Peptide Vaccine for Glioblastoma Against Cytomegalovirus Antigens (PERFORMANCE)
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|ClinicalTrials.gov Identifier: NCT01854099|
Recruitment Status : Withdrawn (Investigator decided not to open study.)
First Posted : May 15, 2013
Last Update Posted : January 14, 2014
|Condition or disease||Intervention/treatment||Phase|
|Glioblastoma||Biological: PEP-CMV||Phase 1|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Peptide Targets for Glioblastoma Against Novel Cytomegalovirus Antigens|
|Study Start Date :||January 2014|
|Actual Primary Completion Date :||January 2014|
|Actual Study Completion Date :||January 2014|
Active Comparator: 5 Day TMZ with PEP-CMV on Day 6-8
Standard TMZ (200 mg/m2/day x 5 days) with PEP-CMV vaccination on Day 6-8 of each monthly TMZ cycle
500 µg of PEP-CMV vaccine given intradermally on day 6-8 of each monthly TMZ cycle (standard 200 mg/m^2 x 5 days) with group 1.
Active Comparator: 5 day TMZ with vaccine on day 22-24
Standard TMZ (200 mg/m2/day x 5 days) with vaccination on Day 22-24 of each monthly TMZ cycle
500 µg of PEP-CMV vaccine given intradermally on day 22-24 of each monthly TMZ cycle (standard 200 mg/m^2 x 5 days) with group 2.
Active Comparator: 21 day TMZ wtih vaccine on day 22-24
Dose-intensified TMZ (100 mg/m2/day x 21 days) with vaccination on day 22-24 of each monthly TMZ cycle
500 µg of PEP-CMV vaccine given intradermally on day 22-24 of each monthly TMZ cycle (dose-intensified 100 mg/m^2 x 21 days) with group 3.
- Safety [ Time Frame: 6 months ]To determine the optimal & safe peptide vaccination regimen with TMZ through dose-limiting toxicity (DLT) measurements. The primary safety assessment for DLT will be determined 1 week after the 3rd weekly vaccine. A DLT will be defined as any irreversible Grade 3 toxicity, any Grade 4 toxicity, or any life threatening-event not attributable to concomitant medication, co-morbid event, or disease progression. Initially 6 patients will be accrued to the study (2 per arm) after which accrual will be suspended to review the toxicity experienced by these patients during the first 3 weekly vaccinations. If 0 or 1 of these patients experience DLT, accrual of the remaining patients will commence. Otherwise, modifications of the protocol will be considered before accruing additional patients.
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): NCT01854099
|Principal Investigator:||Duane A Mitchell, MD, PhD||University of Florida|