Spots Global Cancer Trial Database for Oncolytic HSV-1716 in Treating Younger Patients With Refractory or Recurrent High Grade Glioma That Can Be Removed By Surgery

Study Description

Brief Summary: This phase I trial studies the side effects and the safety of injecting HSV1716 (a new experimental therapy) into or near the tumor resection cavity. The injection will be done at the time of surgery. HSV1716 is a virus that has a gene which has been changed or removed (mutated) in such a way that lets the virus multiply in dividing cells of the tumor and kills the tumor cells.

Detailed Description: PRIMARY OBJECTIVES: I. To determine whether intratumoral/peritumoral injection of HSV1716 (oncolytic HSV-1716) is safe in children with recurrent high-grade gliomas amenable to resection. II. To estimate the maximum tolerated dose (MTD) or a recommended Phase II dose of intratumoral/peritumoral injection of HSV1716. III. To describe any dose-limiting toxicities (DLT) of intratumoral/peritumoral injection of HSV1716 at the doses given to children with high-grade gliomas. IV. To evaluate changes in tumor enhancement, quantitative magnetic resonance (MR) measures of tumor perfusion (relative cerebral blood volume \[rCBV\], transfer coefficient \[k\^trans\], fractional blood-plasma volume \[Vp\] and extravascular extracellular space per unit volume tissue \[Ve\] values and apparent diffusion coefficient \[ADC\]) in response to HSV1716 injection. SECONDARY OBJECTIVES: I. To measure antiviral immune response in patients with refractory high-grade gliomas injected with HSV1716. II. To measure the systemic viremia and viral shedding following intratumoral/peritumoral administration of HSV1716. III. To preliminarily describe the antitumor activity of HSV1716 injection within the confines of a Phase I study. IV. To evaluate anti-tumor immune cellular and humoral immune responses. V. To evaluate changes in fluorodeoxyglucose (FDG)- positron emission tomography (PET) uptake in response to HSV1716 injection. VI. To evaluate changes in tumor choline values using magnetic resonance (MR) spectroscopy in response to HSV1716 injection and further delineate from progressive disease versus pseudo-progression post therapy. OUTLINE: This is a dose-escalation study. Patients receive oncolytic HSV-1716 intratumorally (IT) and peritumorally after undergoing surgical tumor resection. Patients also receive dexamethasone intravenously (IV) prior to and 6 and 12 hours after surgery. After completion of study treatment, patients are followed up every 2 months for 1 year, every 6 months for 4 years, and then annually for 10 years.

Keywords

Eligibility

Minimum Age: 12 Years

Eligible Ages: CHILD, ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Contact Details

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