DNX-2401 With Interferon Gamma (IFN-γ) for Recurrent Glioblastoma or Gliosarcoma Brain Tumors (TARGET-I)
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| ClinicalTrials.gov Identifier: NCT02197169 |
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Recruitment Status :
Completed
First Posted : July 22, 2014
Last Update Posted : July 16, 2018
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Glioblastoma or Gliosarcoma | Drug: Single intratumoral injection of DNX-2401 Drug: Interferon-gamma | Phase 1 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 37 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | A Phase 1b, Randomized, Multi-center, Open-label Study of a Conditionally Replicative Adenovirus (DNX-2401) and Interferon Gamma (IFN-γ) for Recurrent Glioblastoma or Gliosarcoma (TARGET-I) |
| Actual Study Start Date : | September 11, 2014 |
| Actual Primary Completion Date : | March 15, 2018 |
| Actual Study Completion Date : | March 15, 2018 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: DNX-2401 alone
Single intratumoral injection of DNX-2401
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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. Other Names:
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Experimental: DNX-2401 + Interferon gamma (IFN-γ)
Interferon gamma (IFN-γ) beginning at Day 14
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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. Other Names:
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
Other Names:
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- Objective response rate (ORR) determined by MRI scan review [ Time Frame: 1.5 years ]Interval tumor size change will be measured
- Incidence and severity of adverse events, including changes in laboratory test results and neurological examination findings [ Time Frame: 1.5 years ]Events are classified using Common Terminology Criteria for Adverse Events (CTCAE) version 4.03
- Number of subjects with immunological and biological effects after DNX-2401 with Interferon gamma [ Time Frame: 1.5 years ]Laboratory test results and other assessments will be utilized to determine effects
- Changes in steroid use (dose and frequency) and clinical and KPS status overall and per study arm assignment [ Time Frame: 1.5 years ]
- Overall survival (OS), progression-free survival (PFS), and clinical benefit rate (CBR). [ Time Frame: 1.5 years ]
- Changes in responses to quality of life questionnaires [ Time Frame: 1.5 years ]
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, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02197169
| United States, Florida | |
| Moffitt Cancer Center | |
| Tampa, Florida, United States, 33612 | |
| United States, Ohio | |
| The Ohio State University | |
| Columbus, Ohio, United States, 43210 | |
| United States, Texas | |
| Baylor University: Charles A. Sammons Cancer Center | |
| Dallas, Texas, United States, 75246 | |
| UT MD Anderson Cancer Center | |
| Houston, Texas, United States, 77030 | |
| Principal Investigator: | Nam Tran, MD, PhD | Moffitt Cancer Center | |
| Principal Investigator: | Karen Fink, MD, PhD | Baylor University: Charles A. Sammons Cancer Center | |
| Principal Investigator: | Vinay Puduvalli, MBBS | Ohio State University: James Cancer Center | |
| Principal Investigator: | Frederick Lang, MD | M.D. Anderson Cancer Center |
| Responsible Party: | DNAtrix, Inc. |
| ClinicalTrials.gov Identifier: | NCT02197169 |
| Other Study ID Numbers: |
2401BT-IFN-001 |
| First Posted: | July 22, 2014 Key Record Dates |
| Last Update Posted: | July 16, 2018 |
| Last Verified: | July 2018 |
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Brain Brain Cancer Brain Neoplasms Central Nervous System Diseases Central Nervous System Neoplasms CNS Conditionally Replication-Competent Adenovirus DNX-2401 Delta-24-RGD Glioma Glioblastoma Gliosarcoma Interferon gamma |
Malignant brain tumor Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Nervous System Diseases Alcyone Lifesciences AMC™ Cannula Alcyone MEMS Cannula (AMC™) System |
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Glioblastoma Gliosarcoma Astrocytoma Glioma Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type |
Neoplasms Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Interferons Interferon-gamma Antineoplastic Agents Antiviral Agents Anti-Infective Agents |