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New treatment option for Glioblastoma
Official title Laser Interstitial Thermal Therapy (LITT) and Lomustine (CCNU) for Recurrent Glioblastoma
ClinicalTrials.gov ID: NCT07145112
What this study is testing
What is Lomustine?
Lomustine is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for glioblastoma.
Also referred to as CCNU, Gleostine.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a phase 1 study evaluating the safety and feasibility of laser interstitial thermal therapy (LITT) followed by lomustine (CCNU) for recurrent glioblastoma in adults. The primary aim is to evaluate the safety of the combination of LITT plus lomustine based on the assessment of treatment-related adverse events and the feasibility of completing LITT + lomustine in the proposed timeframe.
- Phase 1: an early, usually small safety study
- Time commitment: about 2 years
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Histologically confirmed World Health Organization (WHO) 2021 defined glioblastoma. A pathology report constitutes adequate documentation of...
- Radiographic demonstration of disease progression following prior therapy.
- Patients having undergone recent resection of recurrent or progressive tumor will be eligible as long as the patient has recovered from surgery...
- Prior standard radiation for glioblastoma (short course 40 Gy, standard 60 Gy, and proton therapy are allowed).
- Patients must have recovered from the effects of prior therapy.
You likely can't join if
- Patients who are not surgical candidates for stereotactic biopsy or laser ablation.
- Prior treatment with nitrosourea agents (e.g. lomustine [CCNU], carmustine [BCNU], nimustine [ACNU]).
- Prior treatment with polifeprosan 20 with carmustine wafer.
- Prior treatment with bevacizumab.
- 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 the following exceptions: (1) presence of hemosiderin, (2) resolving hemorrhagic...
See the full eligibility criteria
- Histologically confirmed World Health Organization (WHO) 2021 defined glioblastoma. A pathology report constitutes adequate documentation of histology for study inclusion.
- Radiographic demonstration of disease progression following prior therapy.
- Patients having undergone recent resection of recurrent or progressive tumor will be eligible as long as the patient has recovered from surgery. Evaluable or measurable disease following resection of recurrent tumor is...
- Prior standard radiation for glioblastoma (short course 40 Gy, standard 60 Gy, and proton therapy are allowed).
- Patients must have recovered from the effects of prior therapy.
- The following listed agents/interventions must have been discontinued for their respective time period prior to enrollment:
- Four weeks from cytotoxic agents (3 weeks from procarbazine, 3 weeks from vincristine, and 4 weeks from temozolomide);
- Four weeks or 5 drug half-lives (whichever is shorter) from any investigational agent; two weeks or 5 drug half-lives (whichever is shorter) from non-cytotoxic agents (e.g. Accutane, thalidomide);
- Twelve weeks from radiotherapy to minimize the potential for MRI changes related to radiation necrosis that might be misdiagnosed as progressive disease, or 4 weeks if a new lesion, relative to the pre-radiation MRI...
- Patients must have the following laboratory parameters ≤ 14 days prior to registration: a. adequate bone marrow function defined by: i. white blood cells (WBC) ≥ 3 × 109/L , ii. absolute neutrophil count (ANC) ≥ 1.5 ×...
- Karnofsky performance status (KPS) ≥ 50 (see Appendix).
- Individuals of childbearing potential or those with partners of childbearing potential must agree to use adequate methods of contraception for the duration of study participation (including dosing interruptions) and for...
- Patients on the following medications are allowed:
- Anticoagulants: Patients on stable dose anticoagulants (e.g. warfarin in-range international normalized ratio [INR], low molecular-weight heparin)
- Patients are allowed to take aspirin, clopidogrel, ticlopidine, Aggrenox, ibuprofen and other NSAIDS.
- Patients must be willing to forego other cytotoxic and non-cytotoxic drug therapy for glioblastoma while enrolled in the study.
- Able to swallow oral medication.
- Patients ≥18 years of age at time of consent.
- Ability to understand and willingness to sign an informed consent form (ICF).
- Ability and stated willingness to adhere to the study visit schedule and protocol procedures/requirements, including periodic blood sampling and study related assessments
- Patients who are not surgical candidates for stereotactic biopsy or laser ablation.
- Prior treatment with nitrosourea agents (e.g. lomustine [CCNU], carmustine [BCNU], nimustine [ACNU]).
- Prior treatment with polifeprosan 20 with carmustine wafer.
- Prior treatment with bevacizumab.
- 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 the following exceptions: (1) presence of hemosiderin, (2) resolving hemorrhagic changes related to surgery, or (3) presence of punctate hemorrhage in the...
- History of intracerebral abscess within 6 months prior to Day 1.
- Major surgical procedure, open biopsy, or significant traumatic injury ≤ 28 days prior to Day 1, or anticipation of the need for a major surgical procedure during the course of the study.
- Serious non-healing wound, ulcer, or bone fracture.
- Pregnancy (positive pregnancy test) or lactation.
- Known hypersensitivity to any component of lomustine (CCNU).
- Uncontrolled intercurrent illness or unstable systemic disease, including, but not limited to, ongoing or active infection, uncontrolled hypertension, or serious cardiac arrhythmia requiring medication that would...
- Unable to undergo an MRI with contrast.
- Known allergy to nitrosoureas (e.g., lomustine, carmustine, nimustine).
- Any condition that in the opinion of the investigator would interfere with the participant's safety or compliance while on trial
The study team makes the final eligibility decision.
Where it's taking place
- Sacramento, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 2 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Sacramento, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.