Oncolytic HSV-1716 in Treating Younger Patients With Refractory or Recurrent High Grade Glioma That Can Be Removed By Surgery

Stopped early · Phase 1

Conditions studied: Recurrent Childhood Anaplastic Astrocytoma, Recurrent Childhood Anaplastic Oligoastrocytoma, Recurrent Childhood Anaplastic Oligodendroglioma, Recurrent Childhood Giant Cell Glioblastoma, Recurrent Childhood Glioblastoma, Recurrent Childhood Gliomatosis Cerebri, Recurrent Childhood Gliosarcoma

In brief

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.

Key facts

Study ID

NCT02031965

Run by

Pediatric Brain Tumor Consortium

People needed

2

Starts

2013-12-01

Expected to finish

2016-05-01

Last updated by the study team

2016-05-30

Who can join

Age: 12 and older, up to 21. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Imaging evaluations necessary to establish eligibility for study entry must be done within three (3) weeks prior to registration; all other evaluations necessary to establish eligibility for study entry must be done within two (2) weeks prior to registration; in the event that the patient's condition deteriorates (performance score < 60) within 48 hours prior to the injection the patient is no longer eligible to receive HSV1716 injection
• Patients must have a histologically-confirmed primary diagnosis of high-grade glioma (HGG) (such as glioblastoma multiforme, gliosarcoma, anaplastic oligodendroglioma, anaplastic ganglioglioma, high grade astrocytoma, not otherwise specified [NOS]) that is recurrent or refractory to conventional therapy; patients with metastatic disease are not eligible
• Patients must be those for whom surgical resection is clinically indicated; the intent of surgical resection may include debulking or attempt to resect as much of the tumor as safely feasible; if a gross total or near total resection is not feasible, HSV1716 injection into the wall of the resection cavity, encompassing residual tumor, is permissible
• Patients must be amenable to receiving 1 dose of HSV1716 intra-operatively with planned HSV1716 injection sites >= 1 cm from the ventricular system AND meet at least one of the criteria below based upon pre-surgical magnetic resonance imaging (MRI):
• Tumor is >= 1 cm from the ventricular system
• Patients whose tumors that are =< 1 cm from the ventricular system are eligible if there is sufficient space within the tumor cavity and/or residual tumor to perform the HSV 1716 injections that are >= 1 cm from the ventricular system
• An intraoperative MRI upon resection will confirm the distance of the planned injection sites from the ventricular system prior to the HSV1716 injection; intra-operatively, the neurosurgeon may decide to not inject the HSV1716 or may revise the sites of HSV1716 injection if injection cannot be guaranteed >= 1 cm from the ventricular system; patient will removed from the study if there are not sufficient areas in the tumor cavity to guarantee injection of HSV1716 >= 1 cm from the ventricular system
• Patients must have received prior therapy other than surgery and must have fully recovered from the acute treatment related toxicities of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study
• Patients must have received their last dose of known myelosuppressive anticancer chemotherapy at least three (3) weeks prior to study registration treatment or at least six (6) weeks if nitrosourea
• Investigational/Biologic agent:
• Biologic or investigational agent (anti-neoplastic): Patient must have recovered from any acute toxicity potentially related to the agent and received their last dose of the investigational or biologic agent >= 7 days prior to study registration
• For agents that have known adverse events occurring beyond 7 days after administration, this period must be extended beyond the time during which adverse events are known to occur
• Monoclonal antibody treatment: At least three half-lives must have elapsed prior to registration; Note: A list of the half-lives of commonly used monoclonal antibodies is available on the Pediatric Brain Tumor Consortium (PBTC) webpage under Generic Forms and Templates
• Patients must have had their last fraction of:
• Craniospinal irradiation (> 24 Gray [Gy]) or total body irradiation > 3 months prior to registration
• Focal irradiation to symptomatic metastatic sites > 4 weeks prior to registration
• Local palliative external beam radiation therapy (XRT) (small port) >= 4 weeks
• If prior total-body irradiation (TBI), craniospinal XRT or if >= 50% radiation of pelvis >= 6 months must have elapsed
• If other substantial bone marrow (BM) radiation >= 6 weeks must have elapsed
• Patient must be:
• >= 6 months since allogeneic bone marrow transplant prior to registration
• Stem cell transplant or rescue without TBI: No evidence of active graft vs. host disease and >= 3 months must have elapsed since transplant
• Karnofsky performance scale (KPS for > 16 years of age) or Lansky performance score (LPS for =< 16 years of age) assessed within two weeks of registration must be >= 60
• Hemoglobin: >= 10 g/dl
• Absolute neutrophil count: >= 1000/mm\^3

You may not qualify if…

• Patients with metastatic disease i.e. leptomeninges, multi-focal lesions in the CNS
• Patients whose tumor lies within 1 cm of the ventricular system
• Patients who are receiving any other investigational agents
• Patients who are currently receiving other anti-cancer agents are excluded from this trial
• Patients with history of prior HSV encephalitis or encephalitis due to other etiologies
• There is no available information regarding human fetal or teratogenic toxicities
• Pregnant women are excluded to avoid the risk of systemic intrauterine/neonatal HSV infection
• Males or females of reproductive potential may not participate unless they have agreed to use an effective contraceptive method from the time of study entry to a period of no less than four months post the HSV1716 injection
• Women who participate in this study must agree not to breastfeed from study entry to a period of no less than four months post the HSV1716 injection
• Subjects whose primary physicians determine that anti-HSV antiviral therapy (such as acyclovir, ganciclovir, foscarnet, etc.) cannot be safely discontinued from 2 days prior to the injection to 28 days following the injection are excluded from this study
• Patients on systemic anticoagulants are excluded from this study
• Patients with any clinically significant unrelated systemic illness (serious infections or significant cardiac, pulmonary, hepatic or other organ dysfunction), that would compromise the patient's ability to tolerate protocol therapy or would likely interfere with the study procedures or results

Where it is running

• Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States

Full record on ClinicalTrials.gov

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