Procedure: LITT for Glioblastoma

Phase-Based Estimates
1
Effectiveness
1
Safety
UCH Kaufman Cancer Center, Bel Air, MD
Glioblastoma+4 More
Procedure: LITT - Device
Eligibility
18+
All Sexes
Eligible conditions
Glioblastoma

Study Summary

This study is evaluating whether a combination of radiation and laser therapy may help treat recurrent gliomas.

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Eligible Conditions

  • Glioblastoma
  • Cancer
  • Glioma
  • Brain Cancer
  • Neoplasms
  • Brain Neoplasms
  • Neoplasms, Brain

Treatment Effectiveness

Study Objectives

This trial is evaluating whether Procedure: LITT will improve 1 primary outcome and 6 secondary outcomes in patients with Glioblastoma. Measurement will happen over the course of 2 Years.

2 Years
Median progression-free survival
Progression-free survival at 6 months
2 years
1-year overall survival
Adverse Events
Median overall survival
Overall response rate
Quality of Life before, during, and after treatment

Trial Safety

Trial Design

2 Treatment Groups

Control
Experimental: LITT with Hypofractionated radiation therapy

This trial requires 32 total participants across 2 different treatment groups

This trial involves 2 different treatments. Procedure: LITT is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Experimental: LITT with Hypofractionated radiation therapyLaser interstitial thermal therapy (LITT) followed by hypo-fractionated radiation therapy, 35Gy/10 fractions.
ControlNo treatment in the control group

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 2 years
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 2 years for reporting.

Who is running the study

Principal Investigator
D. o. R. O.
Department of Radiation Oncology, Principal Investigator
University of Maryland, Baltimore

Closest Location

UCH Kaufman Cancer Center - Bel Air, MD

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. You must have received newly diagnosed for Glioblastoma or one of the other 4 conditions listed above. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Patients will only receive re-irradiation if pathology from LITT is consistent with recurrent tumor Patients must have signed an approved informed consent
Patients with the potential for pregnancy or impregnating their partner must agree to practice effective contraceptive methods to avoid conception while on study and for 6 months after study completion.
Patients with history of a WHO Grade II-IV glioma with radiographic evidence of recurrent or progressive tumor Patient must have received prior radiation therapy for initial treatment of glioma
Patients with any number of recurrences are allowed as long as the patient has not undergone re-irradiation
Brain MRI with contrast demonstrates an enhancing tumor ≤ 6 cm in largest diameter within 60 days prior to registration
History and physical including neurological exam within 30 days prior to registration
Karnofsky performance status ≥ 60% within 30 days prior to registration
Age ≥ 22 years old
Minimum interval since completion of prior radiation treatment is 8 weeks
Female patients of child-bearing potential must have a negative pregnancy test within 28 days prior to study registration.

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can glioblastoma be cured?

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There is some evidence that adjuvant chemoradiation is effective in reducing recurrence of glioblastoma. However, a cure for this cancer is not in the near future.

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What are common treatments for glioblastoma?

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Treatments for glioblastoma are multifactorial and do not use the same principles all the time. Treatments are used on the basis of the type or location of the tumor, the age and health of the patient (the “risk-benefit ratio”), the treatment's side effects, the person's desires and fears about treatment choices, and other factors. The treatments vary by the type, location, and stage of this tumor. Many of the treatment options have been developed since 1950, when the first chemotherapy drugs were formulated. The newer therapy options include targeted therapies and other innovative approaches.

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What are the signs of glioblastoma?

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The signs of glioblastoma begin before a person is affected with symptoms of the disease. The following symptoms are common.\n- Loss of coordination with walking.\n- Visual disturbances.\n- Visual complaints about ringing in the ears.\n- Headache.\n- Seizures.\n- Weakness.\n- Dizziness.\n- Confusion.\n- Memory loss.\n- A persistent, dull pain in the limbs.

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What causes glioblastoma?

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The cause of glioblastoma is not clear and is likely related to a combination of factors such as the environmental exposures which have a significant effect on tumour susceptibility in genetically susceptible individuals, and on tumour development and progression following exposure to these environmental exposures; genetics, epigenetics - DNA alterations which occur in glioblastoma during tumorigenesis; and brain injury, especially in the periventricular nodule of the primitive telencephalon.

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What is glioblastoma?

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The majority of the glioblastoma tumor is glial in nature and is an invasive tumor with fast growth rates. Survival after glioblastoma surgery has improved over the last few decades. The current study is intended to provide an updated review of the use of bevacizumab as a second-line agent in glioblastoma. For glioblastoma patients who receive bevacizumab, a trend for improved overall survival was observed. However, an increased risk of serious adverse events was observed. If confirmed in future studies, these findings may limit the use of bevacizumab in the glioblastoma patient population.

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How many people get glioblastoma a year in the United States?

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Fewer than 10,000 cases are diagnosed each year with glioblastoma in the United States. More research is needed to identify risk factors for the disease, to improve the diagnosis and management of patients with the condition, and to identify ways of improving the long-term survival of patients with glioblastoma.

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How quickly does glioblastoma spread?

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Results from a recent clinical trial suggests an increase in the rate of metastases to distant sites during times of greater tumour diameter growth, a trend found previously with tumours in other sites such as prostate and breast. Furthermore, more rapid rates of growth and metastatic spread were found to be associated with longer duration of clinical control before diagnosis and with progression-free survival in overall and OSA/PDS, but not in OS.

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How does procedure: litt work?

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In conclusion, according to surgeon and in our personal experience, we believe that litt surgery should be performed only in selected patients with a good-quality life expectancy. If surgery is indicated it will allow the patients to have a longer life with fewer symptoms - even in the case in which the tumor is located in an eloquent brain area.

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What is the latest research for glioblastoma?

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Recent studies, in which the authors have participated, have mostly evaluated adjuvant therapy using temozolomide alone, which may be a viable option. In a recent article, a study done as a randomized design was mentioned. There's a phase II study using the same regimen as the phase I study\n

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What is the survival rate for glioblastoma?

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The median survival time from diagnosis of glioblastoma is approximately 12 months and survival remains dismal. This may be due to the extent of maximal surgical removal and/or the presence of diffuse disease. We would recommend that most patients with glioblastomas should have a total surgical excision with maximal surgical removal and adjuvant chemotherapy. There are many factors related to the survival outcome including age, gender, extent of resection, tumor burden, degree of neuropathic component, grade, and resected hemisphere and hemisphere involvement. Survival for glioblastoma is worse than that for the malignant glioma of other types.

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Does procedure: litt improve quality of life for those with glioblastoma?

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Our studies show no significant difference in the QoL for the 2 surgical procedures performed, though there is a trend for patients undergoing craniotomy to have better overall QoL. Patients who undergo craniotomy reported a higher frequency of vomiting and nausea, regardless of the surgery procedure performed and type of adjuvant therapy (conventional chemotherapy or multimodality therapy of radiation therapy and chemotherapy) received.

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Is procedure: litt safe for people?

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The majority of patients prefer this operation than a traditional craniotomy. Even though this operation requires a longer time until the mobilization of the patient and of the cranial vault, then there is no significant difference in the quality of the neurological outcome.

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