A Phase I Study of Ad-RTS-hIL-12, an Inducible Adenoviral Vector Engineered to Express hIL-12 in the Presence of the Activator Ligand Veledimex in Subjects With Recurrent or Progressive Glioblastoma or Grade III Malignant Glioma

Who is this study for? Patients with recurrent or progressive glioblastoma or grade III malignant glioma
What treatments are being studied? Ad-RTS-hIL-12+Veledimex
Status: Completed
Location: See all (6) locations...
Intervention Type: Biological, Drug
Study Type: Interventional
Study Phase: Phase 1

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.

Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: No

• 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

• Targeted agents including small-molecule tyrosine kinase inhibitors: 2 weeks

• Experimental immunotherapies: 3 months

• Vaccine based therapy: 3 months

• Able to undergo standard MRI scans with contrast agent

• Karnofsky Performance Status ≥ 70

• Adequate bone marrow reserves and liver and kidney function, as assessed by the following laboratory requirements:

• Hemoglobin ≥ 9 g/L

• Lymphocytes > 500/ mm3

• Absolute Neutrophil Count ≥ 1500/ mm3

• Platelets ≥ 100,000/ mm3

• Serum creatinine ≤ 1.5 x ULN

• AST (SGOT) and ALT (SGPT) ≤ 2.5 x ULN. For subjects with documented liver metastases, ALT and AST ≤ 5 × ULN

• Total bilirubin < 1.5 x ULN

• International Normalized Ratio (INR) and activated Partial Thromboplastin Time [PTT] within normal institutional limits

• Male and female subjects must agree to use a highly reliable method of birth control (expected failure rate less than 5% per year) from the screening visit through 28 days after the last dose of study drug. Women of childbearing potential must have a negative pregnancy test at screening.

United States
Los Angeles
University of California - San Francisco
San Francisco
University of Chicago
Brigham & Women's
MD Anderson Cancer Center
Time Frame
Start Date: June 2015
Completion Date: August 2019
Target number of participants: 40
Experimental: Ad-RTS-hIL-12+veledimex
varying doses of intratumoral Ad-RTS-hIL-12 (INXN-2001) and oral veledimex (activator ligand).
Leads: Alaunos Therapeutics

This content was sourced from clinicaltrials.gov

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