Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02465268
Other study ID # IRB201400697-N
Secondary ID R01CA175517OCR14
Status Completed
Phase Phase 2
First received
Last updated
Start date August 9, 2016
Est. completion date November 30, 2023

Study information

Verified date March 2024
Source University of Florida
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

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

Study Design


Intervention

Biological:
pp65-shLAMP DC with GM-CSF

unpulsed PBMC and saline

Drug:
Td
All subjects will receive a Td booster before study drug dose #1. Subjects in the experimental arms will receive Td skin prep before study drug doses #3, #6, and #9.
Saline

Biological:
pp65-flLAMP DC with GM-CSF


Locations

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

Sponsors (2)

Lead Sponsor Collaborator
University of Florida National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

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
See also
  Status Clinical Trial Phase
Recruiting NCT05664243 - A Phase 1b / 2 Drug Resistant Immunotherapy With Activated, Gene Modified Allogeneic or Autologous γδ T Cells (DeltEx) in Combination With Maintenance Temozolomide in Subjects With Recurrent or Newly Diagnosed Glioblastoma Phase 1/Phase 2
Completed NCT02768389 - Feasibility Trial of the Modified Atkins Diet and Bevacizumab for Recurrent Glioblastoma Early Phase 1
Recruiting NCT05635734 - Azeliragon and Chemoradiotherapy in Newly Diagnosed Glioblastoma Phase 1/Phase 2
Completed NCT03679754 - Evaluation of Ad-RTS-hIL-12 + Veledimex in Subjects With Recurrent or Progressive Glioblastoma, a Substudy to ATI001-102 Phase 1
Completed NCT01250470 - Vaccine Therapy and Sargramostim in Treating Patients With Malignant Glioma Phase 1
Terminated NCT03927222 - Immunotherapy Targeted Against Cytomegalovirus in Patients With Newly-Diagnosed WHO Grade IV Unmethylated Glioma Phase 2
Recruiting NCT03897491 - PD L 506 for Stereotactic Interstitial Photodynamic Therapy of Newly Diagnosed Supratentorial IDH Wild-type Glioblastoma Phase 2
Active, not recruiting NCT03587038 - OKN-007 in Combination With Adjuvant Temozolomide Chemoradiotherapy for Newly Diagnosed Glioblastoma Phase 1
Completed NCT01922076 - Adavosertib and Local Radiation Therapy in Treating Children With Newly Diagnosed Diffuse Intrinsic Pontine Gliomas Phase 1
Recruiting NCT04391062 - Dose Finding for Intraoperative Photodynamic Therapy of Glioblastoma Phase 2
Active, not recruiting NCT03661723 - Pembrolizumab and Reirradiation in Bevacizumab Naïve and Bevacizumab Resistant Recurrent Glioblastoma Phase 2
Active, not recruiting NCT02655601 - Trial of Newly Diagnosed High Grade Glioma Treated With Concurrent Radiation Therapy, Temozolomide and BMX-001 Phase 2
Completed NCT02206230 - Trial of Hypofractionated Radiation Therapy for Glioblastoma Phase 2
Completed NCT03493932 - Cytokine Microdialysis for Real-Time Immune Monitoring in Glioblastoma Patients Undergoing Checkpoint Blockade Phase 1
Terminated NCT02709889 - Rovalpituzumab Tesirine in Delta-Like Protein 3-Expressing Advanced Solid Tumors Phase 1/Phase 2
Recruiting NCT06058988 - Trastuzumab Deruxtecan (T-DXd) for People With Brain Cancer Phase 2
Completed NCT03018288 - Radiation Therapy Plus Temozolomide and Pembrolizumab With and Without HSPPC-96 in Newly Diagnosed Glioblastoma (GBM) Phase 2
Not yet recruiting NCT04552977 - A Trail of Fluzoparil in Combination With Temozolomide in Patients With Recurrent Glioblastoma Phase 2
Withdrawn NCT03980249 - Anti-Cancer Effects of Carvedilol With Standard Treatment in Glioblastoma and Response of Peripheral Glioma Circulating Tumor Cells Early Phase 1
Withdrawn NCT02876003 - Efficacy and Safety of G-202 in PSMA-Positive Glioblastoma Phase 2