Clinical Trial Details
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NCT01678352 : Imiquimod and Tumor Lysate Vaccine Immunotherapy in Adults With High Risk or Recurrent Grade II Gliomas
PhaseEarly Phase 1
AgesMin: 18 Years Max: N/A
Inclusion Criteria:

- Cohort 1 and 2: Age ?18 year old with histologically diagnosed World Health
Organization (WHO) grade II astrocytoma or oligoastrocytoma with "high-risk" factors -
defined as:

- age ? 40 with any extent resection;

- age 18-39 with incomplete resection (post-op MRI showing >1cm residual disease,
based on the maximum dimension of residual T2 or fluid-attenuated
inversion-recovery [FLAIR] abnormality from the edge of the surgical cavity
either laterally, anteroposteriorly, or superoinferiorly) or

- age 18-39 with neurosurgeon-defined gross total resection (GTR) but the tumor
size is ? 4 cm (the maximum preoperative tumor diameter, based on the axial
and/or coronal T2 or FLAIR MR images) Cohort 3: Age ?18 year old with
histologically diagnosed WHO grade II glioma with recurrence

- Karnofsky performance status ? 60%

- Clinically stable and off corticosteroids for at least 4 weeks prior to study

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

- Adequate bone marrow reserve: absolute neutrophil (segmented and bands) count
(ANC) ?1.0 x 109/L, platelets ?100 x 109/L; hemoglobin ? 8 g/dL

- Hepatic: - Total bilirubin ? 1.5 x upper limit of normal (ULN) for age and SGPT
(ALT) ? 2.5 x upper limit of normal (ULN) for age

- Renal: Normal serum creatinine or creatinine clearance ?60 ml/min/1.73 m2

Exclusion Criteria:

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

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

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

- Receiving ongoing treatment with immunosuppressive drugs, excluding those patients
requiring dexamethasone for treatment of tumor-related edema

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

- Pregnant or lactating
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