Clinical Trial Details
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NCT02549833 : Neo-adjuvant Evaluation of Glioma Lysate Vaccines in WHO Grade II Glioma
PhasePhase 1
AgesMin: 18 Years Max: N/A
Inclusion Criteria:

- Pathological criteria - Patients must have newly diagnosed or recurrent WHO grade II
glioma (defined as an astrocytoma, oligodendroglioma, or oligoastrocytoma) that is to
be histologically confirmed by clinically indicated resection. If patients have
already undergone biopsy and have pathological diagnosis of WHO grade II glioma,
pathology must be reviewed and confirmed at UCSF.

- Before enrollment, patients must show supratentorial, non-enhancing T2-FLAIR lesions
that need to be surgically resected and are likely WHO grade II glioma. Surgical
resection of at least 500 mg tumor tissue to ensure adequate evaluation of the study

- Prior radiation therapy (RT) after the initial diagnosis will be allowed. Patients
with prior RT must be at least 6 months from the completion of RT (or radiosurgery)

- Prior chemotherapy or molecularly targeted therapy will be allowed. Patients with
prior chemotherapy must be at least 6 months from the last dose of chemotherapy or
molecularly targeted therapy

- Patients must be = 18 years old

- Patients must have a Karnofsky performance status = 70%

- Patients must be off corticosteroid for at least for 2 weeks before the first
neoadjuvant vaccine and for at least 2 weeks prior to the first adjuvant vaccine

- Adequate organ function within 14 days of study registration including:

- Adequate bone marrow reserve: absolute neutrophil (segmented and bands) count
(ANC) =1.0 x 10^9/L; absolute lymphocyte count (ALC) =0.5 x 10^9/L; platelets
=100 x 10^9/L; hemoglobin =8 g/dL;

- Hepatic: - Total bilirubin =1.5 x upper limit of normal (ULN) and SGPT (ALT) =
2.5 x upper limit of normal (ULN), and

- 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.

Exclusion Criteria:

- History of immune system abnormalities such as hyperimmunity (e.g., autoimmune
diseases) and hypoimmunity (e.g., myelodysplastic disorders, marrow failures, AIDS,
transplant immunosuppression)

- History or clinical suspicion of neurofibromatosis

- Any isolated laboratory abnormality suggestive of a serious autoimmune disease (e.g.

- Any conditions that could potentially alter immune function (AIDS, multiple sclerosis,
uncontrolled diabetes, renal failure)

- Receiving ongoing treatment with immunosuppressive drugs

- Currently receiving any investigational agents or registration on another therapy
based trial

- Pregnant or lactating
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