Clinical Trials Logo

Clinical Trial Summary

The primary goal of this prospective clinical trial is to evaluate the safety of PEP-CMV in patients with recurrent medulloblastoma and malignant glioma. Patients with histologically-proven medulloblastoma or malignant glioma who had received prior therapy for their initial diagnosis and subsequently had tumor recurrence/progression may be enrolled any time after recurrence/progression regardless of prior adjuvant therapy. PEP-CMV is a vaccine comprised of Component A, a synthetic long peptide (SLP) of 26 amino acid residues from human pp65. In May 2021, enrollment on the study was temporarily suspended due to delays in vialing the PEP-CMV study vaccine.


Clinical Trial 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 Design


Related Conditions & MeSH terms


NCT number NCT03299309
Study type Interventional
Source Duke University
Contact
Status Active, not recruiting
Phase Phase 1
Start date June 29, 2018
Completion date April 2025

See also
  Status Clinical Trial Phase
Terminated NCT02764151 - First in Patient Study for PF-06840003 in Malignant Gliomas Phase 1
Completed NCT02526017 - Study of Cabiralizumab in Combination With Nivolumab in Patients With Selected Advanced Cancers Phase 1
Completed NCT00953121 - Bevacizumab Plus Irinotecan Plus Carboplatin for Recurrent Malignant Glioma (MG) Phase 2
Completed NCT00766467 - A Randomized Placebo-Controlled Trial of Armodafinil (Nuvigil) for Fatigue in Patients With Malignant Gliomas Phase 2
Active, not recruiting NCT03233204 - Olaparib in Treating Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With Defects in DNA Damage Repair Genes (A Pediatric MATCH Treatment Trial) Phase 2
Recruiting NCT05045027 - Simultaneous Multinuclear Metabolic MRI in Newly Diagnosed or Recurrent Glioma Early Phase 1
Completed NCT02507583 - Antisense102: Pilot Immunotherapy for Newly Diagnosed Malignant Glioma Phase 1
Completed NCT04109209 - Psychological Intervention For Brain Tumor Caregivers N/A
Recruiting NCT04937413 - The PCSK9i Inhibitor Evolocumab - a Surgical Trial of Pharamcodynamics and Kinetics Evaluation Early Phase 1
Completed NCT03615404 - Cytomegalovirus (CMV) RNA-Pulsed Dendritic Cells for Pediatric Patients and Young Adults With WHO Grade IV Glioma, Recurrent Malignant Glioma, or Recurrent Medulloblastoma Phase 1
Active, not recruiting NCT04175301 - Effect H2 Water on QoL of Patients Receiving Radiotherapy for High Grade Gliomas. Phase 2
Terminated NCT02659800 - Study of the Effect NT-I7 on CD4 Counts in Patients With High Grade Gliomas Phase 1
Active, not recruiting NCT02323880 - Selinexor in Treating Younger Patients With Recurrent or Refractory Solid Tumors or High-Grade Gliomas Phase 1
Completed NCT00782756 - Bevacizumab, Temozolomide and Hypofractionated Radiotherapy for Patients With Newly Diagnosed Malignant Glioma Phase 2
Terminated NCT02855086 - Cetuximab-IRDye 800CW in Detecting Tumors in Patients With Malignant Glioma Undergoing Surgery Phase 1/Phase 2
Completed NCT02861222 - Myocet® in Children With Relapsed or Refractory Non-brainstem Malignant Glioma Phase 1
Completed NCT00634231 - A Phase I Study of AdV-tk + Prodrug Therapy in Combination With Radiation Therapy for Pediatric Brain Tumors Phase 1
Completed NCT01792505 - Dendritic Cell Vaccine With Imiquimod for Patients With Malignant Glioma Phase 1
Completed NCT00190723 - A Study of LY317615 in Patients With Brain Tumors Phase 2
Recruiting NCT04323046 - Immunotherapy Before and After Surgery for Treatment of Recurrent or Progressive High Grade Glioma in Children and Young Adults Phase 1