Recurrent Childhood Glioblastoma Clinical Trial
Official title:
A Phase I Study of Intratumoral/Peritumoral Herpes Simplex Virus-1 Mutant HSV1716 in Patients With Refractory or Recurrent High Grade Gliomas (HGG)
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.
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.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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