Clinical Trials /

Anticancer Therapeutic Vaccination Using Telomerase-derived Universal Cancer Peptides in Glioblastoma

NCT04280848

Description:

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 radiochemotherapy and adjuvant therapy with temozolomide. After such therapy, most patients experiment recurrence and few therapeutic option are available. Despite such therapies, median survival only reaches around fifteen months. There is a strong rational to develop telomerase vaccine in GBM. Telomerase (TERT) is a major oncogene, particularly in primary brain tumors 24. Alterations in TERT are very frequent in central nervous system tumors, seen most commonly in gliomas25. Mutations in the TERT promoter are found in approximately 80% of primary glioblastoma (GBM). These findings strongly support the rational to develop vaccine targeting telomerase in GBM. The aim of this project is to evaluate UCPVax treatment in glioblastoma. UCPVax is a therapeutic anti-cancer vaccine based on the telomerase-derived helper peptides designed to induce strong TH1 CD4 T cell responses in cancer patients (NCT02818426).

Related Conditions:
  • Glioblastoma
Recruiting Status:

Recruiting

Phase:

Phase 1/Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Anticancer Therapeutic Vaccination Using Telomerase-derived Universal Cancer Peptides in Glioblastoma
  • Official Title: Anticancer Therapeutic Vaccination Using Telomerase-derived Universal Cancer Peptides in Glioblastoma

Clinical Trial IDs

  • ORG STUDY ID: N/2013/67
  • NCT ID: NCT04280848

Conditions

  • Glioblastoma

Interventions

DrugSynonymsArms
UCPVaxUCPVax vaccine

Purpose

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 radiochemotherapy and adjuvant therapy with temozolomide. After such therapy, most patients experiment recurrence and few therapeutic option are available. Despite such therapies, median survival only reaches around fifteen months. There is a strong rational to develop telomerase vaccine in GBM. Telomerase (TERT) is a major oncogene, particularly in primary brain tumors 24. Alterations in TERT are very frequent in central nervous system tumors, seen most commonly in gliomas25. Mutations in the TERT promoter are found in approximately 80% of primary glioblastoma (GBM). These findings strongly support the rational to develop vaccine targeting telomerase in GBM. The aim of this project is to evaluate UCPVax treatment in glioblastoma. UCPVax is a therapeutic anti-cancer vaccine based on the telomerase-derived helper peptides designed to induce strong TH1 CD4 T cell responses in cancer patients (NCT02818426).

Trial Arms

NameTypeDescriptionInterventions
UCPVax vaccineExperimentalUCPVax is a therapeutic vaccine derived from telomerase combined with Montanide ISA51 VG as adjuvant.
  • UCPVax

Eligibility Criteria

        Inclusion Criteria:

          -  Male or female patients, age ≥ 18 and ≤ 75 years old

          -  Written informed consent

          -  Histologically confirmed glioblastoma

          -  Patient with unmethylated MGMT (Methyl guanine methyl transferase) 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 Criteria:

          -  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:

               1. Chronic treatment with immunosuppressive drugs

               2. Ongoing requirement for supraphysiologic steroid defined as >10 mg prednisone
                  daily (or equivalent)

               3. 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.
      
Maximum Eligible Age:75 Years
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Immunogenicity
Time Frame:at day 60
Safety Issue:
Description:Anti-TERT specific T cell responses measured in peripheral blood using IFN-gamma ELISPOT

Details

Phase:Phase 1/Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Centre Hospitalier Universitaire de Besancon

Last Updated

May 14, 2020