MR-guided High Intensity Focused Ultrasound (HIFU) on Pediatric Solid Tumors

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Brief Title

MR-guided High Intensity Focused Ultrasound (HIFU) on Pediatric Solid Tumors

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

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.
    

Study Phase

Phase 1

Study Type

Interventional


Primary Outcome

Toxicity

Secondary Outcome

 Disease response

Condition

Relapsed Pediatric Solid Tumors

Intervention

Magnetic Resonance High Intensity Focused Ultrasound

Study Arms / Comparison Groups

 MR-HIFU
Description:  Magnetic Resonance High Intensity Focused Ultrasound (MR-HIFU) ablative therapy for children with recurrent or relapsed solid tumors.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Device

Estimated Enrollment

14

Start Date

April 2014

Completion Date

April 2021

Primary Completion Date

April 2021

Eligibility Criteria

        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.

          -  HEMATOLOGIC FUNCTION:

               1. Peripheral absolute neutrophil count (ANC) of ≥750/µL

               2. 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.
      

Gender

All

Ages

N/A - 30 Years

Accepts Healthy Volunteers

No

Contacts

AeRang Kim, MD, PhD, 202-476-6755, [email protected]

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT02076906

Organization ID

HIFU Pediatric Solid Tumors


Responsible Party

Sponsor-Investigator

Study Sponsor

AeRang Kim


Study Sponsor

AeRang Kim, MD, PhD, Principal Investigator, Children's National Research Institute


Verification Date

February 2021