Laser Interstitial Thermal Therapy (LITT) for the Treatment of Pediatric Central Nervous System Tumors

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Brief Title

Laser Interstitial Thermal Therapy (LITT) for the Treatment of Pediatric Central Nervous System Tumors

Official Title

LITT for the Treatment of Newly Diagnosed Central Nervous System Tumors Located in Difficult to Surgically Access Regions of the Brain and Recurrent/Resistant Pediatric Central Nervous System Tumors Located Anywhere Within the Brain

Brief Summary

      Laser Interstitial Thermal Therapy (LITT) is a minimally invasive surgical technique that
      allows for biopsy and thermal ablation of brain tumors. Pediatric patients with brain tumors
      who are eligible and enroll in the trial will undergo LITT at the time of diagnosis or at the
      time of recurrence/progression rather than undergo an open craniotomy and tumor
      resection/biopsy. LITT will include a stereotactic biopsy followed by thermal ablation of the
      tumor. This study will monitor the safety and efficacy of LITT for the treatment of pediatric
      brain tumors.
    

Detailed Description

      Pediatric brain tumors have a variety of surgical options depending on the location and type
      of tumor. Complete or near complete surgical removal of pediatric brain tumors usually
      results in the best chance of survival or long-term control of the tumor. Surgical resection
      through an open craniotomy is the most common surgical treatment for accessible brain tumors.
      For tumors that are not surgically accessible or that are resistant to surgical intervention,
      treatment is limited to radiation and or chemotherapy, which can have significant long term
      toxicity in children.

      Laser interstitial thermal therapy (LITT) offers a minimally invasive surgical option to
      treat central nervous system (CNS) tumors. LITT uses laser energy delivered to a target (i.e.
      CNS tumor) through a fiberoptic catheter, which results in damage to intracellular proteins
      and DNA, and subsequent cell death. LITT provides a sharp demarcation between ablated and
      unharmed tissue, which, when combined with the ability to monitor and control the ablation
      via MR thermal imaging, results in a high level of precision and control. LITT may offer a
      treatment option for patients with deep brain lesions that are surgically inaccessible, such
      as tumors located in the thalamus, hypothalamus, basal ganglia and brainstem. LITT may also
      be a potential treatment for brain tumors which have recurred or persist despite conventional
      therapies including craniotomy. The MRI-guided laser probe used in LITT utilizes a much
      smaller surgical corridor through the brain to reach a deep lesion, potentially reducing the
      risk of complications.

      This study will offer LITT, rather than open craniotomy, for the diagnosis and treatment of
      newly diagnosed pediatric brain tumors located in difficult to surgically access regions of
      the brain and for the treatment of recurrent/resistant pediatric brain tumors located
      anywhere within the brain. The primary aim of this study is to determine if LITT is effective
      in reducing (or at least maintaining current rates of) tumor re-growth while lowering rates
      of post-surgical complications and improving quality of the procedure (i.e. shorter
      hospitalization and less use of pain medication compared to standard surgery for tumor
      removal/biopsy).

      This study has the following goals:

        1. Determine the frequency of post-operative side-effects in pediatric patients with newly
           diagnosed, difficult to surgically access CNS tumors or resistant/recurrent CNS tumors
           in any location who receive LITT treatment for tumor ablation.

        2. Examine the role of LITT in controlling newly diagnosed difficult to surgically access
           CNS tumors or resistant/recurrent pediatric CNS tumors in any location.

        3. Assess the correlation between the extent of tumor ablation and the rate of local tumor
           control.

        4. Characterize the MRI changes that occur in a pediatric tumor following LITT ablation.

      Patients enrolled on this study will require routine post-LITT follow-up, including
      intermittent physical exams to assess for side effects and MRIs to monitor the status of the
      tumor. The follow-up is similar to that performed following an open craniotomy and does not
      involve any extra studies. The side effects and rate of tumor control for each brain tumor
      patient enrolled on the trial will be compared to disease matched historical controls to
      learn more about the morbidity and efficacy of LITT in this population of patients compared
      to patients who underwent open craniotomy for resection/biopsy.
    


Study Type

Interventional


Primary Outcome

Morbidity of LITT for the treatment of pediatric brain tumors

Secondary Outcome

 Tumor control based on extent of tumor ablation

Condition

Brain Tumor

Intervention

Laser Interstitial Thermotherapy (LITT)

Study Arms / Comparison Groups

 Laser interstitial thermotherapy (LITT) treated patients
Description:  All patients enrolled on the trial will undergo LITT therapy per protocol. Side-effects and outcomes will be monitored and compared with disease matched historical controls.

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

10

Start Date

April 2015

Completion Date

January 1, 2020

Primary Completion Date

January 2020

Eligibility Criteria

        Inclusion Criteria:

          1. Age between 1 and 22 years.

          2. Karnofsky Performance Scale (for patients > 12 y/o) or Lansky Performance Score (for
             patients < 12y/o) must be > 50 assessed within two-weeks prior to enrollment.

          3. Tumor volume less than 10 cm3 is mandatory for high grade tumors.

          4. Tumor volume greater than 10 cm3 is acceptable in low grade tumors if the entire tumor
             can be ablated in more than one staged procedure.

          5. Histology must be available, obtained either at a prior surgery or at the time of LITT
             by stereotactic biopsy (except in germ cell tumors where elevation of tumor markers is
             diagnostic).

          6. Patients must meet the following histological and disease states:

        A) Newly diagnosed low-grade CNS tumor located in a site that is difficult to access
        surgically or recurrent/persistent low-grade CNS tumor (any site) despite treatment with
        conventional therapy. Tumor types include:

          1. Grade I or II glioma,

          2. Desmoplastic neuroectodermal tumor (DNET),

          3. Ganglioglioma,

          4. Desmoplastic infantile ganglioglioma/astrocytoma,

          5. Choroid plexus papilloma (CPP),

          6. Meningioma,

          7. Subependymal giant cell astrocytoma (SEGA),

          8. Craniopharyngioma

          9. Teratoma, or

         10. Other "low-grade CNS tumors"

        B) Newly diagnosed high-grade CNS tumor located in a site that is difficult to access
        surgically or recurrent/persistent high-grade CNS tumors (any site) despite treatment with
        conventional therapy. Tumor types include:

          1. Grade III or IV glioma,

          2. Ependymoma,

          3. Atypical teratoid rhabdoid tumor (ATRT),

          4. Choroid plexus carcinoma (CPC),

          5. Germ cell tumor (GCT),

          6. Medulloblastoma/primitive neuroectodermal tumor (PNET),

          7. Other "high grade CNS tumors".
      

Gender

All

Ages

1 Year - 22 Years

Accepts Healthy Volunteers

No

Contacts

Anne E Bendel, M.D., , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT02451215

Organization ID

1504-044


Responsible Party

Principal Investigator

Study Sponsor

Children's Hospitals and Clinics of Minnesota


Study Sponsor

Anne E Bendel, M.D., Principal Investigator, Children's Hospitals and Clinics of Minnesota


Verification Date

January 2020