Study of a Drug [DCVax®-L] to Treat Newly Diagnosed GBM Brain Cancer

Status unconfirmed · Phase 3 · Has a placebo group

Conditions studied: Glioblastoma Multiforme, Glioblastoma, GBM, Grade IV Astrocytoma, Glioma, Brain Cancer, Brain Tumor

In brief

The primary purpose of the study is to determine the efficacy of an investigational therapy called DCVax(R)-L in patients with newly diagnosed GBM for whom surgery is indicated. Patients must enter screening at a participating site prior to surgical resection of the tumor. Patients will receive the standard of care, including radiation and Temodar therapy and two out of three will additionally receive DCVax-L, with the remaining one third receiving a placebo. All patients will have the option to receive DCVax-L in a crossover arm upon documented disease progression. (note: DCVax-L when used for patients with brain cancer is sometimes also referred to as DCVax-Brain)

Key facts

Study ID

NCT00045968

Run by

Northwest Biotherapeutics

People needed

348

Starts

2006-12-01

Last updated by the study team

2022-05-18

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

Where it is running

• University of Arkansas for Medical Sciences — Little Rock, Arkansas, United States
• Sutter East Bay Neuroscience Institute-Eden Medical Center — Castro Valley, California, United States
• City of Hope — Duarte, California, United States
• UCSD Moores Cancer Center — La Jolla, California, United States
• Kaiser Permanente - Los Angeles — Los Angeles, California, United States
• UCLA Medical Center — Los Angeles, California, United States
• Hoag Memorial Hospital Presbyterian — Newport Beach, California, United States
• St. Joseph Hospital of Orange — Orange, California, United States
• University of California, Irvine Medical Center — Orange, California, United States
• Kaiser Permanente - Redwood City — Redwood City, California, United States
• Sutter Institute for Medical Research — Sacramento, California, United States
• University of Colorado Cancer Center — Aurora, Colorado, United States
• Colorado Neurological Institute — Englewood, Colorado, United States
• Georgetown University Medical Center — Washington D.C., District of Columbia, United States
• University of Florida — Gainesville, Florida, United States
• Memorial Cancer Institute — Hollywood, Florida, United States
• Mount Sinai Community Clinical Oncology Program — Miami Beach, Florida, United States
• Moffitt Cancer Center — Tampa, Florida, United States
• Piedmont Atlanta Hospital — Atlanta, Georgia, United States
• Rush University Medical Center — Chicago, Illinois, United States
• Illinois Cancer Care — Peoria, Illinois, United States
• Cadence Cancer Center — Warrenville, Illinois, United States
• IU Simon Cancer Center — Indianapolis, Indiana, United States
• University of Kansas Cancer Center — Westwood, Kansas, United States
• University of Alabama at Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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