• Return to search results
• Start new search

Investigator(s):
Steven A. Rosenberg, M.D., Ph.D. Principal Investigator Phone: 1-866-820-4505 (Toll Free) ncisbirc@mail.nih.gov
Referral Contact(s):
June A. Kryk, R.N. Research Nurse Phone: 1-866-820-4505 (Toll Free) Fax: 301-451-1927 ncisbirc@mail.nih.gov	Linda Williams, R.N. Research Nurse Phone: 1-866-820-4505 (Toll Free) Fax: 301-451-1927 ncisbirc@mail.nih.gov

---

Key Eligibility Criteria:

• Diagnosis of histologically proven glioblastoma that express EGFRvIII as assessed by IHC or PCR
• Progression of disease after radiotherapy (including patients who undergo surgery for recurrent disease and are rendered NED); this includes recurrent GBM after receiving all standard first-line treatment, including surgery (if feasible due to neurosurgical and neuro-anatomical considerations) and adjuvant radiotherapy +/- chemotherapy
• ≥ 18 years of age
• Karnofsky performance status ≥ 60
• No concurrent major medical illnesses or any form of immunodeficiency
• Not receiving steroids or on a stable dose of steroids for at least five days prior to registration

---

Study Outline:

• Screening physical examination; blood and tumor samples; and imaging studies to determine eligibility for the study
• Patients undergo leukapheresis to obtain certain types of blood cells
• These cells are genetically modified to make anti-EGFRvIII cells, and the cells are grown in the laboratory
• Admission to the NIH Clinical Center to begin treatment with a non-myeloablative lymphocyte depleting preparative regimen of cyclophosphamide and fludarabine
• After completion of the preparative regimen, patients will receive the infusion of anti-EGFRvIII cells and then begin high-dose aldesleukin every 8 hours for up to 15 doses
• Return to the clinic for follow-up exams with blood tests, imaging studies, and other exams approximately 4 weeks after the initial treatment regimen. If the patient has stable disease or tumor shrinkage, repeat complete evaluations will be performed monthly for 12 months, and then every 1-2 months until off-study criteria are met

---

Additional Information:

• This trial will be conducted at the NIH Clinical Center in Bethesda, MD. It is open to patients who meet the eligibility requirements, regardless of where they live in the United States.
• There is no charge for medical care received at NIH Clinical Center.
• PDQ (Physicians Data Query) - provides additional details about this study for health care providers.

Reviewed: 12/14/12
Updated: 5/11/12