Protocol Number: 09-C-0038

Title:

ATTAC: Anti-Tumor Immunotherapy Targeted Against Cytomegalovirus in Patients with Newly Diagnosed Glioblastoma Multiforme During Recovery from Therapeutic Temozolomide-induced Lymphophenia

Number:

09-C-0038

Summary:

Background:

-The vaccine used in this study, called DC CMV pp65, is made from special immune cells called DCs, which are made using the patient's own white blood cells.

-The DCs contain genetic material that instructs the cells to make a protein called CMV that is found in the patient's tumor.

Objectives:

-To learn if the DC vaccine can help activate the patient's immune system against the CMV protein and stimulate it to fight the brain tumor cells.

Eligibility:

-Adult patients with a newly diagnosed glioblastoma multiforme tumor.

Design:

-Patients continue treatment with Avastin and temozolomide (TMZ)

-Patients undergo apheresis to collect white blood cells for use in making the vaccine. For this procedure, a catheter is inserted into a vein in each arm. Blood flows from one arm into a machine that separates and extracts the white cells, and the rest of the blood is returned to the patient through the catheter in the other arm.

-Patients receive three vaccine injections - one every 2 weeks for the first 6 weeks of the study. The vaccine is injected just under the skin on both sides of the groin.

-Patients have follow-up visits for the following procedures:

-Review of side effects or symptoms

-Blood draw to check kidney function and immune function

-Brain MRI to assess tumor

-Treatment may continue until the Avastin and TMZ no longer control the tumor or treatment side effects are no longer tolerable.

Sponsoring Institute:

National Cancer Institute (NCI)

Recruitment Detail

Type: No longer recruiting/follow-up only

Gender: Male & Female

Referral Letter Required: No

Population Exclusion(s): Children

Eligibility Criteria: This study is not currently recruiting new subjects. If you have questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.

Special Instructions:

Currently Not Provided

Keyword(s):

Glioblastoma

Radiation Therapy

Chemotherapy

Progression

Brain Tumor

Recruitment Keyword(s):

None

Condition(s):

Glioblastoma Multiforme

Investigational Drug(s):

Human Cytomegalovirus pp65-lyosomal-associated protein mRNA-pulsed autologous DC

Investigational Device(s):

None

Interventions:

Drug: Human Cytomegalovirus pp65-lyosomal-associated protein mRNA-pulsed autologous DC

Supporting Site:

National Cancer Institute

Contact(s):

This study is not currently recruiting new subjects. If you have questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.

Citation(s):

Adler SP, Hempfling SH, Starr SE, Plotkin SA, Riddell S. Safety and immunogenicity of the Towne strain cytomegalovirus vaccine. Pediatr Infect Dis J. 1998 Mar;17(3):200-6.

Adler SP, Shaw KV, McVoy M, Burke RL, Liu H. Guinea pig and human cytomegaloviruses do not share cross-reactive neutralizing epitopes. J Med Virol. 1995 Sep;47(1):48-51.

Albright L, Seab JA, Ommaya AK. Intracerebral delayed hypersensitivity reactions in glioblastoma multiforme patients. Cancer. 1977 Mar;39(3):1331-6.

• Questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.
• Technical questions regarding the Clinical Center web site, please contact the Department Clinical Research Informatics, CC.

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