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Trial record 15 of 27 for:    dipg | Recruiting, Not yet recruiting, Available Studies

Oncolytic Adenovirus, DNX-2401, for Naive Diffuse Intrinsic Pontine Gliomas

This study is currently recruiting participants.
See Contacts and Locations
Verified June 2017 by Sonia Tejada, Clinica Universidad de Navarra, Universidad de Navarra
Sponsor:
Collaborators:
DNAtrix, Inc.
Alcyone Lifesciences, Inc.
Information provided by (Responsible Party):
Sonia Tejada, Clinica Universidad de Navarra, Universidad de Navarra
ClinicalTrials.gov Identifier:
NCT03178032
First received: June 3, 2017
Last updated: NA
Last verified: June 2017
History: No changes posted
  Purpose
Oncolytic adenovirus for pediatric naive DIPG, to be infused after tumor biopsy through the same trajectory in the cerebellar peduncle.

Condition Intervention Phase
Brainstem Glioma Neoadjuvant Therapy Biological: DNX-2401 Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: Phase I Trial of DNX-2401 for Diffuse Intrinsic Pontine Glioma Newly Diagnosed in Pediatric Patients.

Resource links provided by NLM:


Further study details as provided by Sonia Tejada, Clinica Universidad de Navarra, Universidad de Navarra:

Primary Outcome Measures:
  • Safety, tolerability and toxicity of DNX-2401 injected in the cerebellar peduncle [ Time Frame: 12 weeks after virus injection ]
    The trial will look for hematologic and neurologic toxicity (NCI-CTCAE v 4.03).


Secondary Outcome Measures:
  • OS12 [ Time Frame: 12 months after virus injection ]
    Overall Survival at 12 months

  • Images response [ Time Frame: 12 months after virus injection ]
    Complete/partial response in MRI

  • QoL [ Time Frame: 12 months after virus injection ]
    measure quality of life baseline assessment and any changes over time

  • Samples collection [ Time Frame: 12 weeks after virus injection ]
    Collect tumor and blood samples for futures molecular and immune studies.


Estimated Enrollment: 12
Actual Study Start Date: May 30, 2017
Estimated Study Completion Date: December 30, 2019
Estimated Primary Completion Date: August 30, 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: single arm treatment DNX-2401
Single arm receiving virus DNX-2401 infusion after tumor biopsy
Biological: DNX-2401
Brain infusion of the virus through the cerebellar peduncle
Other Name: Delta-24

Detailed Description:
Diffuse pontine gliomas (DIPG) are one of the most lethal pediatric tumors. All treatment approaches for these tumors have failed, leaving a terrible prospect with median survival under one year, and survival at 5 years virtually of zero. Moreover, most of the long term survivors suffer from long-term side effects of the aggressive treatment. Thus, new therapeutic strategies are required that allow not only for more effective treatments of these tumors but also that defer the severe side effects derived from the current therapeutic choices. DNX-2401 is an oncolytic virus engineered to replicate specifically in tumor cells with an abnormal retinoblastoma (RB) pathway. Moreover, this virus infects cells through integrins, which are more abundant in glioma cells. Here we propose a phase I, unicentric, non-randomized clinical trial to study the safety and potential efficacy of intratumoral administration of DNX-2401 in DIPG. The virus administration will be done after stereotactic tumor biopsy, using the same trajectory, after verification of catheter position with intraoperative MRI. After 3-4 weeks patients will receive standard radiotherapy and/or chemotherapy. The primary objective is to confirm the safety of the target dose known from adults trials. Secondary endpoints are overall survival at 12 months (OS12), percentage of responses and induced immune response against tumor. The follow up includes close monitoring of neurological status, blood tests and brain MRI. If this trial shows evidence of safety and efficacy will propel a multicenter clinical trial.
  Eligibility

Ages Eligible for Study:   1 Year to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Informed consent OF PATIENT OR PARENTS
  2. Patient must be, in the investigator opinion, able to comply with all the protocol procedures.
  3. Age 1 - 18 years
  4. Negative pregnant blood test in case of fertile women (A woman is considered of childbearing potential (WOCBP), i.e. fertile, following menarche and unless permanently sterile. Permanent sterilization methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy.
  5. Patient newly diagnosed of DIPG in MRI
  6. Lansky Performance Status ≥ 70 before inclusion
  7. Lesion considered by the investigator to be accessible for stereotactic biopsy. Lesion location will allow injection without entrance of virus in the ventricular system.
  8. No previous treatment for DIPG

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 (Cº)].
  2. Investigational medication in the previous 30 days.
  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 if older than 16 years or parents ability when younger than 16, 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. Tumor with multiple locations or doubt in MRI of a DIPG.
  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 (aspartate transaminase) and/or ALT (alanine transaminase)> 3 times over upper normal laboratory level
  9. Neutrophils < 1 x 109/L
  10. Thrombocytes ≤ 100 x 109/L
  11. Hemoglobin < 9g/dl

13. Patients with Li-Fraumeni Syndrome or with a known germ line deficit in the retinoblastoma gene or its related pathways.

14. Vaccinations of any kind within 30 days prior to DNX-2401 administration. 15. Transfusions or medications (G-CSF) to treat pancytopenia or other hematological conditions within 28 days of baseline.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03178032

Contacts
Contact: Sonia Tejada, MD, PhD 0034948255400 ext 4590 stejada@unav.es
Contact: Jose M Galindo 0034948255400 ext 2527 jgalindom@unav.es

Locations
Spain
Clinica Universidad de Navarra Recruiting
Pamplona, Navarra, Spain, 31190
Contact: Sonia Tejada, MD, PhD    948255400 ext 4590    stejada@unav.es   
Contact: Jose Maria Galindo    948255400 ext 2527    jgalindom@unav.es   
Sub-Investigator: Ricardo Diez Valle, MD, PhD         
Sub-Investigator: Marta Alonso, PhD         
Sub-Investigator: Ana Patiño, PhD         
Sub-Investigator: Maite Garriz, MD         
Sub-Investigator: Miriam Giraldez, PhD         
Principal Investigator: Sonia Tejada, MD, PhD         
Sponsors and Collaborators
Clinica Universidad de Navarra, Universidad de Navarra
DNAtrix, Inc.
Alcyone Lifesciences, Inc.
Investigators
Principal Investigator: Sonia Tejada, MD, PhD Clinica Universidad de Navarra
  More Information

Publications:
Responsible Party: Sonia Tejada, MD, Clinica Universidad de Navarra, Universidad de Navarra
ClinicalTrials.gov Identifier: NCT03178032     History of Changes
Other Study ID Numbers: D24-DIPG
Study First Received: June 3, 2017
Last Updated: June 3, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: During the trail the results will be presented in scientific meetings. After the trial, a paper will be published by the IP

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Sonia Tejada, Clinica Universidad de Navarra, Universidad de Navarra:
Diffuse intrinsic pontine gliomas
Oncolytic adenovirus

Additional relevant MeSH terms:
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue

ClinicalTrials.gov processed this record on July 27, 2017