Clinical Trial Details
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NCT02924038 : A Study of Varlilumab and IMA950 Vaccine Plus Poly-ICLC in Patients With WHO Grade II Low-Grade Glioma (LGG)
PhasePhase 1
AgesMin: 18 Years Max: N/A
Inclusion Criteria:

- Patients must be = 18 years old.

- Pathological criteria - Participants must have WHO grade II astrocytoma,
oligoastrocytoma or oligodendroglioma that has been histologically confirmed by prior
biopsy or surgical resection. If patients have already undergone biopsy and have
pathological diagnosis in a non-UCSF institute, pathology must be reviewed and
confirmed at UCSF.

- Patients must be positive for HLA-A2 based on flow-cytometry or genotyping

- Before enrollment, patients must show non-enhancing T2-FLAIR lesions that need to be
surgically resected and are likely WHO grade II glioma.

- Surgical resection of at least 0.5 grams of tumor

- Both newly diagnosed (with available pathological diagnosis) and recurrent patients
can be eligible. Prior radiation therapy (RT) after the initial diagnosis will be
allowed but there must be at least 6 months from the completion of RT (or
radiosurgery) to signed informed consent.

- Prior chemotherapy and any systemic molecularly targeted anti-tumor therapy will be

- Patients must have a Karnofsky performance status (KPS) of = 70%.

- Off or low dose (= 4 mg/day by Decadron) corticosteroid at least two weeks before the
first pre-surgical vaccine

- Adequate organ function within 14 days of study registration including: 1) Adequate
bone marrow reserve: absolute neutrophil (segmented and bands) count (ANC) =1.0 x
10^9/L, absolute lymphocytes =400/µL, platelets =100 x 10^9/L; hemoglobin = 8 g/dL; 2)
Hepatic: - Total bilirubin = 1.5 x upper limit of normal (ULN) and SGPT (ALT) = 2.5 x
upper limit of normal (ULN), and 3) Renal: Normal serum creatinine or creatinine
clearance =60 ml/min/1.73 m^2

- Must be free of systemic infection. Subjects with active infections (whether or not
they require antibiotic therapy) may be eligible after complete resolution of the
infection. Subjects on antibiotic therapy must be off antibiotics for at least 7 days
before beginning treatment.

- Sexually active females of child bearing potential must agree to use adequate
contraception (diaphragm, birth control pills, injections, intrauterine device [IUD],
surgical sterilization, subcutaneous implants, or abstinence, etc.) for the duration
of the vaccination period. Sexually active males must agree to use barrier
contraceptive for the duration of the vaccination period.

- Patient must sign an informed consent document indicating that they are aware of the
investigational nature of this study, which includes an authorization for the release
of their protected health information

Exclusion Criteria:

- Presence of gliomatosis cerebri, cranial or spinal leptomeningeal metastatic disease

- Presence of T1 Gadolinium (Gd)-enhancing lesions (on MRI) suggestive of high-grade

- Pathological diagnosis for the resected tumor demonstrates transformation to higher
grade (i.e. WHO grade III or IV) or gliomas. If a patient who received pre-surgical
vaccines is diagnosed as high-grade glioma (HGG), the patient will be withdrawn from
the study and considered for therapeutic options for HGG (trials for HGG or standard
of care). The tumor tissue of such a case would be brought to the lab before the
pathological diagnosis is made; and thus would be processed before the lab is informed
of the final HGG diagnosis. Because HGG tissue may still reflect the vaccine effects,
we will evaluate the tumor tissue to help us develop future approaches for HGG.

- Pregnant women are excluded from this study. Pregnancy testing will be performed on
all menstruating females within 14 days prior to study enrollment

- Uncontrolled intercurrent illness including, but not limited to ongoing or active
infection (e.g. active or chronic hepatitis B and C), symptomatic congestive heart
failure, unstable angina pectoris, or psychiatric illness/social situations that would
limit compliance with study requirements

- History or current status of immune system abnormalities such as hyperimmunity (e.g.,
autoimmune diseases) that needed to be treated by systemic therapy, such as
immuno-suppressants and hypoimmunity (e.g., myelodysplastic disorders, marrow
failures, AIDS, transplant immunosuppression).

- Receiving ongoing treatment with immunosuppressive drugs, or dexamethasone > 4mg
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