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Glioblastoma Multiforme - Healing Genes
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Glioblastoma Multiforme

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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


Phase 2

DESCRIPTION:

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
  • Glioblastoma
  • Malignant Glioma
  • Astrocytoma, Grade IV
  • GBM

A portion of participants will receive placebo vaccines, and follow up will last up to 24 months.


PATIENT MUST:

  • 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:

  1. Screening before the treatment
  2. A course of chemotherapy prior to first Tetanus/Diphteria booster
  3. 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
  4. 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]

 

SPONSOR INFORMATION:

University of Florida

National Cancer Institute (NCI)

 

Or go online:

https://clinicaltrials.gov/ct2/show/NCT02465268

 

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