Clinical Trial Finder

Vaccine Therapy for the Treatment of Newly Diagnosed Glioblastoma Multiforme

Study Purpose

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.

Recruitment Criteria

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Accepts Healthy Volunteers
No

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Study Type
Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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

Trial Details

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

Trial ID:
NCT02465268

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase
Phase 2

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Lead Sponsor
University of Florida

The person who is responsible for the scientific and technical direction of the entire clinical study.

Principal Investigator
Duane Mitchell, MD, PhDMaryam Rahman, MD
Principal Investigator Affiliation University of FloridaUniversity of Florida

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Agency Class
OtherNIH
Overall Status Recruiting
Countries United States

The disease, disorder, syndrome, illness, or injury that is being studied.

Conditions
Glioblastoma Multiforme, Glioblastoma, Malignant Glioma, Astrocytoma, Grade IV, GBM
Additional Details

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

University of Florida, Gainesville, Florida

Status

Recruiting

Address

University of Florida

Gainesville, Florida, 32610

Site Contact

Phuong Deleyrolle, RN

phuong.deleyrolle@neurosurgery.ufl.edu

352-273-5529

Orlando Health, Orlando, Florida

Status

Recruiting

Address

Orlando Health

Orlando, Florida, 32806

Site Contact

Carolina Manchola-Orozco

Carolina.Manchola-Orozco@orlandohealth.com

321-841-7293

Duke University Medical Center, Durham, North Carolina

Status

Active, not recruiting

Address

Duke University Medical Center

Durham, North Carolina, 27710

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