Phase I Trial of Vaccination with Autologous Dendritic Cells Pulsed with Lysate

Condition/Intervention:

  • Brain tumors

Study Name:

A Phase I Trial of Vaccination with Autologous Dendritic Cells Pulsed with Lysate Derived from an Allogeneic Glioblastoma Stem-like Cell Line for Patients with Newly Diagnosed or Recurrent Glioblastoma

Summary:

This study is designed to assess an investigational dendritic cell (DC) vaccine in patients with glioblastoma, a type of brain tumor. The goal is for the vaccine to cause the body to recognize that tumor cells are foreign and to produce its own immune response, thereby fighting off tumor cells. The study utilizes a special component of patients’ white blood cells that has been processed by the research lab to make the vaccine.

Key Inclusion Criteria:

  • Newly diagnosed glioblastoma (Group A), or glioblastoma at first–third recurrence (Group B)
  • Complete resection of tumor. The qualifying surgical resection must have been performed at Cedars-Sinai in order to allow for tumor stem cell antigen testing.
  • 18 years of age or older
  • Able to care for self
  • Female patients of child bearing potential must have negative pregnancy test
  • Signed informed consent

Key Exclusion Criteria:

  • Prior placement of intracavitary BCNU-impregnated wafers (Gliadel)
  • Presence of any other active malignancy or prior history of malignancy, except for basal cell carcinoma of the skin, cervical carcinoma in situ, and early stage prostate carcinoma not requiring active treatment
  • Severe pulmonary, cardiac or other systemic disease
  • Severe or chronic medical or psychiatric condition
  • Breastfeeding females

Please see complete list of inclusion and exclusion criteria.

Principal Investigator:

Jethro Hu, MD

Co-Investigators:

Jeremy Rudnick, MD
Ray Chu, MD
Chirag Patil, MD

Study Coordinator and Contact:

Main line: 310-423-8100

Cherry Sanchez, BSN, RN
Phone: 310-423-6839
Email: cherry.sanchez@cshs.org

Nancy Barahona
Phone: 424-315-4498
Email: nancy.barahona@cshs.org

Status:

Enrolling

IRB No.:

33203

More information

Date Last Updated:

02/15