A Study of Ad-RTS-hIL-12 With Veledimex in Subjects With Glioblastoma or Malignant Glioma (NCT02026271) | Clinical Trial Compass
CompletedPhase 1
A Study of Ad-RTS-hIL-12 With Veledimex in Subjects With Glioblastoma or Malignant Glioma
United States40 participantsStarted 2015-06
Plain-language summary
This research study involves an investigational product: Ad-RTS-hIL-12 given with veledimex for production of human IL-12. IL-12 is a protein that can improve the body's natural response to disease by enhancing the ability of the immune system to kill tumor cells and may interfere with blood flow to the tumor.
The main purpose of this study is to evaluate the safety and tolerability of a single tumor injection of Ad-RTS-hIL-12 given with oral veledimex.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. Male or female subjects ≥ 18 and ≤ 75 years of age
✓. Provision of written informed consent for tumor resection, stereotactic surgery, tumor biopsy, samples collection and treatment with investigational products prior to undergoing any study procedures
✓. Histologically confirmed supratentorial glioblastoma or other WHO grade III or IV malignant glioma from archival tissue.
✓. Evidence of tumor recurrence/progression by MRI (RANO criteria) post standard initial therapy.
✓. Previous standard of care anti-tumor treatment including surgery and/or biopsy and chemoradiation. The washout periods from prior therapies are intended as follows:
✓. Nitrosoureas: 6 weeks
✓. Other cytotoxic agents: 4 weeks
✓. Anti-angiogenic agents including bevacizumab: 4 weeks
Exclusion criteria
✕. Radiotherapy within 4 weeks or less prior to starting first veledimex dose
✕. Subjects with clinically significant increased intracranial pressure or uncontrolled seizures.
✕. Known immunosuppressive disease, autoimmune conditions, and /or chronic viral infections
✕. Use of systemic antibacterials, antifungals or antivirals for the treatment of acute clinically significant infection within 2 weeks of first veledimex dose. Concomitant therapy for chronic infections is not allowed. Subjects must be afebrile prior to Ad-RTS-hIL-12 injection; only prophylactic antibiotic use is permitted perioperatively.
What they're measuring
1
Safety and Tolerability of Varying Doses of Intratumoral Ad-RTS-hIL-12 and Oral Veledimex Doses in Subjects With Recurrent or Progressive Glioblastoma or Grade III Malignant Glioma
✕. Use of enzyme-inducing anti-epileptic drugs (EIAED) within 7 days prior to the first dose of study drug.
✕. Other concurrent clinically active malignant disease, requiring treatment, with the exception of non-melanoma cancers of the skin or carcinoma in-situ of the cervix or non-metastatic prostate cancer.