Clinical Trial Details
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NCT00045968 : Study of a Drug [DCVax®-L] to Treat Newly Diagnosed GBM Brain Cancer
PhasePhase 3
AgesMin: 18 Years Max: 70 Years
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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