90 Participants Needed

L19TNF + Lomustine for Glioblastoma

(GLIOSTELLA Trial)

Recruiting at 7 trial locations
TH
MT
Overseen ByMarco Taras
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

The trial aims to collect safety, efficacy, exposure, dose- response, pharmacokinetic and pharmacodynamic information of the combination of L19TNF and lomustine at different dose levels in patients with Glioblastoma at progression or recurrence

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, you cannot have had anti-cancer treatments, certain investigational drugs, or specific medications like high-dose corticosteroids within a certain period before starting the trial. It's best to discuss your current medications with the trial team.

Is the combination of L19TNF and Lomustine safe for humans?

Lomustine, a part of the treatment, can cause lung issues like pulmonary fibrosis (scarring of lung tissue) and hematotoxicity (blood-related side effects). These side effects have been observed in treatments for brain tumors, indicating potential safety concerns.12345

What makes the drug L19TNF + Lomustine unique for treating glioblastoma?

The combination of L19TNF and Lomustine is unique because it pairs a targeted therapy (L19TNF) with a chemotherapy agent (Lomustine), potentially enhancing the treatment's effectiveness against glioblastoma by targeting tumor blood vessels and cancer cells simultaneously. This approach differs from standard treatments that typically involve surgery, radiation, and temozolomide chemotherapy.12678

What data supports the effectiveness of the drug L19TNF + Lomustine for Glioblastoma?

Research shows that lomustine, a component of the treatment, is effective in treating high-grade gliomas and glioblastoma, especially when combined with other drugs like temozolomide, as it improved overall survival in certain trials. However, the effectiveness of L19TNF specifically for glioblastoma is not directly addressed in the available research.126910

Are You a Good Fit for This Trial?

This trial is for adults over 18 with confirmed glioblastoma that has progressed or recurred. They must have a Karnofsky Performance Status of at least 60%, known MGMT promoter status, and no HIV, HBV, or HCV infections. Women must not be able to bear children or use effective contraception; men also need to agree to use contraception.

Inclusion Criteria

My glioblastoma diagnosis is confirmed and has progressed.
I know my cancer's MGMT promoter status.
My recent surgery confirmed glioblastoma recurrence, and I will have an MRI 3-5 weeks after, with treatment starting 4 weeks post-surgery.
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive L19TNF and lomustine in a 42-day cycle for up to 6 cycles

36 weeks
6 cycles with multiple visits per cycle

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

What Are the Treatments Tested in This Trial?

Interventions

  • L19TNF
  • Lomustine
Trial Overview The study tests the combination of L19TNF and lomustine in various doses on patients with recurrent or progressing glioblastoma. It aims to assess safety, effectiveness, how the body processes the drugs (pharmacokinetics), and their impact on the disease (pharmacodynamics).
How Is the Trial Designed?
6Treatment groups
Experimental Treatment
Group I: Arm FExperimental Treatment2 Interventions
Group II: Arm EExperimental Treatment2 Interventions
Group III: Arm DExperimental Treatment2 Interventions
Group IV: Arm CExperimental Treatment2 Interventions
Group V: Arm BExperimental Treatment2 Interventions
Group VI: Arm AExperimental Treatment2 Interventions

L19TNF is already approved in European Union for the following indications:

🇪🇺
Approved in European Union as Onfekafusp alfa for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Philogen S.p.A.

Lead Sponsor

Trials
42
Recruited
2,400+

Published Research Related to This Trial

Nitrosoureas, such as lomustine, carmustine, and fotemustine, are among the most effective treatments for high-grade gliomas and glioblastoma, highlighting their importance in cancer therapy.
Due to their toxicity and the introduction of temozolomide, nitrosoureas are now primarily used for recurrent cases of gliomas, indicating a shift in their clinical application.
Nitrosoureas in the Management of Malignant Gliomas.Brandes, AA., Bartolotti, M., Tosoni, A., et al.[2018]
In the CeTeG/NOA-09 trial, the combination of lomustine and temozolomide (CCNU/TMZ) showed superior overall survival compared to temozolomide alone in patients with MGMT promoter-methylated glioblastoma, although progression-free survival rates were similar between the two treatments.
Analysis of MRI features at progression revealed that patients treated with CCNU/TMZ who had long postprogression survival exhibited a significant increase in mean ADC values, suggesting potential pseudoprogression, which may not have been detected by standard mRANO criteria.
Undetected pseudoprogressions in the CeTeG/NOA-09 trial: hints from postprogression survival and MRI analyses.Zeyen, T., Paech, D., Weller, J., et al.[2023]
Fotemustine is an alkylating agent that has shown an objective response rate of 26% to 70% in treating recurrent malignant gliomas, with a reported median survival time of about 10 months.
Common side effects of fotemustine include myelosuppression, leucopenia, and thrombocytopenia, and it is currently used in Europe as a salvage therapy, often in combination with angiogenesis inhibitors like bevacizumab.
Fotemustine: a third-generation nitrosourea for the treatment of recurrent malignant gliomas.Beauchesne, P.[2021]

Citations

Nitrosoureas in the Management of Malignant Gliomas. [2018]
Undetected pseudoprogressions in the CeTeG/NOA-09 trial: hints from postprogression survival and MRI analyses. [2023]
Fotemustine: a third-generation nitrosourea for the treatment of recurrent malignant gliomas. [2021]
Patterns, predictors and prognostic relevance of high-grade hematotoxicity after temozolomide or temozolomide-lomustine in the CeTeG/NOA-09 trial. [2023]
The Efficacy and Safety of Adjuvant Lomustine to Chemotherapy for Recurrent Glioblastoma: A Meta-analysis of Randomized Controlled Studies. [2022]
[A multicenter randomized controlled study of temozolomide in 97 patients with malignant brain glioma]. [2018]
Restrictive lung disease following treatment for malignant brain tumors: a potential late effect of craniospinal irradiation. [2017]
Lung toxicity of lomustine in the treatment of progressive gliomas. [2022]
How did lomustine become standard of care in recurrent glioblastoma? [2020]
Palliative therapy of melanoma patients with fotemustine. Inverse relationship between tumour load and treatment effectiveness. A multicentre phase II trial of the EORTC-Melanoma Cooperative Group (MCG). [2019]
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