MR-guided High Intensity Focused Ultrasound (HIFU) on Pediatric Solid Tumors
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| ClinicalTrials.gov Identifier: NCT02076906 |
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Recruitment Status :
Active, not recruiting
First Posted : March 4, 2014
Last Update Posted : January 24, 2022
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| Condition or disease | Intervention/treatment | Phase |
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| Relapsed Pediatric Solid Tumors Refractory Pediatric Solid Tumors Rhabdomyosarcoma Ewing Sarcoma Osteosarcoma Neuroblastoma Wilms Tumor Hepatic Tumor Germ Cell Tumor Desmoid Tumor | Device: Magnetic Resonance High Intensity Focused Ultrasound | Phase 1 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 14 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Safety and Feasibility Study of Using MR-guided High Intensity Focused Ultrasound (HIFU) for the Ablation of Relapsed or Refractory Pediatric Solid Tumors |
| Actual Study Start Date : | April 2014 |
| Actual Primary Completion Date : | December 27, 2021 |
| Estimated Study Completion Date : | November 24, 2022 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: MR-HIFU
Magnetic Resonance High Intensity Focused Ultrasound (MR-HIFU) ablative therapy for children with recurrent or relapsed solid tumors.
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Device: Magnetic Resonance High Intensity Focused Ultrasound
MR-High intensity focused ultrasound (HIFU) is an ultrasound based technology which allows for non-invasive thermal ablation of tumors under the guidance of MR thermography.
Other Names:
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- 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.
- Disease response [ Time Frame: Up to 1 year ]We will preliminarily define tumor response from MR-HIFU ablative therapy assessed according to a modified Response Evaluation Criteria in Solid Tumors (RECIST). We will also evaluate functional tumor response using FDG-PET post MR-HIFU ablative treatment for patients with PET avid target lesions.
- Patient reported outcomes and quality of life measurements [ Time Frame: Up to 1 year ]We will use a validated symptom distress scale and quality of life metrics pre- and post-therapy at scheduled intervals.
- Immune Markers [ Time Frame: Pre-treatment, 1 day post treatment, 7 days post treatment ]Changes in immune markers from baseline and post therapy will be evaluated.
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| Ages Eligible for Study: | up to 30 Years (Child, Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
AGE: ≤ 30 years of age.
DIAGNOSIS:
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.
Immunotherapy: The last dose of immunotherapy (monoclonal antibody or vaccine) must be at least 4 weeks prior to study entry.
Biologic (anti-cancer agent): The last dose of all biologic agents for the treatment of the patient's cancer (such as retinoids or tyrosine kinase inhibitors) must be at least 7 days prior to study entry.
Radiation therapy: The last dose of radiation to more than 25 % of marrow containing bones (pelvis, spine, skull) must be at least 4 weeks prior to study entry. The last dose of all other local palliative (limited port) radiation must be at least 2 weeks prior to study entry.
Stem Cell Transplantation. At least 2 months post-autologous stem cell transplant or at least 3 months post-allogeneic transplant and recovered from toxicities without evidence of graft versus host disease and on stable doses of immunosuppressive medications if required.
Growth Factors. The last dose of colony stimulating factors, such as filgrastim, sargramostim, and erythropoietin, must be at least 1 week prior to study entry, the last dose of long-acting colony stimulating factors, such as pegfilgrastim, must be at least 2 weeks prior to study entry.
CONCURRENT THERAPIES:
No other anti-cancer therapy (chemotherapy, biological therapy, radiation therapy) is permitted during HIFU treatment and post treatment follow up for tolerability (see section 3.3).
PERFORMANCE STATUS:
Patients > 16 years old must have a Karnofsky performance level ≥ 50%, and children ≤ 16 years old must have a Lansky performance level ≥ 50% (See Appendix I).
Patients who are unable to walk because of paralysis or motor weakness, but who are up in a wheelchair will be considered ambulatory for the purpose of calculating the performance score.
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HEMATOLOGIC FUNCTION:
- Peripheral absolute neutrophil count (ANC) of ≥750/µL
- Platelet count ≥75,000/µL (may receive transfusions)
- RENAL FUNCTION: Age-adjusted normal serum creatinine OR a creatinine clearance ≥60 mL/min/1.73 m2.
- ADEQUATE PULMONARY FUNCTION: Defined as no dyspnea at rest, and a pulse oximetry >94% on room air if there is clinical indication for determination.
- Normal PT, PTT and INR < 1.5 x ULN (including patients on prophylactic anticoagulation)
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02076906
| United States, District of Columbia | |
| Children's National Medical Center | |
| Washington, District of Columbia, United States, 20010 | |
| United States, Ohio | |
| Cincinnati Children's Hospital Medical Center | |
| Cincinnati, Ohio, United States, 45229 | |
| Principal Investigator: | AeRang Kim, MD, PhD | Children's National Research Institute |
| Responsible Party: | AeRang Kim, MD, PhD, Children's National Research Institute |
| ClinicalTrials.gov Identifier: | NCT02076906 |
| Other Study ID Numbers: |
HIFU Pediatric Solid Tumors |
| First Posted: | March 4, 2014 Key Record Dates |
| Last Update Posted: | January 24, 2022 |
| Last Verified: | January 2022 |
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relapsed pediatric solid tumors refractory pediatric solid tumors high intensity focused ultrasound rhabdomyosarcoma Ewing's sarcoma osteosarcoma |
neuroblastoma Wilms' tumor hepatic tumors germ cell tumors desmoid tumor |
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Neoplasms Sarcoma Neuroblastoma Neoplasms, Germ Cell and Embryonal Osteosarcoma Rhabdomyosarcoma Sarcoma, Ewing Wilms Tumor Fibromatosis, Aggressive Liver Neoplasms Neoplasms, Connective and Soft Tissue Neoplasms by Histologic Type Neuroectodermal Tumors, Primitive, Peripheral Neuroectodermal Tumors, Primitive Neoplasms, Neuroepithelial |
Neuroectodermal Tumors Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Bone Tissue Neoplasms, Connective Tissue Myosarcoma Neoplasms, Muscle Tissue Neoplasms, Complex and Mixed Kidney Neoplasms Urologic Neoplasms Urogenital Neoplasms Neoplasms by Site Neoplastic Syndromes, Hereditary Kidney Diseases Urologic Diseases |