DNX-2440 Oncolytic Adenovirus for Recurrent Glioblastoma

  • STATUS
    Recruiting
  • End date
    Oct 16, 2022
  • participants needed
    24
  • sponsor
    Clinica Universidad de Navarra, Universidad de Navarra
Updated on 24 January 2021
measurable disease
karnofsky performance status
dexamethasone
gliosarcoma
recurrent glioblastoma
recurrent tumor
stereotactic biopsy

Summary

Patients with first or second recurrence of GBM will be treated with stereotactic injection of the oncolytic virus DNX-2440.

Description

After inclusion in the trial, stereotactic biopsy will be performed. In the same surgery, the experimental agent will be injected also by stereotactic system, in a different part of the lesion, in a region considered viable tumor, using a cannula especially designed for virus injection.

Follow-up will include clinical visits and MRI No other treatment for the tumor will be used until progression is documented. iRANO criteria and volumetric measurement of the tumor will be used.

Any further treatment after progression will be at the criteria of the treating physician

Details
Condition Glioblastoma Multiforme, Glioblastoma, Adult, Glioblastoma, Adult, Glioblastoma, Adult, Glioblastoma, Adult, Glioblastoma, Adult, Glioblastoma, Adult, Glioblastoma, Adult, glioblastoma, Glioblastoma, Adult
Treatment DNX 2440 injection, DNX-2440 injection
Clinical Study IdentifierNCT03714334
SponsorClinica Universidad de Navarra, Universidad de Navarra
Last Modified on24 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have any of these conditions: Glioblastoma, Adult or Glioblastoma Multiforme?
Do you have any of these conditions: Glioblastoma, Adult or Glioblastoma Multiforme or glioblastoma?
Patients willing and able to give informed consent
Patient must be, in the investigator opinion, able to comply with all the protocol procedures
Age 18
Negative pregnant test in case of fertile women
Patients with diagnosis of first or second recurrence of Glioblastoma or any of its variants (Gliosarcoma, Giant cell Glioblastoma or epithelioid Glioblastoma) based on histopathology at first diagnosis and clinical and radiological follow-up. Recurrences within the radiation field will be considered if there is confirmed growing of the lesion in two MRI, or occur at least 12 weeks after completion of radiotherapy, or if there is clear histopathological confirmation of tumor recurrence. This limitation does not apply for recurrences occurring outside the radiation field
A single measurable lesion bigger than 10 mm in two perpendicular diameters, considered appropriate for safe stereotactic biopsy and virus injection without entering the ventricle
No other chemotherapy or immunotherapy for the tumor in the four weeks previous to the inclusion
Karnofsky Performance Status 70 before inclusion
Must have adequate renal, bone marrow and liver function
Steroid-free or requiring stable doses of a maximum of 2mg dexamethasone /day or equivalent in the previous two weeks
A woman is considered fertile, following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. A high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a post-menopausal state in women not using hormonal contraception or hormonal replacement therapy. However, in the absence of 12 months of amenorrhea, a single FSH measurement is insufficient

Exclusion Criteria

Severe infections or intercurrent medical conditions including, but not limited to, severe renal, hepatic, heart or bone marrow failure, that, on investigators criteria, do not allow the inclusion. Patients must be afebrile at baseline [i.e., < 38 degrees (C)]
Patients with an enhancing lesion bigger than 25cc, including necrotic tumor portions encircled inside the enhancing areas
Subjects with immunodeficiency, autoimmune conditions or active hepatitis
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
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
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
Severe bone marrow hypoplasia
AST and/or ALT > 4 times over upper normal laboratory level
Neutrophils < 1.5 x 109/L
Thrombocytes 100 x 109/L
Hemoglobin < 9g/dl
Multiple lesions, extensive ill-defined diffuse lesions, or lesions considered risky for stereotactic injection of virus, like periventricular lesions
Patients with Li-Fraumeni Syndrome or with a known germ line deficit in the retinoblastoma gene or its related pathways
Biologic/immunotherapy (e.g., IL-2, IL-12, interferon) within 4 weeks of DNX-2440 administration
Vaccination of any kind within 4 weeks prior to DNX-2440 administration
Inability to undergo MRI examination for any reason
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