Protocol No.: OCR14127
Sponsor Protocol No.: 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
The purpose of this research study is to determine if an investigational dendritic cell vaccine, called pp65 DC, is effective for the treatment of a specific type of brain tumor called glioblastoma (GBM) when given with stronger doses of routine chemotherapy.
Dendritic cells (DC) are involved in activating, or turning-on, your body's immune system. Your immune system helps guard your body from germs, viruses, and other threats. Although dendritic cells are very strong, the number of them in the body is not high enough to cause a powerful immune response; therefore, more DC are made in a laboratory with cells collected from an individual's blood.
In this study, we will make a vaccine that we hope will educate immune cells to target the pp65 antigen, a type of immune marker in GBM, thus resulting in what we call the pp65 DC vaccine. Use of a vaccine that activates your immune system is a type of immunotherapy. It is hoped that by giving the pp65 DC vaccine as a shot under the skin, the immune system will be activated to attack tumor cells in the brain while leaving normal cells alone.
To see if the pp65 DC vaccine is effective for the treatment of GBM, subjects will be assigned to different treatment groups. Two groups of subjects will receive the pp65 DC vaccine and one group will receive a placebo.
Phase: Phase II
Age Group: Adult
Given under the skin at day 22-24 after the first temozolomide cycle then at 2 week intervals. Doses 4-10 will be given on day 22-24 of each temozolomide cycle. Doses will continue until a total of 10 or until progression or unacceptable toxicity.
1. Ages 18 years old and older
2. Histopathologically proven newly-diagnosed de novo GBM (secondary GBM not eligible).
3. CMV seropositive.
4. The tumor must have a supratentorial component.
5. Must have undergone definitive surgical resection of tumor with less than 1cm x 1cm residual enhancing tumor in longest perpendicular planes by MRI.
6. Recovery from the effects of surgery, postoperative infection, and other complications.
7. Diagnostic contrast-enhanced MRI or CT scan of the brain preoperatively and postoperatively.
8. Karnofsky Performance Status of ≥ 70.
9. Signed informed consent.
10. For females of childbearing potential, negative serum pregnancy test.
11. Women of childbearing potential and male participants must be willing to practice adequate contraception.
1. Prior invasive malignancy unless disease free for ≥ 3 years.
2. Metastases detected below the tentorium or beyond the cranial vault and leptomeningeal involvement.
3. Recurrent or multifocal malignant gliomas.
4. HIV, Hepatitis B, or Hepatitis C seropositive.
5. Known active infection or immunosuppressive disease.
6. Prior chemotherapy or radiosensitizers (including Gliadel wafers) for cancers of the head and neck region.
7. Prior radiotherapy to the head or neck, resulting in overlap of radiation fields.
8. Severe, active co-morbidity.
9. Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception.
10. Pregnant or lactating women.
11. Prior allergic reaction to temozolomide, GM-CSF or Td.
12. Prior history of brachial neuritis or Guillain-Barré syndrome.
13. Patients treated on any other therapeutic clinical protocols within 30 days prior to study entry.
** Contact study team for full listing of Inclusion/Exclusion crtiera
Applicable Disease Sites
Brain and Nervous System
UF Health Cancer Center at Orlando Health
View study listing on ClinicialTrials.gov