Glioblastoma Clinical Trial
— ATTAC-IIOfficial title:
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
Verified date | March 2024 |
Source | University of Florida |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 175 |
Est. completion date | November 30, 2023 |
Est. primary completion date | November 30, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Abbreviated Inclusion Criteria: To be assessed at study enrollment prior to standard of care chemo-radiation therapy: - Age = 18 years. - Histopathologically proven newly-diagnosed de novo GBM (WHO Grade IV glioma) - The tumor must have a supratentorial component. - Must have undergone definitive surgical resection of tumor with less than approximately 3cm x 3cm residual enhancing tumor as product of longest perpendicular planes by MRI. - Recovery from the effects of surgery, postoperative infection, and other complications. - Diagnostic contrast-enhanced MRI or CT scan of the brain preoperatively and postoperatively. - Karnofsky Performance Status of = 70. - Signed informed consent. - For females of childbearing potential, negative serum pregnancy test. - Women of childbearing potential and male participants must be willing to practice adequate contraception throughout the study and for at least 24 weeks after the last dose of study drug. To be assessed prior to initiation of adjuvant TMZ: - Must have completed RT (targeted total dose of 59.4-60.0 Gy over = 7 weeks) and concomitant TMZ (targeted dose of 75mg/m2/d for = 49 days) therapy without significant toxicity that persisted over 4 weeks. - History & physical with neurologic examination prior to initiation of adjuvant TMZ. - For patients receiving steroids, daily dose must be = 4 mg. - CBC with differential with adequate bone marrow function. - Adequate renal function. - Adequate hepatic function. Abbreviated Exclusion Criteria: To be verified in order to randomize subject: - Prior invasive malignancy unless disease free for = 3 years. - Metastases detected below the tentorium or beyond the cranial vault and leptomeningeal involvement. - Recurrent or multifocal malignant gliomas. - HIV, Hepatitis B, or Hepatitis C seropositive. - Known active infection or immunosuppressive disease. - Prior chemotherapy or radiosensitizers (including Gliadel wafers) for cancers of the head and neck region. - Prior radiotherapy to the head or neck, resulting in overlap of radiation fields. - Severe, active co-morbidity. - Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception for the entire study period. - Pregnant or lactating women. - Prior allergic reaction to temozolomide, GM-CSF or Td. - Prior history of brachial neuritis or Guillain-Barré syndrome. - Patients treated on any other therapeutic clinical protocols within 30 days prior to study entry. To be assessed prior to initiation of adjuvant TMZ: - Did not start radiation therapy and temozolomide within 7 weeks of surgery. - Progression of disease as defined by modified RANO criteria. - More than 45 days after completion of radiation therapy and temozolomide |
Country | Name | City | State |
---|---|---|---|
United States | Duke University Medical Center | Durham | North Carolina |
United States | University of Florida | Gainesville | Florida |
United States | Orlando Health | Orlando | Florida |
Lead Sponsor | Collaborator |
---|---|
University of Florida | National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in median overall survival | From date of randomization until the date of death, assessed up to 24 months | ||
Secondary | Changes in immune response | Parameters include ELISPOT for evaluation of cellular immune responses is a sensitive detection assay for evaluation of antigen specific cytokine producing T cells | Change between baseline and vaccine #3, assessed up to 4 weeks | |
Secondary | Change in progression-free survival | From randomization until first documentation of either disease progression or recurrence assessed up to 24 months | ||
Secondary | Changes in immune response | Parameters include peak antibody titers to the CMV pp65, reported as humoral response to the specific antigens. | Change between baseline and vaccine #3, assessed up to 4 weeks | |
Secondary | Changes in immune response | Parameters include Cytokine Bead Array analysis to detect multiple cytokines secreted by lymphocytes after in vitro stimulation with specific and control antigens, examine the spectrum of Type 0,1,2, and 3 cytokines secreted by T cells after stimulation with overlapping peptides spanning CMV pp65, PHA, and control peptides | Change between baseline and vaccine #3, assessed up to 4 weeks | |
Secondary | Changes in immune response | Parameters include cytokine flow cytometric analysis which involves the rapid early detection and analysis of the production of IFN, TNF, and IL-2 prior to cellular secretion following antigen-specific stimulation in vitro as determined by CFC | Change between baseline and vaccine #3, assessed up to 4 weeks |
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