| A Phase I/II Study
Evaluating the Maximum Tolerated Dose, Bioequivalence/Pharmacokinetics,
Safety, and Efficacy of Hyperthermia and ThermoDox (Lyso-Thermosensitive
Liposomal Doxorubicin) in Patients With Local-Regional Recurrent Breast
Cancer. |
Thermodox with microwave hyperthermia (heat) |
breast cancer |
17 |
I and II |
completed |
| Phase II Open-Label Trial
of Thermal Ablation and Lyso-Thermosensitive
Liposomal Doxorubicin (Thermodox) for Metastatic Colorectal Cancer
(mCRC) Liver Lesions |
Thermodox |
metastatic
colorectal cancer (mCRC) |
3 |
II |
terminated |
| A Phase I Dose Escalation Tolerability
Study of ThermoDox (Thermally
Sensitive Liposomal Doxorubicin) in Combination With Radiofrequency
Ablation (RFA) of Primary and Metastatic Tumors of the Liver |
Thermodox |
hepatocellular carcinoma |
30 |
I |
completed |
| PanDox: Feasibility of Enhanced Chemotherapy Delivery to Nonresectable
Primary Pancreatic Tumors Using Thermosensitive Liposomal Doxorubicin
(ThermoDox) and Focused Ultrasound |
Thermodox and FUS |
pancreatic ductal adenocarcinoma |
18 |
I |
not recruiting yet |
| A Pilot
Study of Lyso-thermosensitive Liposomal Doxorubicin
(LTLD, ThermoDox) and Magnetic Resonance-Guided High Intensity Focused
Ultrasound (MR-HIFU) for Treatment of Relapsed or Refractory Solid
Tumors |
Thermodox and MR-HIFU |
solid tumors,
soft tissue sarcoma, ewing sarcoma, malignant
epithelial neoplasm, rhabdomyosarcoma, Wilms tumor, hepatic tumor,
germ cell tumor, bone metastases |
14 |
II |
not recruiting yet |
| A Phase III, Randomized,
Double-Blind, Dummy-Controlled Study
of ThermoDox (Lyso-Thermosensitive Liposomal Doxorubicin-LTLD) in
Hepatocellular Carcinoma (HCC) Using Standardized Radiofrequency Ablation
(RFA) Treatment Time ≥45 minutes for Solitary Lesions ≥3
cm to ≤7 cm |
Thermodox |
hepatocellular
carcinoma |
556 |
III |
completed |
| A Phase I Study of Lyso-thermosensitive Liposomal
Doxorubicin
(LTLD, ThermoDox) and Magnetic Resonance-Guided High-Intensity Focused
Ultrasound (MR-HIFU) for Relapsed or Refractory Solid Tumors in Children,
Adolescents, and Young Adults |
Thermodox and MR-HIFU |
pediatric cancer, solid tumors, rhabdomyosarcoma, Ewing sarcoma,
soft tissue sarcomas, osteosarcoma, neuroblastoma, Wilms tumor, hepatic
tumor, germ cell tumors |
34 |
I |
recruiting |
| Phase II Trial of Phillips MRI-Guided
High-Intensity Focused
Ultrasound (Sonalleve) and Lyso-thermosensitive Liposomal Doxorubicin
(ThermoDox) for Palliation of Painful Bone Metastases |
Thermodox and HIFU |
painful bone metastases, breast
carcinoma, nonsmall cell lung
cancer, small cell lung cancer, adenocarcinoma |
0 |
II |
withdrawn |
| A Proof
of Concept Study to Investigate the Feasibility of
Targeted Release of Doxorubicin From Lyso-thermosensitive Liposomal
(LTSL) Doxorubicin (ThermoDox) Using Focused Ultrasound in Patients
With Primary or Secondary Liver Tumors |
Thermodox and
FUS |
liver tumor |
10 |
I |
completed |
| Heat-Activated Target Therapy
(Radiotherapy + Hyperthermia
+ Lyso-Thermosensitive Liposomal Doxorubicin) of Local-Regional Relapse
in Breast Cancer Patients |
Thermodox and radiation therapy |
breast cancer |
70 |
II |
suspended |
| A Phase III, Randomized, Double-Blinded,
Dummy-Controlled Study
of the Efficacy and Safety of ThermoDox (Thermally Sensitive Liposomal
Doxorubicin) in Combination With Radiofrequency Ablation (RFA) Compared
to RFA-Alone in the Treatment of Non-Resectable Hepatocellular Carcinoma |
Thermodox |
hepatocellular carcinoma |
701 |
III |
completed |
| A Phase I, Dose Escalation and Pharmacokinetics Study of Temperature
Sensitive Liposome Encapsulated Doxorubicin (ThermoDox) and Hyperthermia
in Patients With Local-Regionally Recurrent Breast Cancer |
Thermodox |
breast cancer |
29 |
I |
terminated |
