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NBIO1307   |   12-148
A Phase II Clinical Trial Evaluating DCVax®-Brain, Autologous Dendritic Cells Pulsed with Tumor Lysate Antigen for the Treatment of Glioblastoma Multiforme

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  1. Primary
    • The primary objective of this study is to compare progression free survival (PFS) between patients in the DCVax-L cohort and patients in the placebo cohort in patients with no evidence of disease progression at baseline.
  2. Secondary
    • The secondary objective is to compare OS between patients in the DCVax-L group and patients in the placebo group with no evidence of disease progression at baseline.

Inclusion Criteria
  • Determined at pre-screening
    • Subjects ≥18 and ≤70 years of age at surgery
    • Patients must be able to understand and sign the informed consent indicating that they are aware of the investigational nature of this study. The consent for tumor donation may be signed by a legally authorized representative (LAR) if allowed by the institution.
    • Patients must have a life expectancy of ≥ 8 weeks
  • Determined at or around surgery, and prior to pre-leukapheresis
    • Primary therapy must consist of surgical resection with the intent for a gross or near total resection of the contrast-enhancing tumor mass, followed by conventional external beam radiation therapy and concurrent Temodar chemotherapy. Patients having a biopsy only will be excluded.
    • Patients with newly diagnosed, unilateral GBM (Grade IV) are eligible for the protocol. An independent central neuropathologist will review this diagnosis during the enrollment process.
    • All patients must have sufficient tumor lysate protein that was generated from the surgically obtained tumor material. This determination will be made by Cognate BioServices, Inc. (Cognate) and communicated to the clinical site through the Sponsor, or its designee.
  • Determined at pre-leukapheresis
    • Patients must have adequate bone marrow function (e.g., hemoglobin >10 g/dl, white blood count 3600-11,000mm³, absolute granulocyte count ≥1,500/mm³, absolute lymphocyte count ≥1,000/mm³, and platelet count ≥100K/mm³. Eligibility level of hemoglobin can be reached by transfusion. These values are determined by a central laboratory (Mayo Central Labs).
    • Adequate liver function (SGPT, SGOT, and alkaline phosphatase ≤4.0 times upper limits of normals (ULN) and total bilirubin ≤1.5mg/dl), and adequate renal function (BUN or creatinine ≤1.5 times ULN) prior to starting therapy. These values are determined by a central laboratory (Mayo Central Labs).
  • Determined at baseline
    • Patients must have a KPS rating of ≥70 at the Baseline Visit (Visit 5) (refer to Appendix F, Performance Status Scales).
    • Patients may have received steroid therapy as part of their primary treatment. Steroid treatment must preferably be stopped; or if continued steroid use is clinically indicated, be tapered down to 2-4 mg dexamethasone qd at least 7 days prior to the first immunization.
    • Patients must be willing to forego cytotoxic anti-tumor therapies except temozolomide while being treated with study drug. DCVax-L and placebo must be given as described and temozolomide must be given essentially according to the Stupp Protocol (see Appendices B and C for temozolomide schedules and detailed treatment guidelines).
    • A minimum of 5 immunizations must be available for treatment as determined by the contracted manufacturer.

Exclusion Criteria
  • Determined at pre-screening
    • History of prior malignancy except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer or other cancers that were deemed fully resolved 10 or more years prior to Visit 1 of the study.
    • History of immunodeficiency or autoimmune disease such as rheumatoid arthritis, systemic lupus erythematosus, multiple sclerosis, scleroderma, polymyositis-dermatomyositis, juvenile onset insulin dependent diabetes, or vasculitis.
    • Known HIV-1, 2, HTLV-1, 2, or Hepatitis B, C infection
    • Pregnancy
    • Inability to obtain informed consent because of psychiatric or complicating medical problems.
    • Any known genetic cancer-susceptibility syndromes.
  • Determined at or around surgery
    • Bilateral or metastatic disease detected at diagnosis, during surgery or at post-surgical magnetic resonance imaging (MRI). Tumors may cross into, but not beyond the corpus callosum.
    • Post operative MRI scan evidence of biopsy only without significant tumor resection
    • Implantation of Gliadel wafers at surgery.
  • Determined at pre-leukapheresis
    • Positive HIV-1, HIV-2, HTLV-1, hepatitis B surface antigen, or hepatitis C antibody.
    • Subjects with organ allografts.
    • Allergies to reagents used in this study.
    • Patients who are unable to stop or taper steroid treatment to less than 8mg of dexamethasone qd prior to leukapheresis are excluded from the trial; steroid use should be stopped or tapered down to the lowest clinically acceptable dose (e.g. 2 mg qd) approximately 7 days prior to the first leukapheresis.
    • Inability or unwillingness to return for required visits and follow-up exams.
    • Any previous cytotoxic drug therapies
  • Determined at or prior to baseline
    • Patients with suspicion of pseudoprogression as determined by central review are not eligible for the main arm of the study and will return at 10 weeks post completion of radiation therapy for a repeat baseline visit (Baseline 2).
    • Patients may not be taking medications that might affect immune function: The following are exceptions: nonprescription strength doses of NSAIDS, acetominophen or aspirin. A list of such medications will be provided to investigators and updated as required.
    • Patients may not have radiographic evidence of disease progression at Baseline 2 (Visit 5a) compared with the Baseline Visit MRI as determined by central review.
    • Patients with disease progression as determined by central review will not be eligible for this study.
  • Safety considerations, determined at baseline: the following exclusion criteria preclude patients from being enrolled in any arm of the study:
    • Acute infection: any active viral, bacterial, or fungal infection that requires specific therapy. Antibiotic therapy must be completed at least 7 days prior to the first immunization.
    • Active uncontrolled infection. Examples are a sexually transmitted disease (STD), herpes, uncontrolled tuberculosis, malaria, etc.
    • Fever ≥101.5 degrees Fahrenheit. If considered possibly transient, retesting is allowed.
    • Unstable or severe intercurrent medical conditions such as unstable angina, uncontrolled arythmias, Crohn's Disease, ulcerative colitis, etc.
    • Females of child-bearing potential who are pregnant or lactating or who are not using adequate contraception (surgical, hormonal or double barrier, i.e. condom and diaphragm).

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