Vaccine Therapy for the Treatment of Newly Diagnosed Glioblastoma Multiforme (ATTAC-II)
A Phase II Randomized, Blinded, and Placebo-controlled Trial of CMV RNA-Pulsed Dendritic Cells With Tetanus-Diphtheria Toxoid Vaccine in Patients With Newly-Diagnosed Glioblastoma
Researchers at the Universities in FL, NC, and the Orlando Health Center of Pennsylvania are recruiting patients with glioblastoma to test the effectiveness of a dendritic cell (DC) vaccine in combination with routine chemotherapy. DCs are rare immune cells that are unique in their ability to tell other immune cells, T-cells, to seek out tumors and attack them. The treatment will use the patient’s own DCs to multiply and prepare them to recognize their cancer in a lab before returning them to the patient via IV, along with a Tetanus/Diptheria booster that has been shown to improve DC cell activation. The following conditions may be eligible:
- Glioblastoma Multiforme
- Malignant Glioma
- Astrocytoma, Grade IV
A portion of participants will receive placebo vaccines, and follow up will last up to 24 months.
- Be 18 years of age and older
- Meet cancer screening requirements specific to the study
- Not be pregnant or breastfeeding, be willing to use contraception for the study period
THE STUDY INVOLVES:
- Screening before the treatment
- A course of chemotherapy prior to first Tetanus/Diphteria booster
- Vaccine injections under the skin 22-24 days after step (2), then at 2 week intervals with recurring cycles of chemo until their disease shows progression or they experience toxicity
- Monitoring of the patient during treatment, then follow up via lab and physical assessments for ~2 years.
LOCATIONS AND CONTACTS:
The study locations include:
University of Florida in Gainesville, FL. Map.
Orlando Health in Orlando, FL. Map.
Duke University Medical Center in Durham, NC. Map.
Contact: Nina McGrew, MSN | 352-273-5519 | [email protected]
University of Florida
National Cancer Institute (NCI)
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