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Anticancer Therapeutic Vaccination Using Telomerase-derived Universal Cancer Peptides in Glioblastoma (UCPVax-Glio)

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ClinicalTrials.gov Identifier: NCT04280848
Recruitment Status : Recruiting
First Posted : February 21, 2020
Last Update Posted : July 31, 2020
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Besancon

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 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).


Condition or disease Intervention/treatment Phase
Glioblastoma Drug: UCPVax Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 28 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Anticancer Therapeutic Vaccination Using Telomerase-derived Universal Cancer Peptides in Glioblastoma
Actual Study Start Date : May 26, 2020
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : July 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: UCPVax vaccine
UCPVax is a therapeutic vaccine derived from telomerase combined with Montanide ISA51 VG as adjuvant.
Drug: UCPVax

The UCPVax vaccination protocol will start at least one month after glioblastoma patients have completed the concomitant radiochemotherapy (Radiotherapy + Temozolomide RT/TMZ), without the 6 additional monthly cures of temozolomide, with a maximum of 45 days.

UCPVax vaccine will be emulsified in Montanide ISA 51 and injected subcutaneously at days 1, 8, 15, 29, 36 and 43 (priming phase) following by boost vaccination one month after the last injection and then every 8 weeks for 12 months maximum.





Primary Outcome Measures :
  1. Immunogenicity [ Time Frame: at day 60 ]
    Anti-TERT specific T cell responses measured in peripheral blood using IFN-gamma ELISPOT



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04280848


Contacts
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Contact: Olivier ADOTEVI, Pr +33381668166 olivier.adotevi@univ-fcomte.fr

Locations
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France
CHU Besançon Recruiting
Besançon, France
Contact: Clotilde VERLUT, Dr         
Principal Investigator: Clotilde VERLUT, Dr         
CHU Bordeaux Not yet recruiting
Bordeaux, France
Contact: Charlotte BRONNIMANN, Dr         
Centre Georges François Leclerc Recruiting
Dijon, France
Contact: François GHIRINGHELLI, Pr         
Principal Investigator: François GHIRINGHELLI, Pr         
Hôpital Saint-Louis Recruiting
Paris, France
Contact: Antoine CARPENTIER, Pr         
Principal Investigator: Antoine CARPENTIER, Pr         
Sponsors and Collaborators
Centre Hospitalier Universitaire de Besancon
Investigators
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Principal Investigator: Clotilde VERLUT, Dr CHU Besançon
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Responsible Party: Centre Hospitalier Universitaire de Besancon
ClinicalTrials.gov Identifier: NCT04280848    
Other Study ID Numbers: N/2013/67
First Posted: February 21, 2020    Key Record Dates
Last Update Posted: July 31, 2020
Last Verified: July 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Glioblastoma
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue