Safety and Feasibility Study of Using MR-guided High Intensity Focused Ultrasound (HIFU) for the Ablation of Relapsed or Refractory Pediatric Solid Tumors
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Relapsed Pediatric Solid Tumors
- Sponsor
- AeRang Kim
- Enrollment
- 7
- Locations
- 2
- Primary Endpoint
- Toxicity
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
The purpose of this study is to determine if Magnetic Resonance guided High Intensity Focused Ultrasound ablative therapy is safe and feasible for children, adolescents, and young adults with refractory or relapsed solid tumors.
Detailed Description
Magnetic Resonance (MR)-guided high intensity focused ultrasound (HIFU) is an innovative technique that allows for non-invasive thermal ablation of tissue. Advantages over conventional local tumor control such as surgery, radiation, or radiofrequency are that MR-HIFU is completely non-invasive, non-ionizing, and enables ablation of large tumor volumes with avoidance of adjacent tissue injury. This study will evaluate the safety and feasibility of MR-HIFU ablative therapy in children, adolescents, and young adults with refractory or relapsed solid tumors that are located in bone or soft tissue in close proximity to bone. Patients ≤ 30 years of age with refractory or relapsed solid tumors with measurable target lesions that are located in bone or soft tissue in close proximity to bone are eligible. Tolerability will be defined during the 14 days following MR-HIFU ablation. Patients will continue to be followed for tumor response and secondary outcomes for up to one year post ablation treatment.
Investigators
AeRang Kim
MD, PhD
Children's National Research Institute
Eligibility Criteria
Inclusion Criteria
- •AGE: ≤ 30 years of age.
- •Histologically confirmed malignant 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, germ cell tumors, and desmoid tumors.
- •TUMOR LOCATION: Target lesion(s) must be located in bone or soft tissue in close proximity to bone. Target lesions must be reachable within the normal safety margins of HIFU as specified in the instructions for use.
- •TARGET LESION(S): Radiographically evaluable or measurable solid tumor target lesion(s).
- •THERAPEUTIC OPTIONS:
- •Malignant Tumor: The patient's cancer must have relapsed after or failed to respond to frontline curative therapy and there must not be other potentially curative treatment options available. Curative therapy may include surgery, radiation therapy, chemotherapy, or any combination of these modalities.
- •PRIOR THERAPY:
- •Patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering on this study.
- •No limitation on the number of prior chemotherapy regimens that the patient may have received prior to study entry.
- •Myelosuppressive chemotherapy: The last dose of all myelosuppressive anticancer drugs must be at least 3 weeks prior to study entry.
Exclusion Criteria
- •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 the general anesthetic required for the procedure.
- •Implant or prosthesis or scar tissue within the path of the HIFU beam.
- •Target \<1 cm from nerve plexus, spinal canal, bladder, bowel
- •Target in contact with hollow viscera
- •Lesion in the skull
- •Inability to undergo MRI and/or contraindication for MRI
- •Inability to tolerate stationary position during HIFU
- •Patients currently receiving other anticancer agents.
- •Patients currently receiving other investigational agents.
Outcomes
Primary Outcomes
Toxicity
Time Frame: 28 days following ablative therapy
Toxicity will be evaluated using CTCAEv4. Adverse events will be summarized descriptively with tabulations of adverse event type, severity, and relationship to study treatment.
Secondary Outcomes
- Disease response(Up to 1 year)
- Patient reported outcomes and quality of life measurements(Up to 1 year)
- Immune Markers(Pre-treatment, 1 day post treatment, 7 days post treatment)