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Phase II Study of Laser Interstitial Thermal Therapy (LITT) in Recurrent Glioblastoma (NCT03022578)

Monteris Medical
Participant is being asked to take part in this study because participant has glioblastoma or anaplastic astrocytoma (AA) that has relapsed (come back) after treatment and the study doctor thinks that it is in participant's best interest to receive chemotherapy for the disease. Additionally, the study doctor thinks it may be in participant's best interest to also have a surgical procedure called laser interstitial thermal therapy (LITT). LITT is a minimally invasive (using small incisions) surgery method that uses lasers to destroy tumor cells. For the procedure, the study doctor uses the NeuroBlate system to perform LITT in combination with MRIs and software models to focus the lasers on affected brain cells. The goal of this clinical research study is to learn if the NeuroBlate system in combination with lomustine can help to control glioblastoma or anaplastic astrocytoma (AA) that has returned after treatment. The safety of the combination will also be studied. This is an investigational study. The NeuroBlate system is FDA approved and commercially available for different types of brain surgery. Lomustine is FDA approved and commercially available for the treatment of brain tumors. LITT using the NeuroBlate System in combination with lomustine for the treatment of glioblastoma is investigational. The study doctor can describe how the study drug and procedure are designed to work. Up to 34 participants will be enrolled in this study. All will take part at MD Anderson.
  • Procedure: Laser Interstitial Thermal Therapy
    LITT delivered directly to the tumor by a neurosurgeon.
    • LITT
  • Drug: Lomustine
    Lomustine administered by mouth at 90 mg/m2 on Day 1 for the first six week cycle. The dose of Lomustine may be increased to 110 mg/m2 starting with the second six week cycle, at the treating physician's discretion, as long as patient has not required dose modification for toxicity.
    • CeeNU
    • CCNU
  • Behavioral: Quality of Life Questionnaires
    Quality of life questionnaires completed at baseline, 14 days after LITT procedure, on Day 1 of each Lomustine cycle, 6 weeks after Lomustine stopped, and every 3 months during follow up.
    • Surveys
  • Device: The NeuroBlate System
    The NeuroBlate System used for thermal ablation of tumor utilizing the LITT procedure.
    Ages eligible for Study
    18 Years and older
    Genders eligible for Study
    All
    Accepts Healthy Volunteers
    No
    Inclusion Criteria:
    • Patients must have histologically-proven, recurrent supratentorial grade IV glioblastoma (or grade III IDH-wildtype anaplastic astrocytoma), for which a complete surgical resection is unsafe due to location, shape, or size of the tumor. Diagnosis of recurrence will be established by biopsy and frozen section immediately prior to initiating LITT procedure. If findings on frozen section are not consistent with recurrence (glioblastoma or recurrent IDH-wildtype anaplastic astrocytoma), decision to proceed with LITT procedure will be at the discretion of the neurosurgeon (only patients with histologically-proven recurrent tumor will be evaluable for efficacy).
    • All patients must sign an informed consent indicating that they are aware of the investigational nature of this study. Patients must have signed an authorization for the release of their protected health information. Patients must be registered prior to treatment on study.
    • Patients must be >/= 18 years old.
    • Patients must have a Karnofsky Performance Score (KPS) >60.
    • Patients must have received standard of care therapy with chemoradiation with temozolomide followed by adjuvant chemotherapy with temozolomide. Patients may have received one additional chemotherapy regimen (other than lomustine) in addition to adjuvant temozolomide prior to study entry (patients at either first or second recurrence are eligible).
    • In the context of this clinical trial, a lesion suitable for LITT is single, enhancing, supratentorial, at least 2 cm from inner table of skull over the hemispheric convexity, and >1 cm, but < 4 cm in cross-sectional dimension, including thalamic tumor (</= 3 cm).
    • Patients must have stable cardiovascular, neurovascular and neurological status, and be considered surgical candidates, as determined by any relevant pre-operative assessments, at the neurosurgeon's discretion.
    • Patients must not be receiving concurrent anti-tumor treatment and must have recovered from toxicity of prior treatment. Minimum interval required: 1) >6 weeks following nitrosourea chemotherapy; 2) >4 weeks after recovering from any non-nitrosourea drug or systemic investigational agent; 3) >2 weeks after receiving any non-cytotoxic anti-tumor drug; 4) > 4 weeks after receiving radiation therapy (>12 weeks following upfront concurrent chemoradiation); ); 5) >2 weeks following Optune device use.
    • Patients must not have previously undergone an intracranial LITT procedure. Patients must have adequate bone marrow function (white blood cell (WBC) > 3,000/µl, ANC > 1,500/mm3, platelet count of > 100,000/mm3, and hemoglobin > 10 gm/dl), adequate liver function (SGOT and bilirubin < 2 times ULN), and adequate renal function (creatinine < 1.5 mg/dL) before starting therapy. These tests must be performed within 14 days (+ 3 working days) prior to registration. Eligibility level for hemoglobin and platelets may be reached by transfusion.
    • Women of childbearing potential must have a negative B-HCG documented within 7 days prior to registration and must agree to practice adequate contraception as defined below. Non-childbearing potential (i.e., physiologically incapable of becoming pregnant), includes any female who has had: 1. A hysterectomy 2. A bilateral oophorectomy 3. A bilateral tubal ligation 4. Is post-menopausal: Subjects not using hormone replacement therapy (HRT) must have experienced total cessation of menses for >/= 1 year and be greater than 45 years in age, OR, in questionable cases, have a follicle stimulating hormone (FSH) value >40 mIU/mL and an estradiol value < 40pg/mL (<140 pmol/L).
    • (10. continued) Subjects using HRT must have experienced total cessation of menses for >= 1 year and be greater than 45 years of age OR have had documented evidence of menopause based on FSH and estradiol concentrations prior to initiation of HRT.
    • (11. continued) Childbearing potential includes any female who has had a negative serum pregnancy test within 7 days of study registration, and agrees to use adequate contraception. Acceptable contraceptive methods, when used consistently and in accordance with both the product label and the instructions of the physician, are as follows: 1. Complete abstinence from sexual intercourse for 14 days before starting treatment, through the treatment, and for at least 1 month after the last dose of temozolomide. 2. Oral contraceptive, either combined or progestogen alone. A second barrier method is required during the first month of treatment with oral contraceptives.
    • (12. continued) 3. Injectable progesterone 4. Implants of levonorgestrel. 5. Estrogenic vaginal ring. 6. Percutaneous contraceptive patches. 7. Intrauterine device (IUD) or intrauterine system (IUS) with a documented failure rate of less than 1% per year. 8. Male partner sterilization (vasectomy with documentation of azoospermia) prior to the female subject's entry into the study, and this male is the sole partner for that subject. 9. Double barrier method: condom and an occlusive cap (diaphragm or cervical/vault caps) with a vaginal spermicidal agent (foam/gel/film/cream/suppository). Female participants who are lactating should discontinue nursing prior to the first dose of temozolomide and should refrain from nursing throughout the treatment period and for 42 days following the last dose of lomustine.
    Exclusion Criteria:
    • Patients must not have received prior treatment with bevacizumab.
    • Patients must not have had prior treatment of glioblastoma with stereotactic radiosurgery, brachytherapy, or carmustine-impregnated wafers (Gliadel).
    • Patients must not have symptoms attributed to mass effect of the tumor (despite corticosteroid treatment) that would be better treated with debulking surgery, or wherein surgical debulking in the first 30 days following LITT procedure would be anticipated for symptom management.
    • Patients unable to undergo MRI are not eligible.
    • Patients with progression of multifocal tumors or tumors involving the posterior fossa (brainstem and cerebellum) will be excluded, as will patients where the anticipated treatment margin will be within 5 mm of critical intracranial structures (e.g., primary branches of cerebral vessels, dural sinuses, hypophysis or cranial nerves).
    • Patients may not have undergone previous treatment with lomustine.
    • Patients must not have any significant medical illnesses that in the investigator's opinion cannot be adequately controlled with appropriate therapy or would compromise the patient's ability to tolerate this therapy.
    • Patients with a history of any other cancer (except non-melanoma skin cancer or carcinoma in-situ of the cervix), unless in complete remission and off of all therapy for that disease for a minimum of 3 years are ineligible.
    • Patients must not have active infection or serious intercurrent medical illness.
    • Patients must not be pregnant/breast feeding and must agree to practice adequate contraception.
    • Patients must not have uncontrolled hypertension (systolic >180 mm hg or diastolic > 100 mg Hg), angina pectoris, cardiac dysrhythmia, or recent (within 6 weeks) intracranial hemorrhage.
    Study Drug/Procedure Administration:

    If participant is found to be eligible to take part in this study, participant will be scheduled to have the LITT procedure. An MRI will be performed the day before the procedure to produce images of participant's brain to direct the study doctor to the areas that should be treated. The LITT procedure will then be performed the next day. Participant will sign a separate consent form for the LITT procedure that explains this procedure and its risks in more detail.

    Participant will then receive standard of care hospitalization after surgery. Participant will have an MRI within 48 hours after the procedure to check the status of the disease.

    Participant will have 14 - 35 days for recovery from the LITT procedure. Participant will not take lomustine during this period. After the recovery period, participant will take lomustine by mouth on Day 1 of every 42-day cycle.

    Participant should take lomustine by mouth on an empty stomach before bed (2 hours after or 1 hour before food).

    Length of Treatment:

    Participant will take lomustine for up to 6 cycles. Participant will no longer be able to take the study drug if the disease gets worse, if participant has intolerable side effects, or if participant is unable to follow study directions.

    Participation in the study will be over after follow-up.

    Study Visits:

    On the day of the LITT procedure:

    - Participant will have a physical exam, including a neurological exam.

    - Participant will have MRI scans to help the surgeon perform LITT.

    - Blood (about 2 teaspoons) will be drawn for biomarker testing. Biomarkers are found in the blood and tissue and may be related to participant's reaction to the study drugs.

    - Tumor tissue will be collected to confirm the diagnosis and for biomarker testing during the LITT procedure.

    Within 2 days after the LITT procedure, participant will have an MRI.

    About 14 days after the LITT procedure:

    - Participant will have a physical exam, including a neurological exam.

    - Blood (about 2 teaspoons) will be drawn for routine tests. If participant can become pregnant, this will also include a pregnancy test.

    - Participant will complete the questionnaire about participant's quality of life.

    - Participant will have an MRI.

    When participant begins receiving lomustine, participant will have study visits in 42-day cycles.

    On Day 1 of each cycle:

    - Participant will have a physical exam, including a neurological exam.

    - Blood (about 2 teaspoons) will be drawn for routine test. If participant can become pregnant, this will also include a pregnancy test.

    - Participant will complete the questionnaire about participant's quality of life.

    - Participant will have an MRI.

    On Days 15 and 29 of each cycle, blood ( about 2 teaspoons) will be drawn for routine tests.

    At any time during the study, extra tests may be performed if the doctor thinks they are needed. The study doctor will tell participant more about any extra tests.

    End-of-Study Visit:

    About 6 weeks after stopping the study drug:

    - Participant will have a physical and neurological exam.

    - Participant will complete the questionnaire about participant's quality of life.

    - Participant will have an MRI scan.

    Follow-Up:

    Every 3 months after participant's last dose of the study drug, the study staff will call and ask how participant is feeling. This call should take about 5-10 minutes.

    If participant stops the study drug for any reason other than the disease getting worse, participant will visit the clinic every 3 months unless the disease gets worse. At these visits:

    - Participant will have a physical exam, including a neurological exam.

    - Participant will complete the questionnaire about participant's quality of life.

    - Participant will have an MRI.

    1 locations

    United States (1)
    • University of Texas MD Anderson Cancer Center
      recruiting
      Houston, Texas, United States, 77030
    Status:
    recruiting
    Type:
    Interventional
    Phase:
    Start:
    06 November, 2017
    Updated:
    06 November, 2017
    Participants:
    34
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