway \<1 cm from nerve plexus, spinal canal, or bowel.
• Target lesion in the skull.
• Inability to undergo MRI and/or contraindication for MRI.
• Inability to tolerate stationary position during HIFU.
• Previous history of hypersensitivity to doxorubicin or its liposomal formulations.
• Patients currently receiving other anticancer agents.
• Patients currently receiving other investigational agents.