PEP-CMV in Recurrent MEdulloblastoma/Malignant Glioma (PRiME)
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|ClinicalTrials.gov Identifier: NCT03299309|
Recruitment Status : Suspended (Delay in vialing of study vaccine)
First Posted : October 3, 2017
Last Update Posted : May 25, 2021
|Condition or disease||Intervention/treatment||Phase|
|Recurrent Medulloblastoma Recurrent Brain Tumor, Childhood Malignant Glioma||Drug: PEP-CMV||Phase 1|
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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||The PRiME Study: PEP-CMV in Recurrent MEdulloblastoma/Malignant Glioma|
|Actual Study Start Date :||June 29, 2018|
|Estimated Primary Completion Date :||December 2021|
|Estimated Study Completion Date :||December 2023|
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 Name: PEP-CMV vaccine
- 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
- Mean or median change from baseline at each follow-up assessment in ELISPOT (IFN-γ) [ Time Frame: 24 months ]Quantitate the immune response to the components of the PEP-CMV vaccine by ELISPOT
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03299309
|United States, North Carolina|
|Duke University Medical Center|
|Durham, North Carolina, United States, 27710|
|Principal Investigator:||Eric Thompson, MD||Duke University|
|Principal Investigator:||Daniel S Landi, MD||Duke University|