IDH Family WildtypePhase 2NCT03022578
Laser Interstitial Thermal Therapy and Lomustine in Treating Patients With Recurrent Glioblastoma or Anaplastic Astrocytoma
A Phase 2 study testing Laser Interstitial Thermal Therapy and Lomustine in people with IDH Family Wildtype and Recurrent Anaplastic Astrocytoma, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
This phase II trial studies how well laser interstitial thermal therapy and lomustine work in treating patients with glioblastoma or anaplastic astrocytoma that has come back. Using laser to heat the tumor cells may help to kill them. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- IDH Family Wildtype, Recurrent Anaplastic Astrocytoma, Recurrent Glioblastoma
- What is being tested?
- Laser Interstitial Thermal Therapy and Lomustine
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Nov 2017to 16 Feb 2021
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 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.
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- 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.
- White blood cell (WBC) > 3,000/ul (performed within 14 days (+ 3 working days) prior to registration)
- Absolute neutrophil count (ANC) > 1,500/mm^3 (performed within 14 days (+ 3 working days) prior to registration)
- Platelet count of > 100,000/mm^3 (may be reached by transfusion) (performed within 14 days (+ 3 working days) prior to registration)
- Hemoglobin > 10 gm/dl (may be reached by transfusion) (performed within 14 days (+ 3 working days) prior to registration)
- Serum glutamic-oxaloacetic transaminase (SGOT) and bilirubin < 2 times upper limit of normal (ULN) (performed within 14 days (+ 3 working days) prior to registration)
- Creatinine < 1.5 mg/dL (performed within 14 days (+ 3 working days) prior to registration)
- Women of childbearing potential must have a negative B-Human chorionic gonadotropin (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:
- A hysterectomy
- A bilateral oophorectomy
- A bilateral tubal ligation
- 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 < 40 pg/mL (< 140 pmol/L).
- 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.
- 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:
- 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
- Oral contraceptive, either combined or progestogen alone. A second barrier method is required during the first month of treatment with oral contraceptives
- Injectable progesterone
- Implants of levonorgestrel
- Estrogenic vaginal ring
- Percutaneous contraceptive patches
- Intrauterine device (IUD) or intrauterine system (IUS) with a documented failure rate of less than 1% per year
- 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
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase II Study of Laser Interstitial Thermal Therapy (LITT) in Recurrent Glioblastoma
This phase II trial studies how well laser interstitial thermal therapy and lomustine work in treating patients with glioblastoma or anaplastic astrocytoma that has come back. Using laser to heat the tumor cells may help to kill them. Drugs used in chemotherapy, such as lomustine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving laser interstitial thermal therapy and lomustine may work better in treating patients with glioblastoma or anaplastic astrocytoma.
Read the detailed description
PRIMARY OBJECTIVES:
- Determine the disease control rate at 6 months in patients with recurrent glioblastoma or isocitrate dehydrogenase (IDH)-wildtype anaplastic astrocytoma treated with Laser Interstitial Thermal Therapy (LITT) at recurrence, followed by salvage chemotherapy.
SECONDARY OBJECTIVES:
- Estimate overall survival (OS) of patients with recurrent glioblastoma, or isocitrate dehydrogenase (IDH)-wildtype anaplastic astrocytoma treated with LITT at tumor recurrence, followed by salvage chemotherapy.
II. Estimate time to progression (TTP) of patients with recurrent glioblastoma, or isocitrate dehydrogenase (IDH)-wildtype anaplastic astrocytoma that are treated with LITT at tumor recurrence, followed by salvage chemotherapy.
III. Analyze volumetric data consisting of thermal damage threshold lines and overall tumor volume to determine any role of 'extent of ablation' in outcomes (OS and/or TTP).
IV. Characterize the safety profile of LITT followed by treatment with lomustine chemotherapy in the recurrent disease setting, using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
- Assess the long-term steroid requirements following LITT, compared to historical controls.
VI. Determine the radiographic evolution of LITT-treated glioblastoma over time, using conventional magnetic resonance imaging (MRI) (T1 pre and post-contrast images, T2-weighted images [T2WI], fluid attenuating inversion recovery [FLAIR] images) and advanced brain tumor imaging (ABTI) [magnetic resonance (MR) perfusion [dynamic susceptibility contrast (DSC), dynamic contrast enhancement (DCE) and arterial spin labeling (ASL)], MR-diffusion, and MR spectroscopy), to include quantitative tumor metrics (volumetric extent of ablation and Response Assessment in Neuro-Oncology [RANO] criteria).
VII. Analyze health care utilization as measured by length of hospital stay following LITT (including inpatient rehabilitation care).
VIII. Evaluate patients' functional status (using the Karnofsky performance score [KPS] and the occurrence of symptoms [using the MD Anderson Symptom Inventory-Brain Tumor Module (MDASI-BT[English])] self-reporting tool), and correlate to disease progression and tolerance to treatment.
EXPLORATORY OBJECTIVES:
- Identify correlative tumor and peripheral blood molecular markers that impact outcomes, etc, and identify inflammatory/immunologic markers to assess neoantigen expression, etc, if sufficient tissue is available.
II. Identify and characterize changes in tumor tissue following LITT, by analyzing and comparing pre- and post-procedure tissue samples, if sufficient tissue is available.
OUTLINE:
Patients undergo LITT at baseline and receive lomustine orally (PO) on day 1. Treatment with lomustine repeats every 42 days for up to 6 cycles in the absence of disease progression or unaccepted toxicity.
After completion of study treatment, patients are followed up every 3 months.
- Being tested
- Laser Interstitial Thermal Therapy, Lomustine
- Medical subject headings
- Astrocytoma, Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laser Interstitial Thermal TherapyProcedure or surgery
Also called LITT
Undergo LITT
LomustineDrug
Also called 1-(2-Chloroethyl)-3-cyclohexyl-1-nitrosourea, 1-Nitrosourea, 1-(2-chloroethyl)-3-cyclohexyl-, Belustin, Belustine
Given PO
| Study group | Role | What they receive |
|---|---|---|
| Treatment (LITT, lomustine) | Experimental | Patients undergo LITT at baseline and receive lomustine PO on day 1. Treatment with lomustine repeats every 42 days for up to 6 cycles in the absence of disease progression or unaccepted toxicity. Receives: Procedure: Laser Interstitial Thermal Therapy; Drug: Lomustine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease Control Rate at 6 Months
Stable Disease per RANO occurs if the patient does not qualify for response or progression and requires stable non enhancing lesions, same/lower dose of corticosteroids, and clinical stability.
Complete Response per RANO requires complete disappearance of all enhancing measurable and nonmeasurable disease for at least 4 weeks; no new lesions; and stable/improved nonenhancing lesions, off corticosteroids (or on physiologic replacement dose) and clinical improvement/stability. Partial Response per RANO requires ≥50% decrease of enhancing lesions compared with baseline, sustained for at least 4 weeks; no progression of nonmeasurable disease; no new lesions; stable/improved nonenhancing lesions, same/lower dose of corticosteroids not greater than the dose at time of the baseline scan and clinically improved/stable.
Measured: At 6 months
Secondary outcomes (6)
Time to Progression (TTP)
Progression disease per the Response Assessment in Neuro-Oncology (RANO) is defined by any of the following: ≥25% increase in the sum of the products of perpendicular diameters of enhancing lesions (compared with baseline if no decrease) on stable or increasing doses of corticosteroids; a significant increase in T2/FLAIR nonenhancing lesions on stable or increasing doses of corticosteroids compared with the baseline scan or the best response after initiation of therapy, not due to comorbid events; the appearance of any new lesions; clear progression of nonmeasurable lesions; or definite clinical deterioration not attributable to other causes apart from the tumor or to a decrease in the corticosteroid dose.
Measured: From date of enrollment in study to the date of first observation of progressive disease, death due to disease (event), or early discontinuation of treatment, approximately 3 years 3 months
Long-term Steroid Requirements
Will be summarized by frequency tables.
Measured: Up to 4 years
MD Anderson Symptom Inventory-Brain Tumor Module (MDASI-BT) Data
Will summarize the MDASI-BT at each time point using descriptive statistics and evaluate the change of MDASI-BT over time and its correlation with response and/or treatment tolerance using linear mixed models, where random effects will be used to account for within-subject correlations.
Measured: at baseline, after procedure, and with every imaging visit thereafter, up to 4 years
Number of Participants With Incidence of Toxicity (Significant Hemorrhage or Brain Herniation) Documented on Imaging
Safety and toxicity of LITT by determination of adverse events and surgical complications within 2 weeks of the procedure, plus an additional 4 weeks (to account for potential delayed inflammatory changes and initiation of subsequent treatment). Safety for LITT procedure will be defined as the absence of severe clinical toxicity as determined by the CTCAE version 4.0, within 6 weeks of the procedure, and/or absence of acute events (ie, significant hemorrhage or brain herniation) documented on imaging. Severe toxicity will also be defined as a drop of 20 points or more in KPS and not amenable to corticosteroids, and likely attributable to the procedure, or symptomatic hemorrhage, increased brain edema resulting in herniation/impending herniation, and/or significant neurologic decline not amenable to corticosteroids. Safety and toxicity will be reassessed again throughout the duration of the study.
Measured: approximately 3 years 3 months
Overall Survival (OS)
Overall Survival (OS) is the time from initial tumor diagnosis (definitive surgical resection or biopsy) to death from any cause. Will be estimated using the Kaplan-Meier method and the comparison between or among patient's characteristic groups will be evaluated by log-rank test. The Cox regression model may be applied to assess the effect of covariates of interest on OS.
Measured: approximately 3 years 3 months
Length of Hospital Stay Following LITT
The length of hospital stay in days, weeks or months. Length of Hospital stay was summarized by using standard descriptive statistics, such as mean, standard deviation, median, and range for continuous variables, frequency and proportion for categorical variables.
Measured: approximately 3 years 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2017 (estimated)
- Study start7 Nov 2017
- Primary completion16 Feb 2021
- Study completion16 Feb 2021
Why it stopped: Slow accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for IDH Family WildtypeStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Barbara J O'Brien, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03022578
- Sponsor's protocol ID
- 2016-0443
- Other IDs
- NCI-2018-01286, 2016-0443, P30CA016672
- Status last verified
- Jul 2022
- First submitted
- 13 Jan 2017
- Last updated
- 10 Aug 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Laser Interstitial Thermal Therapy (LITT) in Recurrent Glioblastoma
- ClinicalTrials.gov ID
- NCT03022578
- Acronym / sponsor ID
- 2016-0443
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow accrual
- Enrolment
- 7 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 7 Nov 2017 (actual)
- Primary completion
- 16 Feb 2021 (actual)
- Study completion
- 16 Feb 2021 (actual)
- First posted
- 16 Jan 2017 (estimated)
- Results
- Posted 10 Aug 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This phase II trial studies how well laser interstitial thermal therapy and lomustine work in treating patients with glioblastoma or anaplastic astrocytoma that has come back. Using laser to heat the tumor cells may help to kill them. Drugs used in chemotherapy, such as lomustine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving laser interstitial thermal therapy and lomustine may work better in treating patients with glioblastoma or anaplastic astrocytoma.
Detailed description
PRIMARY OBJECTIVES:
- Determine the disease control rate at 6 months in patients with recurrent glioblastoma or isocitrate dehydrogenase (IDH)-wildtype anaplastic astrocytoma treated with Laser Interstitial Thermal Therapy (LITT) at recurrence, followed by salvage chemotherapy.
SECONDARY OBJECTIVES:
- Estimate overall survival (OS) of patients with recurrent glioblastoma, or isocitrate dehydrogenase (IDH)-wildtype anaplastic astrocytoma treated with LITT at tumor recurrence, followed by salvage chemotherapy.
II. Estimate time to progression (TTP) of patients with recurrent glioblastoma, or isocitrate dehydrogenase (IDH)-wildtype anaplastic astrocytoma that are treated with LITT at tumor recurrence, followed by salvage chemotherapy.
III. Analyze volumetric data consisting of thermal damage threshold lines and overall tumor volume to determine any role of 'extent of ablation' in outcomes (OS and/or TTP).
IV. Characterize the safety profile of LITT followed by treatment with lomustine chemotherapy in the recurrent disease setting, using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
- Assess the long-term steroid requirements following LITT, compared to historical controls.
VI. Determine the radiographic evolution of LITT-treated glioblastoma over time, using conventional magnetic resonance imaging (MRI) (T1 pre and post-contrast images, T2-weighted images [T2WI], fluid attenuating inversion recovery [FLAIR] images) and advanced brain tumor imaging (ABTI) [magnetic resonance (MR) perfusion [dynamic susceptibility contrast (DSC), dynamic contrast enhancement (DCE) and arterial spin labeling (ASL)], MR-diffusion, and MR spectroscopy), to include quantitative tumor metrics (volumetric extent of ablation and Response Assessment in Neuro-Oncology [RANO] criteria).
VII. Analyze health care utilization as measured by length of hospital stay following LITT (including inpatient rehabilitation care).
VIII. Evaluate patients' functional status (using the Karnofsky performance score [KPS] and the occurrence of symptoms [using the MD Anderson Symptom Inventory-Brain Tumor Module (MDASI-BT[English])] self-reporting tool), and correlate to disease progression and tolerance to treatment.
EXPLORATORY OBJECTIVES:
- Identify correlative tumor and peripheral blood molecular markers that impact outcomes, etc, and identify inflammatory/immunologic markers to assess neoantigen expression, etc, if sufficient tissue is available.
II. Identify and characterize changes in tumor tissue following LITT, by analyzing and comparing pre- and post-procedure tissue samples, if sufficient tissue is available.
OUTLINE:
Patients undergo LITT at baseline and receive lomustine orally (PO) on day 1. Treatment with lomustine repeats every 42 days for up to 6 cycles in the absence of disease progression or unaccepted toxicity.
After completion of study treatment, patients are followed up every 3 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (LITT, lomustine) | Experimental | Procedure: Laser Interstitial Thermal Therapy, Drug: LomustinePatients undergo LITT at baseline and receive lomustine PO on day 1. Treatment with lomustine repeats every 42 days for up to 6 cycles in the absence of disease progression or unaccepted toxicity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (30 listed)
- 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 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).
Key exclusion criteria (11 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laser Interstitial Thermal TherapyAlso: LITTUndergo LITT | Procedure or surgery | Treatment (LITT, lomustine) |
| LomustineAlso: 1-(2-Chloroethyl)-3-cyclohexyl-1-nitrosourea, 1-Nitrosourea, 1-(2-chloroethyl)-3-cyclohexyl-, Belustin, BelustineGiven PO | Drug | Treatment (LITT, lomustine) |
Primary outcome
Disease Control Rate at 6 Months
Time frame: At 6 months
Stable Disease per RANO occurs if the patient does not qualify for response or progression and requires stable non enhancing lesions, same/lower dose of corticosteroids, and clinical stability. Complete Response per RANO requires complete disappearance of all enhancing measurable and nonmeasurable disease for at least 4 weeks; no new lesions; and stable/improved nonenhancing lesions, off corticosteroids (or on physiologic replacement dose) and clinical improvement/stability. Partial Response per RANO requires ≥50% decrease of enhancing lesions compared with baseline, sustained for at least 4 weeks; no progression of nonmeasurable disease; no new lesions; stable/improved nonenhancing lesions, same/lower dose of corticosteroids not greater than the dose at time of the baseline scan and clinically improved/stable.
6 secondary outcomes
Time to Progression (TTP)
Time frame: From date of enrollment in study to the date of first observation of progressive disease, death due to disease (event), or early discontinuation of treatment, approximately 3 years 3 months
Long-term Steroid Requirements
Time frame: Up to 4 years
MD Anderson Symptom Inventory-Brain Tumor Module (MDASI-BT) Data
Time frame: at baseline, after procedure, and with every imaging visit thereafter, up to 4 years
Number of Participants With Incidence of Toxicity (Significant Hemorrhage or Brain Herniation) Documented on Imaging
Time frame: approximately 3 years 3 months
Overall Survival (OS)
Time frame: approximately 3 years 3 months
Length of Hospital Stay Following LITT
Time frame: approximately 3 years 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Barbara J O'Brien principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Laser Interstitial Thermal Therapy and Lomustine in people with IDH Family Wildtype and Recurrent Anaplastic Astrocytoma, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 30 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 10 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Aug 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease Control Rate at 6 Months (time frame: At 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2022.