IDH1 Peptide Vaccine for Recurrent Grade II Glioma (RESIST)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02193347|
Recruitment Status : Active, not recruiting
First Posted : July 17, 2014
Results First Posted : March 15, 2021
Last Update Posted : March 15, 2021
|Condition or disease||Intervention/treatment||Phase|
|Brain Cancer Brain Neoplasm, Primary Brain Neoplasms, Recurrent Brain Tumor Cancer of the Brain||Biological: PEPIDH1M vaccine Biological: Tetanus-Diphtheria Toxoid (Td) Drug: Temozolomide||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||24 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Patients With IDH1 Positive Recurrent Grade II Glioma Enrolled in a Safety and Immunogenicity Study of Tumor-Specific Peptide Vaccine|
|Actual Study Start Date :||January 28, 2016|
|Actual Primary Completion Date :||February 3, 2020|
|Estimated Study Completion Date :||December 2022|
Experimental: PEPIDH1M vaccine
PEPIDH1M vaccine is made up of a peptide that spans the mutated region of IDH1R132H (Isocitrate Dehydrogenase 1). The peptide is administered with GM-CSF (Granulocyte Macrophage Colony Stimulating Factor) mixed with Montanide ISA 51.
Biological: PEPIDH1M vaccine
PEPIDH1M vaccine is made up of 500 µg of 25 amino acid peptide administered with 150 µg of GM-CSF mixed 1:1 with Montanide ISA 51 administered intradermally. The peptide vaccine is administered in the groin area approximately 10 cm below the inguinal ligament.
Biological: Tetanus-Diphtheria Toxoid (Td)
After consent has been signed, all subjects will undergo standard of care vaccination with 0.5 mL of Td (tetanus and diphtheria toxoids adsorbed) intramuscularly (I.M.) into the deltoid muscle to ensure adequate immunity to the tetanus antigen. Within 48 hours of leukapheresis, subjects will receive a vaccine site pre-conditioning as a single dose of Td toxoid (1 flocculation unit, Lf, in a total volume of 0.4 mLs saline) administered intradermally to the right side of the groin one day prior to receiving the first PEPIDH1M vaccine.
Other Name: Tenivac
Subjects are treated with temozolomide (TMZ) at a targeted dose of 50-100mg/m2/d for 21 days every 28 days for up to 12 cycles. Subjects that have transitioned to a higher grade brain tumor at time of surgery will receive TMZ and radiation therapy per standard of care before starting TMZ cycles.
Other Name: Temodar
- Percentage of Participants With an Unacceptable Toxicity [ Time Frame: Date of consent through 2 months after the last vaccination ]The percentage of patients who experience an unacceptable toxicity defined as any Grade 3 toxicity at least possibly attributed to the vaccine (or vaccine + TMZ and/or RT) that does not resolve to baseline within 3 weeks, any Grade 3 hypersensitivity reactions requiring steroids, any Grade 4 toxicity, including neurologic events not due to progressive disease, or any life threatening-event not attributable to concomitant medication, co-morbid event, or disease progression.
- Percentage of Evaluable Subjects Who Had a Response Greater Than 20 Spot-forming Cells (SFC) Per 10^6 Lymphocytes [ Time Frame: From time of pheresis #1, one day prior to first pre-surgery vaccine dose, until the time of the third post-surgery vaccination, an expected average of 24 weeks after study initiation ]The number of spot-forming cells (SFC) per 10^6 lymphocytes measured by ELISpot. A blue-black colored precipitate forms and appears as spots at the sites of cytokine localization, with each individual spot representing an individual analyte-secreting cell.
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): NCT02193347
|United States, North Carolina|
|Duke University Medical Center|
|Durham, North Carolina, United States, 27710|
|Principal Investigator:||Katherine Peters, M.D., Ph.D.||Duke University|