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Clinical Trials
A Phase II Clinical Trial Evaluating DCVax®-Brain, Autologous Dendritic Cells Pulsed with Tumor Lysate Antigen for the Treatment of Glioblastoma Multiforme
ClinicalTrials.gov identifier: NCT00045968
UCLA IRB #: 11-000686
The purpose of the study is to determine the safety and efficacy of an investigational therapy called DCVax(R)-Brain in patients with newly diagnosed GBM for whom surgery is indicated. Patients must enter screening at UCLA prior to surgical resection of the tumor. Patients will receive standard of care, including radiation and Temodar therapy and two out of three will additionally receive DCVax-Brain and the remaining one third will receive placebo. Patients randomized to placebo will have the option to receive DCVax-Brain in a crossover arm upon documented disease progression.
In order to enroll in this trial, patients must have surgery for a newly diagnosed tumor here at UCLA prior to radiation and chemotherapy. The tumor tissue is collected and processed immediately at the time of surgery in order to make the personalized vaccine. Due to strict FDA and sterility requirements, we unfortunately cannot accept tumor tissue that has already been resected and stored at outside institutions.
View DCVax Informational Flyer (PDF), View DCVax Consent (PDF)
Phase I Clinical Trial Evaluating Cellular Immunotherapy with Intratumoral Alloreactive Cytotoxic T Lymphocytes and Interleukin-2 for the Treatment of Recurrent Malignant Gliomas
ClinicalTrials.gov identifier: NCT01144247
UCLA IRB # 11-000790
This study is being done to determine what effects, good or bad, the infusion of another person's immune system cells known as alloreactive cytotoxic T-lymphocytes (aCTL) into the brain will have on a type of malignant brain tumor known as recurrent glioma. In this Phase I study, blood cells from a healthy person (donor) are mixed with your irradiated blood cells in a specialized machine which allows the donors' blood cells to become activated into aCTLs. If you agree to participate in this study, these aCTLs will be infused into your brain when you undergo surgery to remove the recurrent tumor or later by a special access port/catheter, which is implanted in your brain and skull at the time you undergo surgery. These aCTLs will be infused into the brain cavity every other month for 10 months, along with a drug known as interleukin-2 (IL-2). It is hoped that these cells will migrate from the tumor resection cavity and kill any remaining tumor cells.
View AlloCTL Information Flyer (PDF), View AlloCTL Consent (PDF)
A Phase II Clinical Trial Evaluating Autologous Dendritic Cells Pulsed with Tumor Lysate Antigen +/- Toll-like Receptor Agonists for the Treatment of Malignant Glioma
ClinicalTrials.gov identifier: NCT01204684
UCLA IRB #: 10-000202
The primary purpose of this Phase II clinical trial is to evaluate vaccine combination based on formulations tested in the Phase I clinical trial. The previous Phase I clinical trial already confirmed that the vaccine is safe in patients. Other goals of this study are to determine if the vaccine can cause an immune response against your cancer cells and slow the growth of your brain tumor. The vaccine immunizations will consist of two separate intra-dermal injections into the upper arm. Each patient will be randomized into one of three treatment groups. For patients that randomized to treatment group A, the vaccine with a placebo will be given. The placebo will either be a placebo cream or a placebo intramuscular injection of saline. For patients that randomize to treatment group B, vaccinations will be given with a topical immune-enhancing cream (0.2% resiquimod cream). For patients that randomize to treatment group C, vaccinations will be given with a one-time intramuscular injection of an immune-enhancing agent (poly-ICLC (Hiltonol®)).
Phase I Dose Escalation Study of Autologous Tumor Lysate-Pulsed Dendritic Cell Immunotherapy for Malignant Gliomas
ClinicalTrials.gov identifier: NCT00068510
IRB #: 10-000417
The purpose of the study is to determine the safety of an immune cell-based vaccine for brain cancer. Other goals of the study are to test whether the study vaccine causes an immune response against your cancer cells.
View Journal Article from Phase I Dendritic Cell Vaccine Clinical Trial (PDF)
For further information, please contact:
Emma L. Young, R.N. at (310) 267-2621 or ELyoung@mednet.ucla.edu
