Status:
COMPLETED
Anticancer Therapeutic Vaccination Using Telomerase-derived Universal Cancer Peptides in Glioblastoma
Lead Sponsor:
Centre Hospitalier Universitaire de Besancon
Conditions:
Glioblastoma
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
Glioblastoma (GBM) is the most frequent primary brain tumor and the brain tumor with the poorest prognosis. The current treatment relies on surgical resection of gross tumor followed by radiochemother...
Eligibility Criteria
Inclusion
- Male or female patients, age ≥ 18 and ≤ 75 years old
- Written informed consent
- Histologically confirmed glioblastoma
- Patient with known MGMT status:
- Cohort A (recruitment closed) : unmethylated MGMT status ; Cohort B (recruiting) : unmethylated or methylated MGMT status
- Patients previously pre-treated with standard radiochemotherapy (without the additional cures of temozolomide.)
- Karnofsky Performance status ≥ 70%
- Life-expectancy \> 3 months
- Adequate hematological, hepatic, and renal function.
- Females must be using highly effective contraceptive measures , and have a negative pregnancy test prior to the start of dosing if of childbearing potential, or must have evidence of non-childbearing potential.
- Females of childbearing potential should use reliable methods of contraception from the time of the screening until 5 weeks after discontinuing study treatment.
- Male patients with a female partner of childbearing potential should be willing to use barrier contraception during the study and for 5 months following discontinuation of study drug. Patients should refrain from donating sperm from the start of dosing until 5 months after discontinuing study treatment.
- \- Affiliation to French social security or receiving such a regime.
Exclusion
- Presence of known extracranial metastatic or leptomeningeal disease Glioblastoma with mutated IDH1 (assessed by Immunohistochemistry)
- Current or recent treatment with another investigational drug
- Carmustine implant during surgery
- History of autoimmune diseases (lupus, rheumatoid arthritis, inflammatory bowel disease…)
- Prohibited medications:
- Chronic treatment with immunosuppressive drugs
- Ongoing requirement for supraphysiologic steroid defined as \>10 mg prednisone daily (or equivalent)
- Treatment with therapeutic oral or IV antibiotics within 4 weeks prior to enrollment. Patients receiving prophylactic antibiotics (e.g., to prevent a urinary tract infection or pulmonary disease) are eligible for the study
- Known positive serology for Human Immunodeficiency Virus (HIV) or Hepatitis C virus (HCV); presence in the serum of the antigens HBs
- Non-hematologic toxicities Grade \>1 severity (or, at the investigator's discretion, Grade \>2 if not considered a safety risk for the patient).
- Patient with intra-alveolar hemorrhage, pulmonary fibrosis, or uncontrolled asthma, or chronic obstructive disease (COPD), defined as at least 1 hospitalization within 4 months prior to enrollment or as at least 3 exacerbations during the last year prior to enrollment Hospitalization for cardiovascular or pulmonary disease within 4 weeks prior to enrollment.
- Patients with LEVF\<40%
- Participation in a clinical study with an investigational product within 4 weeks prior to the start of the study treatment or patient in the exclusion period of a previous clinical trial.
- Pregnancy or lactating patients.
- Patients with any severe/uncontrolled inter current illness, significant co morbid or psychiatric conditions that in the opinion of the investigator would impair study participation or cooperation.
- Patients under guardianship, curatorship or under the protection of justice.
Key Trial Info
Start Date :
May 26 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2024
Estimated Enrollment :
67 Patients enrolled
Trial Details
Trial ID
NCT04280848
Start Date
May 26 2020
End Date
December 31 2024
Last Update
January 9 2025
Active Locations (5)
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1
CHU Besançon
Besançon, France
2
CHU Bordeaux
Bordeaux, France
3
Centre Georges François Leclerc
Dijon, France
4
CHU La Timone
Marseille, France