Phase II randomized trial of DNX-2401 oncolytic adenovirus added to standard of care for newly diagnosed glioblastoma

Phase 1

• Conditions: Multiforme Glioblastom (MGB) is the more common malignant brain tumor, with an incidence around 4 cases per 100.000 hab/year.; MedDRA version: 19.0Level: LLTClassification code 10029110Term: Neoplasms of unspecified natureSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2016-001600-40-ES
• Lead Sponsor: Clínica Universidad de Navarra

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-07-04
• Last Update Posted: 2 June 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 42

Inclusion Criteria

1. Patients willing and able to give informed consent.
2. Patient must be, in the investigator opinion, able to comply with all the protocol procedures.
3. Age over 18
4. Negative pregnant test in case of fertile women*
5. Patients with suspected diagnosis of Glioblastoma based on MRI,
5. The tumor should be considered candidate to resection surgery by the investigator criteria or being less than 4cm in bigger diameter if the tumor is considered unresectable or the patient is unwilling to have resection surgery.
6. A diagnosis of High Grade Glioma should be confirmed during surgical procedure.
7. Karnofsky Performance Status = 60 before inclusion Or could use candidate to resection surgery in number 5 to select cases with good enough situation and eliminate this criterium, preoperative situation in newly diagnosed can be tricky as sometimes a deficit at presentation of the disease can improve.
8. Must have adequate renal, bone marrow and liver function.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 30
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 12

Exclusion Criteria

1.Severe infections or intercurrent medical conditions including, but not limited to, severe renal, hepatic, heart or bone marrow failure, that, on investigator´s criteria, do not allow the inclusion. Patients must be afebrile at baseline [i.e., < 38 degrees (C )].
2.Previous treatment for the suspected glioblastoma with radiotherapy, chemotherapy, or immunotherapy. Previous partial resection is not an exclusion criterium.
3.Subjects with immunodeficiency, autoimmune conditions or active hepatitis.
4.Any medical or psychological condition that might interfere with the subject's ability to participate or give informed consent or would compromise the patient’s ability to tolerate therapy or any disease that will obscure toxicity or dangerously alter drug metabolism.
5.Current diagnosis of other cancer except in situ cervical cancer, basal or squamous cell carcinoma of the skin. Patients with a history of another cancer remain eligible if they are cancer free for at least three years.
6.Pregnant or breast-feeding females will be excluded, due to the risk for the fetal development of a recombinant virus containing genes related to cellular growth and differentiation.
7.Severe bone marrow hypoplasia.
8.AST and/or ALT > 4 times over upper normal laboratory level.
9.Neutrophils < 1.5 x 109/L
10.Thrombocytes = 100 x 109/L
11.Hemoglobin < 9g/dl
12.If final pathology diagnose of a patient would fail to confirm the suspected diagnosis of glioblastoma or any of its variants (like gliosarcoma, giant-cell glioblastoma, or any other), that patient would follow the procedures of the trial and would be counted for toxicity analysis, but not for survival analysis.
13.Patients with Li-Fraumini Syndrome or with a known germ line deficit in the retinoblastoma gene or its related pathways.
14.Biologic/immunotherapy (e.g., IL-2, IL-12, interferon) within 4 weeks of DNX-2401 administration.
15.Vaccination of any kind within 30 days prior to DNX-2401 administration.
16. Inability to undergo MRI examination for any reason.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified