- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03299309
PEP-CMV in Recurrent MEdulloblastoma/Malignant Glioma (PRiME)
The PRiME Study: PEP-CMV in Recurrent MEdulloblastoma/Malignant Glioma
Study Overview
Status
Intervention / Treatment
Detailed Description
Once a patient has enrolled onto this study, prior therapy will be terminated and patients will receive temozolomide 200 mg/m2/day x 5 days. If they are receiving bevacizumab at the time of enrollment, they will continue bevacizumab 10 mg/Kg every 14 days.
Patients who are ≥ 18 years of age will receive a tetanus (Td) booster at the time of enrollment. Immunotherapy begins with a Tetanus (Td) pre-conditioning vaccine delivered intradermally (i.d.) in the right groin at the site of the vaccine injection 6-24 hours prior to the first vaccine on day 21. The PEP-CMV vaccine will be administered as follows: PEP-CMV Component A mixed with Montanide ISA-51 (1:1 volume ratio) intradermally administered half in the RIGHT groin and half in the LEFT groin.
The first 3 PEP-CMV vaccines will occur every 2 weeks, then PEP-CMV vaccines will continue monthly (+/- 2 weeks) for no more than 10 years. Blood will be obtained for immune system monitoring.
In May 2021, enrollment on the study was temporarily suspended due to delays in vialing the PEP-CMV study vaccine.
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Contact
- Name: Daniel Landi, MD
- Phone Number: 919-684-5301
- Email: pedsneuronc@duke.edu
Study Contact Backup
- Name: Laura Gorski, BSN, OCN
- Phone Number: 919-684-5301
- Email: pedsneuronc@duke.edu
Study Locations
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North Carolina
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Durham, North Carolina, United States, 27710
- Duke University Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patients who are 3 - 35 years old
- Histopathologically proven previous diagnosis of medulloblastoma or Grade III or IV glioma.
- Radiology evidence of recurrent medulloblastoma (reMB) or recurrent Grade III and IV glioma. Patients will be considered for a biopsy or resection of the recurrent/progressive tumor at the discretion of the treating neurosurgeon and neuro-oncologist.
- Brain MRI within one month prior to enrollment.
- Received prior therapy for their initial diagnosis prior to recurrence/progression or who are unable to receive radiation therapy due to genetic disorders that put them at significant risk for radiation-induced secondary malignancies (i.e. Gorlin's syndrome or NF1 mutation).
- Patients with neurological deficits should have deficits that are stable for a minimum of 2 weeks prior to registration.
- Karnofsky Performance Status (KPS) of ≥ 60% (KPS for > 10 years of age) or Lansky performance Score (LPS) of ≥ 60 (LPS for ≤ 10 years of age) assessed within 2 weeks prior to registration. Patients who are unable to walk because of paralysis but who are up in a wheel chair will be considered ambulatory for the purposes of the performance score.
Bone Marrow:
- ANC (Absolute neutrophil count) ≥ 1000/µl (unsupported)*.
- Platelets ≥ 100,000/µl (unsupported)*.
- Hemoglobin > 8 g/dL (may be supported).
Renal:
• Serum creatinine ≤ upper limit of institutional normal.
Hepatic:
- Bilirubin ≤ 1.5 times upper limit of normal for age.
- SGPT (ALT) ≤ 3 times institutional upper limit of normal for age.
- SGOT (AST) ≤ 3 times institutional upper limit of normal for age.
- Patients of childbearing or child-fathering potential must be willing to use a medically acceptable form of birth control, which includes abstinence, while being treated on this study.
- Signed informed consent according to institutional guidelines must be obtained prior to registration.
- Any prior chemoradiotherapy is allowed.
Exclusion Criteria:
- Pregnant or need to breast feed during the study period (Negative serum pregnancy test required).
- Active infection requiring treatment or an unexplained febrile (> 101.5 degrees F) illness.
- Known immunosuppressive disease or human immunodeficiency virus infection.
- Patients with active renal, cardiac (congestive cardiac failure, myocardial infarction, myocarditis), or pulmonary disease.
- Patients receiving concomitant immunosuppressive agents for medical condition.
- Patients who need definitive radiotherapy for treatment of recurrent MB or recurrent Grade III or IV glioma.
- Patients receiving any other investigational drug therapy.
- Patients on corticosteroids > 0.1 mg/Kg/day (i.e. > the maximum dose of 4 mg/day).
- Patients with any clinically significant unrelated systemic illness (serious infections or significant cardiac, pulmonary, hepatic or other organ dysfunction).
- Patients with inability to return for follow-up visits or obtain follow-up studies required to assess toxicity to therapy.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: PEP-CMV
Cytomegalovirus (CMV)-specific peptide vaccine (PEP-CMV)
|
Patients receive temozolomide (TMZ) 200 mg/m2/day x 5 days.
On day 20, patients will receive a Tetanus-diphtheria pre-conditioning vaccination with Td (tetanus, diphtheria toxoid, adsorbed).
Immunotherapy begins the following day, on day 21, with injection of the PEP-CMV vaccine as follows: PEP-CMV Component A mixed with Montanide ISA-51 intradermally administered half in the RIGHT groin and half in the LEFT groin.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Proportion of patients with unacceptable toxicity
Time Frame: 2 weeks after the 3rd PEP-CMV vaccine on the last enrolled patient
|
Evaluate the safety of PEP-CMV in pediatric patients with recurrent MB or recurrent Grade III/IV glioma
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2 weeks after the 3rd PEP-CMV vaccine on the last enrolled patient
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mean or median change from baseline at each follow-up assessment in ELISPOT (IFN-γ)
Time Frame: 24 months
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Quantitate the immune response to the components of the PEP-CMV vaccine by ELISPOT
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24 months
|
Mean or median change from baseline at each follow-up assessment in ELISA (gB-KLH)
Time Frame: 24 months
|
Quantitate the immune response to the components of the PEP-CMV vaccine by ELISA
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24 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Daniel Landi, MD, Duke University
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Disease Attributes
- Neoplasms, Neuroepithelial
- Neuroectodermal Tumors
- Neoplasms, Germ Cell and Embryonal
- Neoplasms, Nerve Tissue
- Central Nervous System Neoplasms
- Nervous System Neoplasms
- Neuroectodermal Tumors, Primitive
- Recurrence
- Glioma
- Brain Neoplasms
- Medulloblastoma
- Physiological Effects of Drugs
- Immunologic Factors
- Vaccines
Other Study ID Numbers
- Pro00079843
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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