Clinical trial NCT02970448: Expedited Laser Interstitial Thermal Therapy + Chemoradiation For Newly Diagnosed High Grade Gliomas
Official title: Expedited Laser Interstitial Thermal Therapy and Chemoradiation for Patients With Newly Diagnosed High Grade Gliomas
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: EARLY_PHASE1
Conditions: High Grade Glioma
Keywords: LITT
Brain Tumor
Temozolomide
Lead sponsor: Case Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2016-11-22
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The investigators of this study want to see if shortening the total treatment time for brain tumors is safe.The treatment for participant's brain tumors is laser surgery (Laser Interstitial Thermal Therapy (LITT)) followed by radiation with chemotherapy. For participants, the total time of treatment from surgery to the end of radiation and chemotherapy is about l 0 weeks long. This study asks whether it is safe to shorten the total treatment to 7 weeks.

To shorten the total treatment time, investigators want to see if it is safe to start radiation with chemotherapy within 5 days after surgery. Usually patients start their radiation with chemotherapy about 21-28 days after the surgery.

Shortening the total time of treatment may allow investigators to kill the cancer cells more effectively.

Detailed description: Primary Objective To determine the safety and feasibility of reducing the time interval between LITT and the start of chemoradiation to ≤ 7 days.

The primary endpoint (binary) for safety/feasibility will be defined as the occurrence of one or more of the following within each patient during a window of observation from the completion LITT to the end of radiation:

* Wound dehiscence, grade 3 {CTCAE v4.0)
* Seizures, grade 3 (CTCAE v4.0) in patients without a prior history of seizures and on adequate anti-seizure medications
* Cerebral edema, grade 4 (CTCAE v4.0)
* Failure to complete of 60 Grays (Gy) of radiation

Secondary Objective(s) To estimate the proportion of patients requiring adjustments in radiation plans post-LITT.

Secondary Endpoint: Requirement of an adjustment in the radiation plan to account for post-LITT tissue distortion.

Study design This study will be a 2-stage, single-institution safety and feasibility trial. Patients will be evaluated by a neuro-oncology team consisting of a neurosurgeon trained in LITT, radiation oncologist and medical oncologist prior to surgery. Evaluable patients will have a histologic diagnosis of high-grade glioma, complete LITT, and are candidates for standard concurrent radiation (60 Gy) and temozolomide as determined by the treating physician. Concurrent chemoradiation will begin within 7 days of the LITT procedure.

Eligibility criteria: Inclusion Criteria:

* Subjects must have suspected high grade glioma by MRI
* Subjects must have received no prior therapies for this disease.
* Patients must be considered appropriate candidates for LITT.
* Karnofsky Performance status ≥ 60%
* Subjects must have normal organ and marrow function as defined below. Measures of function must be within 14 days prior to registration.

  * Absolute neutrophil count (ANC) ≥ 1500 cells/mm3, platelets ≥ 100,000 cells/mm3, hemoglobin ≥ 10.0 g/dl. Use of transfusion or other intervention to achieve this hemoglobin level is acceptable.
  * Blood urea nitrogen ≤ 30mg/dl and creatinine ≤ 1.7 mg/dl
  * Bilirubin ≤ 2.0 mg/dl, Aspartate aminotransferase/ Alanine aminotransferase (AST/ALT) ≤ 3x upper limit of normal
  * Electrocardiogram without evidence of acute cardiac ischemia
  * Prothrombin time/international normalized ratio (PT INR) \<1.4
* Women of childbearing potential and male participants must practice adequate contraception.
* For women of childbearing age, negative pregnancy test within 14 days prior to registration
* Subjects must have the ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

* Participants not eligible to obtain MRI with and without contrast
* Recurrent High grade gliomas (HGG)
* Cerebral edema, grade 3 or greater prior to surgery
* Post-operative complications including significant neurological decline or hemorrhage that causes a drop in KPS to less than 60 or renders the patient not suitable for chemoradiation as determined by their treating physician
* Severe co-morbidity that would confer excess risk of surgery, radiation or chemotherapy, as determined by the treating physician.

Any other major medical illnesses or psychiatric impairments that in the investigator's opinion will prevent administration of completion of protocol therapy

* Any other major medical illnesses or psychiatric impairments that in the investigator's opinion will prevent administration or completion of protocol therapy.
* Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception; this exclusion is necessary because the treatment involved in this study may be significantly teratogenic.
* Participants receiving other investigational agents.

Primary outcomes:
measure: Study safety as determined by the number of patients who experience pre-specified adverse events
timeFrame: Up to 12 weeks after LITT therapy
Secondary outcomes:
measure: Number of patients with adjustments to radiation plan to account for post-LITT tissue distortion
timeFrame: Up to 12 weeks after LITT therapy
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center
name: Jennifer Yu, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: