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DNX-2440 Oncolytic Adenovirus for Recurrent Glioblastoma

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ClinicalTrials.gov Identifier: NCT03714334
Recruitment Status : Recruiting
First Posted : October 22, 2018
Last Update Posted : June 25, 2020
Sponsor:
Collaborator:
DNAtrix, Inc.
Information provided by (Responsible Party):
Clinica Universidad de Navarra, Universidad de Navarra

Tracking Information
First Submitted Date  ICMJE October 16, 2018
First Posted Date  ICMJE October 22, 2018
Last Update Posted Date June 25, 2020
Actual Study Start Date  ICMJE October 16, 2018
Estimated Primary Completion Date April 16, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 19, 2018)
Incidence of Treatment-Emergent Adverse Events after brain administration of DNX-2440. [ Time Frame: 8 weeks ]
Incidence and severity of adverse effects will be collected and described
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 19, 2018)
  • Overall Survival at 12 months (OS12) [ Time Frame: 12 months ]
    rate of patients surviving at 12 months since injection
  • Overall survival [ Time Frame: 25 months ]
    Survival along the whole interval of follow-up
  • Overall response rate (ORR) [ Time Frame: 6 months ]
    total of patients with Complete responses plus partial responses
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE DNX-2440 Oncolytic Adenovirus for Recurrent Glioblastoma
Official Title  ICMJE Phase I Trial of DNX-2440 Oncolytic Adenovirus in Patients With Recurrent Glioblastoma
Brief Summary Patients with first or second recurrence of GBM will be treated with stereotactic injection of the oncolytic virus DNX-2440.
Detailed 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

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Glioblastoma
  • Glioblastoma, Adult
Intervention  ICMJE Drug: DNX-2440 injection
DNX-2440 virus will be injected stereotactically
Study Arms  ICMJE Experimental: DNX-2440 injection
all the patients included will be treated with the experimental agent
Intervention: Drug: DNX-2440 injection
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 19, 2018)
24
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 16, 2022
Estimated Primary Completion Date April 16, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 ≥18
  4. Negative pregnant test in case of fertile women*
  5. 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
  6. 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.
  7. No other chemotherapy or immunotherapy for the tumor in the four weeks previous to the inclusion
  8. Karnofsky Performance Status ≥ 70 before inclusion.
  9. Must have adequate renal, bone marrow and liver function.
  10. 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:

  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. Patients with an enhancing lesion bigger than 25cc, including necrotic tumor portions encircled inside the enhancing areas.
  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. Multiple lesions, extensive ill-defined diffuse lesions, or lesions considered risky for stereotactic injection of virus, like periventricular lesions.
  13. Patients with Li-Fraumeni 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-2440 administration.
  15. Vaccination of any kind within 4 weeks prior to DNX-2440 administration.
  16. Inability to undergo MRI examination for any reason.

    -

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Jaime Gallego, Principal Investigator +34948255400 jgallego@unav.es
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03714334
Other Study ID Numbers  ICMJE D2440GBM1
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Clinica Universidad de Navarra, Universidad de Navarra
Study Sponsor  ICMJE Clinica Universidad de Navarra, Universidad de Navarra
Collaborators  ICMJE DNAtrix, Inc.
Investigators  ICMJE Not Provided
PRS Account Clinica Universidad de Navarra, Universidad de Navarra
Verification Date December 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP