You wrote: "FDA is leaning towards using historical data. We have discussed this for months. FDA went through a comment period for new guidelines. That would be how they answer that."
BOLLOCKS! That would be impossible concerning NWBO, too many patients excluded for various reasons in this PII/PIII trial, why do you think it took so long to complete?
Outcome Measures:
The primary objective of this study is to compare progression free survival from time of randomization between patients treated with DCVax-L and control patients.
The secondary objective is to compare overall survival and time to disease progression between DCVax-L treated and control patients.
Inclusion Criteria:
All patients must meet the following inclusion criteria. All tests and eligibility criteria must be completed within four weeks of completion of radiation and chemotherapy, following surgery.
Patients must have sufficient tumor lysate protein that was generated from the surgically obtained tumor material. Patients must also have sufficient DCVax-L product available after manufacturing. These determinations will be made by Cognate BioServices, Inc. (Cognate) and communicated to the clinical site through the Sponsor, or its designee.
Patients with newly diagnosed, unilateral GBM (Grade IV) are eligible for this protocol. An independent neuropathologist will review this diagnosis during the enrollment process.
Subjects =18 and =70 years of age at surgery who are capable of informed consent. Patients must be able to understand and sign the informed consent documents indicating that they are aware of the investigational nature of this study.
Patients must have a life expectancy of >8 weeks.
Patients must have a KPS rating of =70 at the baseline visit (Visit 3).
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. These primary treatments must be completed at least two weeks prior to first immunization.
Patients may have received steroid therapy as part of their primary treatment. Steroid treatment must be stopped at least 10 days prior to leukapheresis.
Patients must not have progressive disease at completion of radiation therapy. Patients with suspected pseudoprogression will be enrolled and analyzed separately.
Patients must be willing to forego cytotoxic anti-tumor therapies except temozolomide essentially according to the schedule of the Stupp Protocol (Stupp et al. N Engl J Med 352: 987-96, 2005) while being treated with DCVax-L. DCVax-L treatment must be given as described and temozolomide/Temodar treatment schedules must be given essentially according to the Stupp Protocol.
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.
Adequate liver function (SGPT, SGOT, and alkaline phosphatase =1.5 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.
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