Study on L19TNF and Lomustine for Patients with Glioblastoma at Progression or Recurrence
Sponsor: Philogen S.p.A.
ClinicalTrials ID:NCT06336291
This clinical trial is testing a combination of two drugs, L19TNF and lomustine, to see if they can help treat glioblastoma that has come back or is getting worse. The study will look at different doses to find the best treatment plan.
Patient Parameters
| Parameter | Options |
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Program Overview
The purpose of this study is to gather information on the safety and effectiveness of combining L19TNF with lomustine in patients whose glioblastoma has returned or is progressing. Researchers will test different doses to find the best combination that works well and has the fewest side effects.
Description
This study involves 90 patients with glioblastoma that has returned or is getting worse. Participants will be randomly assigned to one of six treatment groups, each receiving different doses of L19TNF and lomustine. The treatment will be given in cycles lasting 42 days, for up to six cycles.
The main goal is to find the best dose combination that is effective and has the least side effects. Researchers will monitor safety by checking for any adverse events, serious side effects, and changes in liver function. They will also evaluate how well the treatment works by looking at survival rates after 12 months.
A Data and Safety Monitoring Board will regularly review safety information to ensure patient safety. If a treatment group shows a high risk of severe side effects, recruitment for that group may be paused or stopped.
In case of a treatment-related death, all treatment groups will be paused until a thorough review is conducted.
Eligibility Criteria
Inclusion Criteria
- Adults aged 18 or older.
- Diagnosed with glioblastoma that is progressing or has returned.
- If surgery was performed, a new MRI is needed 3-5 weeks after surgery, and treatment must start at least 4 weeks post-surgery.
- Known MGMT promoter status.
- Karnofsky Performance Status of 60% or higher.
- Negative tests for HIV, HBV, and HCV, with specific conditions for past HBV exposure.
- Women must not be pregnant and must use effective contraception if of childbearing potential.
- Men must use two forms of contraception if they can father children.
- Signed informed consent and willingness to follow study procedures.
Exclusion Criteria
- Cannot undergo contrast-enhanced MRI.
- Recent anti-cancer treatments within 4 weeks before starting the study.
- Participation in another drug or device study within 4 weeks before starting the study.
- Severe blood cell count issues from previous treatments.
- Previous treatment with Bevacizumab or L19TNF.
- Known allergies to study drugs or similar medications.
- Poor kidney or liver function.
- Severe heart conditions or recent heart issues.
- Uncontrolled high blood pressure.
- Active infections or other severe health conditions.
- Recent major surgery or trauma.
- Pregnant or breastfeeding women.
- Need for high-dose steroids or immunosuppressants.
- Recent live vaccinations within 4 weeks before starting the study.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Northwestern Memorial Hospital | 60611 | Chicago | Illinois |
| Massachusetts General Hospital (MGH) | 02114 | Boston | Massachusetts |
| Beth Israel Deaconess Medical Center (BIDMC) | 02215 | Boston | Massachusetts |
| Dana-Farber Cancer Institute (DFCI) | 02215 | Boston | Massachusetts |
| Memorial Sloan Kettering Cancer Center | 10065 | New York | New York |
| Abramson Cancer Center of the University of Pennsylvania | 19104 | Philadelphia | Pennsylvania |
| UPMC Hillman Cancer Center | 15232 | Pittsburgh | Pennsylvania |
| University of Virginia (UVA) | 22903 | Charlottesville | Virginia |
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