Trials / Terminated
TerminatedNCT02536183
A Phase I Study of Lyso-thermosensitive Liposomal Doxorubicin and MR-HIFU for Pediatric Refractory Solid Tumors
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
- Status
- Terminated
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 2 (actual)
- Sponsor
- AeRang Kim · Academic / Other
- Sex
- All
- Age
- 30 Years
- Healthy volunteers
- Not accepted
Summary
This study is looking to determine the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of lyso-thermosensitive liposomal doxorubicin (LTLD) administered in combination with MR-HIFU in children with relapsed/refractory solid tumors, which may include but are not limited to rhabdomyosarcoma and other soft tissue sarcomas, Ewing's sarcoma family of tumors, osteosarcoma, neuroblastoma, Wilms' tumor, hepatic tumors, and germ cell tumors.
Detailed description
This is phase 1 trial of LTLD with MR-HIFU induced heating in children and young adults with relapsed/refractory solid tumors. Part A of the trial will be a traditional dose escalation study to determine the pediatric MTD/RP2D of LTLD combined with MR-HIFU ablation which allows for release of doxorubicin in the ablation zone and peri-ablation margins. Part B of the trial will combine LTLD at the MTD/RP2D with MR-HIFU induced mild hyperthermia (MHT) in an expanded cohort.
Conditions
- Pediatric Cancer
- Solid Tumors
- Rhabdomyosarcoma
- Ewing Sarcoma
- Soft Tissue Sarcomas
- Osteosarcoma
- Neuroblastoma
- Wilms Tumor
- Hepatic Tumor
- Germ Cell Tumors
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Magnetic resonance high intensity focused ultrasound | Magnetic resonance (MR)-high intensity focused ultrasound (HIFU) provides precise controlled delivery of heat by focusing ultrasound energy inside a lesion using an external applicator that is completely non-invasive and non-ionizing. |
| DRUG | Lyso-thermosensitive liposomal doxorubicin | A heat-activated formulation of liposomal doxorubicin with unique property of heat-activated release of doxorubicin, an active agent in most pediatric solid tumors. |
Timeline
- Start date
- 2016-10-01
- Primary completion
- 2022-10-01
- Completion
- 2022-10-01
- First posted
- 2015-08-31
- Last updated
- 2023-08-29
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT02536183. Inclusion in this directory is not an endorsement.