Clinical Trial Details
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NCT03152318 : A Study of the Treatment of Recurrent Malignant Glioma With rQNestin34.5v.2
PhasePhase 1
AgesMin: 18 Years Max: N/A
Inclusion Criteria:

- At the time of surgery, frozen biopsy confirmation of high grade or malignant glioma
by neuropathologist. To be confirmed at time of surgery, after registration in OnCore.

- Participants must have prior diagnosis of glioma (astrocytoma, malignant astrocytoma,
oligodendroglioma, anaplastic oligodendroglioma, mixed oligo-astrocytoma), exclusive
of ependymoma, ganglioglioma, pylocytic/pylomyxoid astrocytoma as confirmed by a
neuropathologist or by a previous local pathology report.

- Prior history of external beam radiotherapy = 5,000 cGy delivered to the tumor at
least 4 weeks prior to registration;

- Prior history of temozolomide chemotherapy provided concurrent to external beam
radiotherapy and after as per current standard of care. However, temozolomide would
not be required to have been provided concomitantly or after radiation if the patient
had unmethylated MGMT promoter or if the patient initially was diagnosed with a low
grade glioma. At least 8 weeks must have passed from the last dose of temozolomide and
first dose of cyclophosphamide and/or rQNestin34.5v.2;

- If participant was treated with bevacizumab, at least 4 weeks must elapse before
treatment with either agent (Cyclophosphamide or rQNestin34.5v.2);

- Recurrent lesion must be = 1.0 cm in diameter as determined by MRI;

- Normal hematological, renal and liver function as defined below: Leukocytes
=3,000/mcL; Absolute lymphocyte count > 500/ mcL; Absolute neutrophil count
=1,500/mcL; platelets =100,000/mcL; PT or PTT <1.5 x institutional upper limit;
Hemoglobin >10.0 g/dL; Total serum bilirubin within normal institutional limits;
AST(SGOT)/ALT(SGPT) =2.5 × institutional upper limit of normal; Serum creatinine
within normal institutional limits OR Creatinine clearance =60 mL/min/1.73 m2 for
participants with creatinine levels above institutional normal;

- Karnofsky Performance Score =70.

- Age = 18 years;

- Ability to understand and the willingness to sign a written informed consent document;

- The effects of rQNestin34.5v.2 and cyclophosphamide on the developing human fetus are
unknown. For this reason and because cytotoxic & immunomodulating agents as well as
other therapeutic agents used in this trial are known to be teratogenic, women of
child-bearing potential and men must agree to use adequate contraception (hormonal or
barrier method of birth control; abstinence) prior to study entry and for the duration
of study participation including 3 months following the study. Should a woman become
pregnant or suspect she is pregnant while she or her partner is participating in this
study, she should inform her treating physician immediately. Men treated or enrolled
on this protocol must also agree to use adequate contraception prior to the study and
for the duration of study participation including 3 months following the study. Women
of child-bearing potential must have a negative serum pregnancy test within 48 hours
of study registration.

- Steroid regimen stable or decreasing for at least 7 days prior to inoculation;

- Ability to undergo MRI scanning with contrast;

- Subjects with any recurrence (first, second, third, etc recurrence) will be able to be

Exclusion Criteria:

Participants who exhibit any of the following conditions prior to initiating study
treatment will not be eligible for this study:

- Participants with significant renal or liver disease

- Participants with progressive systemic malignancy.

- Known chronic infections with HIV, hepatitis B or C; participants with a history of
resolved Hepatitis A may be included in the trial.

- Participants with active viral, bacterial or fungal infection requiring concurrent
antiviral or antibiotics.

- Subjects with active HSV1 infection on current valacyclovir, acyclovir or ganciclovir
therapy must be off treatment with any of these agents at least 7 days prior to

- History of allergic reactions attributed to compounds of similar chemical or biologic
composition to cyclophosphamide (only for arm B).

- Active, known, or suspected immunosuppressive disorders, such as acquired or
congenital immune deficiency syndromes and autoimmune diseases

- Unacceptable anesthesia risk

- Serious cardiopulmonary medical condition

- Pregnant or lactating females

- Recurrent glioma where injection in either arm A or B of the biologic agent would
require access and/or considerable spillage into the ventricular system.

- Prior participant in another protocol using an investigational agent or device within
5 half-lives of the investigational agent.

- Known HIV seropositivity.

- Concurrent therapy with drugs active against HSV (acyclovir, valaciclovir,
penciclovir, famciclovir, ganciclovir, foscarnet, cidofovir). Participants must be off
treatment with these agents for at least 7 days prior to surgery.

- Active oral or genital herpes lesions.

- Participants who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for
nitrosoureas or mitomycin C) prior to entering the study or those who have not
recovered from adverse events due to agents administered more than 4 weeks earlier.

- Participants who are receiving any other investigational agents.

- Uncontrolled intercurrent illness including, but not limited to, ongoing or active
infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
arrhythmia, or psychiatric illness/social situations that would limit compliance with
study requirements.

- Participants with tumor = 1 cm proximity to the ventricles will be allowed to enroll.
However the study agent (rQNestin34.5v.2) may not be injected in any area that is
within 1 cm of the ventricle regardless of where the tumor is located.
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