LITT + Lomustine for Glioblastoma

Overseen By Orwa Aboud, MD, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: University of California, Davis

Must not be taking: Nitrosoureas, Polifeprosan 20, Bevacizumab, others

Disqualifiers: Pregnancy, Uncontrolled illness, Recent hemorrhage, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new approach for treating glioblastoma, a type of brain cancer that has returned after treatment. Researchers aim to determine if using laser interstitial thermal therapy (LITT) followed by lomustine (a chemotherapy medication) is safe and feasible. They are also examining how this treatment might affect survival rates over two years. Eligible participants should have confirmed glioblastoma that has worsened after prior treatments and be able to swallow oral medication. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this innovative approach.

Will I have to stop taking my current medications?

Participants must stop taking other cytotoxic and non-cytotoxic drug therapies for glioblastoma while enrolled in the study. There are specific timeframes for stopping certain medications before joining the trial, such as four weeks for cytotoxic agents and two weeks for non-cytotoxic agents. However, some medications like anticoagulants and NSAIDs are allowed.

What prior data suggests that this combination of LITT and lomustine is safe for treating glioblastoma?

A previous study found laser interstitial thermal therapy (LITT) to be a promising option for treating glioblastoma, a type of brain cancer. It successfully shrank tumors in over 94% of cases. However, LITT carries some risks, such as bleeding, brain swelling, and infection at the procedure site.

Lomustine, a chemotherapy drug, is already widely used for glioblastoma. Its side effects are well-known, with common ones including tiredness and issues with blood cells, though serious problems are rare.

In summary, both LITT and lomustine are generally considered safe, with their risks well understood. This makes them promising options for further research in clinical trials. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about the combination of Laser Interstitial Thermal Therapy (LITT) and Lomustine for glioblastoma because it offers a unique approach compared to existing treatments like surgery, radiation, and chemotherapy. LITT uses precise lasers to target and destroy tumor cells, which could minimize damage to surrounding healthy brain tissue. When combined with Lomustine, a chemotherapy drug known for its ability to cross the blood-brain barrier, this treatment has the potential to enhance the destruction of cancer cells more effectively. This novel method might improve outcomes by attacking the tumor both physically and chemically, offering hope for better management of this aggressive brain cancer.

What evidence suggests that LITT + lomustine could be effective for glioblastoma?

This trial will evaluate the combination of Laser Interstitial Thermal Therapy (LITT) and Lomustine for glioblastoma. Research has shown that LITT is a promising treatment for glioblastoma, especially when surgery isn't possible. Studies indicate that LITT can help patients live longer without cancer progression (progression-free survival) and can extend overall survival, with an average of about 10.2 months. It also effectively shrinks tumors in most patients.

Lomustine is a common treatment for glioblastoma and works well, especially for tumors with a specific genetic marker (MGMT promoter-methylated). It is often used when the cancer returns after initial treatments. This trial will explore whether combining LITT and Lomustine offers a hopeful option for those with recurring glioblastoma. ^{1 2 3 4 5}

Who Is on the Research Team?

Orwa Aboud, MD, PhD

Principal Investigator

University of California, Davis

Are You a Good Fit for This Trial?

Adults with recurrent glioblastoma, a type of brain cancer, are eligible for this trial. Participants must be able to undergo the laser therapy and take lomustine afterward within the specified timeframe. Specific inclusion and exclusion criteria details were not provided.

Inclusion Criteria

I can take pills by mouth.

I agree not to take other drugs for glioblastoma during the study.

I've had surgery for a returning tumor and have recovered.

Exclusion Criteria

I have not had major surgery or a significant injury in the last 28 days.

Patients who have received any investigational agents ≤ 4 weeks or 5 drug half-lives (whichever is shorter) prior to commencing study treatment.

Evidence of recent hemorrhage on baseline MRI of the brain with specific exceptions.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Laser Interstitial Thermal Therapy (LITT)

LITT procedure performed under general anesthesia using a stereotactic neurosurgical approach with MRI guidance

1 day

1 visit (in-person)

Lomustine Administration

Lomustine administered approximately 7 days following LITT

1 day

1 visit (in-person)

Follow-up

Participants are monitored for serious and non-serious adverse events and overall survival

Up to 2 years

What Are the Treatments Tested in This Trial?

Interventions

• Laser Interstitial Thermal Therapy
• Lomustine

Trial Overview The study is testing the combination of Laser Interstitial Thermal Therapy (LITT) followed by chemotherapy drug Lomustine (CCNU). It's a phase 1 trial focusing on safety and feasibility, with an additional goal to track overall survival rates for up to two years post-treatment.

How Is the Trial Designed?

Group I: Laser interstitial thermal therapy (LITT) + Lomustine (CCNU) Experimental Treatment 2 Interventions

Laser interstitial thermal therapy (LITT) + Lomustine (CCNU)

Who Is Running the Clinical Trial?

University of California, Davis

Lead Sponsor

Trials

958

Recruited

4,816,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39528836/

Evaluating efficacy and safety of laser interstitial thermal ... LITT shows promise for treating both newly diagnosed and recurrent GB cases in non-surgical candidates, linked to improved OS, PFS, reduced tumor volume, and ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05318612

NCT05318612 | Effectiveness of MR-guided LITT Therapy ... The aim of this study is to investigate the (cost-)effectiveness of LITT (Laser Interstitial Thermal Therapy) in primary irresectable glioblastoma.

3. thejns.org thejns.org/focus/view/journals/neurosurg-focus/57/5/article-pE4.xml

An analysis of functional outcomes following laser interstitial ... The majority of patients undergoing LITT for recurrent HGG had a favorable functional outcome at the initial follow-up visit. The treated tumor volume was ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0303846720302857

Survival outcomes in patients with recurrent glioblastoma ... The median progression-free survival and the median overall survival after laser interstitial thermal therapy resulted 5.6 months and 10.2 months, respectively.

5. mdpi.com mdpi.com/2072-6694/16/11/2131

Safety and Efficacy of Laser Interstitial Thermal Therapy as ... The pooled data suggest LITT may be a safe primary management option with tumor ablation rates of 94.8% and 84.6% in IDH-wildtype glioblastoma ...