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DNX-2401 With Interferon Gamma (IFN-γ) for Recurrent Glioblastoma or Gliosarcoma Brain Tumors

Study Purpose

Glioblastoma (GBM) and gliosarcoma (GS) are the most common and aggressive forms of malignant primary brain tumor in adults and can be resistant to conventional therapies. The purpose of this Phase Ib study is to evaluate how well a recurrent glioblastoma or gliosarcoma tumor responds to one injection of DNX-2401, a genetically modified, conditionally replicative and oncolytic human-derived adenovirus. DNX-2401 is delivered directly into the tumor where it may establish an active infection by replicating in and killing tumor cells.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Glioblastoma or gliosarcoma in first or second recurrence only.
  • - Documented tumor recurrence or progression after failing prior surgical resection, chemotherapy, or radiation.
  • - Tumor size greater than or equal to 1.0 cm in two perpendicular diameters.
  • - Not undergoing surgical resection or for whom gross total resection is not possible.
  • - Karnofsky Performance Status greater than or equal to 70%

    Exclusion Criteria:

    - Multiple intracranial malignant glioma lesions.
  • - Tumor location or involvement that would result in risk of ventricular penetration during tumor injection.
  • - Tumor involving both hemispheres or that which involves the subependyma or suspected cerebrospinal fluid dissemination.
  • - Tumor involving brain stem.
  • - Documented extracranial metastasis.
  • - Inability to undergo MRI.
  • - Pregnant or nursing females.
  • - Any medical condition that precludes the surgery necessary to administer DNX-2401 into the tumor using the cannula.
  • - Immunocompromised subjects or those with autoimmune conditions, active hepatitis or positive for human immunodeficiency virus (HIV) - Li-Fraumeni Syndrome.
Other protocol-defined inclusion/exclusion criteria may apply as outlined in the relevant protocol version

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT02197169
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 DNAtrix, Inc.
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Nam Tran, MD, PhDKaren Fink, MD, PhDVinay Puduvalli, MBBSFrederick Lang, MD
Principal Investigator Affiliation Moffitt Cancer CenterBaylor University: Charles A. Sammons Cancer CenterOhio State University: James Cancer CenterM.D. Anderson Cancer Center
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Industry
Overall Status Completed
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Glioblastoma or Gliosarcoma
Additional Details

Enrollment has been completed for the randomized portion of the study with ongoing evaluation of tumor response and safety. No additional subjects will be randomized or receive interferon gamma (IFN-γ). The non-randomized portion of the study is open for screening and enrollment. Eligible subjects will receive a single intratumoral injection of DNX-2401 into a recurrent glioblastoma or gliosarcoma brain tumor using the Alcyone MEMS Cannula (AMC™) System (cannula). Tumor response and safety will be evaluated. After receiving DNX-2401, subjects will return to the clinic for study visits at regular intervals for safety monitoring, MRI scans and other assessments for up to 18 months. Thereafter, they will be followed closely for safety and survival.

Arms & Interventions

Arms

Experimental: DNX-2401 alone

Single intratumoral injection of DNX-2401

Experimental: DNX-2401 + Interferon gamma (IFN-γ)

Interferon gamma (IFN-γ) beginning at Day 14

Interventions

Drug: - Single intratumoral injection of DNX-2401

In the randomized group, following brain tumor biopsy and histological confirmation of recurrent glioblastoma/gliosarcoma, a single injection of DNX-2401 was administered directly into the brain tumor with or without subsequent interferon gamma (IFN-γ) No additional subjects will be randomized. A single intratumoral dose of DNX-2401 will be delivered by cannula.

Drug: - Interferon-gamma

In the randomized group, a single injection of DNX-2401 was followed by interferon gamma (IFN-γ). No additional subjects will be randomized or receive IFN-γ following DNX-2401

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Moffitt Cancer Center, Tampa, Florida

Status

Address

Moffitt Cancer Center

Tampa, Florida, 33612

The Ohio State University, Columbus, Ohio

Status

Address

The Ohio State University

Columbus, Ohio, 43210

Dallas, Texas

Status

Address

Baylor University: Charles A. Sammons Cancer Center

Dallas, Texas, 75246

UT MD Anderson Cancer Center, Houston, Texas

Status

Address

UT MD Anderson Cancer Center

Houston, Texas, 77030

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