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Cancer Vaccine

PEPIDH1M vaccine for Brain Metastases (RESIST Trial)

Phase 1
Waitlist Available
Led By Katherine Peters, M.D., Ph.D.
Research Sponsored by Katy Peters, MD, PhD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up date of consent through 2 months after the last vaccination
Awards & highlights

RESIST Trial Summary

This trial is testing a vaccine for a type of brain tumor. The vaccine will be given with standard chemotherapy to see if it is safe.

Eligible Conditions
  • Brain Metastases
  • Brain Tumor
  • Brain Cancer

RESIST Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~date of consent through 2 months after the last vaccination
This trial's timeline: 3 weeks for screening, Varies for treatment, and date of consent through 2 months after the last vaccination for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percentage of Participants With an Unacceptable Toxicity
Secondary outcome measures
Percentage of Patients With a Positive Vaccine Response After 3 Post-Surgery Vaccines as Measured by IFNγ ELIspot

Side effects data

From 2020 Phase 1 trial • 24 Patients • NCT02193347
100%
Injection site reaction
100%
Hypertension
83%
Anemia
79%
Hyperglycemia
71%
Skin induration
54%
Fatigue
50%
Hypocalcemia
46%
Constipation
42%
Headache
42%
Nausea
38%
Alanine aminotransferase increased
38%
Aspartate aminotransferase increased
33%
Dysphasia
33%
Seizure
29%
Hyponatremia
29%
White blood cell decreased
29%
Dizziness
29%
Paresthesia
25%
Upper respiratory infection
25%
Platelet count decreased
25%
Hypoalbuminemia
25%
Hypoglycemia
21%
Memory impairment
21%
Pain
21%
Lymphocyte count decreased
21%
Neutrophil count decreased
21%
Pruritus
17%
Insomnia
17%
Depression
17%
Vomiting
17%
Creatinine increased
17%
Anorexia
17%
Hypokalemia
17%
Rash maculo-papular
13%
Back pain
13%
Muscle weakness right-sided
13%
Arthralgia
13%
Anxiety
13%
Diarrhea
13%
Flu like symptoms
13%
Alkaline phosphatase increased
13%
Blurred vision
13%
Blood bilirubin increased
13%
Hypomagnesemia
13%
Cough
13%
Nasal congestion
8%
Pyramidal tract syndrome
8%
Hypophosphatemia
8%
Dyspepsia
8%
Papulopustular rash
8%
Sinusitis
8%
Urinary tract infection
8%
Dry eye
8%
Dehydration
8%
Concentration impairment
8%
Allergic rhinitis
8%
Dyspnea
8%
Dry skin
4%
Peripheral sensory neuropathy
4%
Other, Specify: "PASSING AIR WHEN URINATING"
4%
Other, Specify: LUMP IN LEFT BREAST
4%
Facial nerve disorder
4%
Other, Specify: L SIDED NEGLECT
4%
Muscle weakness left-sided
4%
Hallucinations
4%
Other, Specify: NIGHTMARES
4%
Dysgeusia
4%
Movements involuntary
4%
Hematuria
4%
Urinary retention
4%
Confusion
4%
Other, Specify: INTRACRANIAL ANEURYSM, NONRUPTURED
4%
Tremor
4%
Other, Specify: L HEMIPARESIS
4%
Other, Specify: FOREHEAD NUMBNESS. POST INJECTION #1.
4%
Restlessness
4%
Other, Specify: AURA
4%
Muscle weakness upper limb
4%
Urinary frequency
4%
Urinary urgency
4%
Other, Specify: PSEUDOMENINGOCELE
4%
Other, Specify: DECREASED CIRCULATION IN FEET; BILATERAL
4%
Eye pain
4%
Allergic reaction
4%
Other, Specify: INTERMITTENT; OBJECTS APPEAR TO MOVE OR SHAKE WHEN HOLDING
4%
Infusion related reaction
4%
Other, Specify: HEAD INCISION WITH DRAINAGE AND TENDERNESS; 2+ SERRATIA MARCESCENS
4%
Other, Specify: L EYELID EDEMA
4%
Other, Specify: SEEING A "BROWNISH TINTED VERTICAL STRIPE" FROM RIGHT EYE
4%
Other, Specify: TUNNEL VISION
4%
Abdominal pain
4%
Chills
4%
Fever
4%
Gait disturbance
4%
Bronchial infection
4%
Other, Specify: CELLULITIS
4%
Other, Specify: COLD SORES
4%
Other, Specify: WOUND INFECTION
4%
Mucosal infection
4%
Wound infection
4%
Bruising
4%
Fall
4%
Other, Specify: LEFT WRIST WOUND
4%
Other, Specify: LOWER BACK INJURY
4%
Other, Specify: MVA
4%
Gastroesophageal reflux disease
4%
Edema face
4%
Sinus tachycardia
4%
Other, Specify: INCISION, ABNORMAL TISSUE CULTURE
4%
Other, Specify: SHINGLES
4%
Floaters
4%
Other, Specify: SKIN SLOUGHING
4%
Thromboembolic event
4%
Ventricular arrhythmia
4%
Respiratory failure
4%
Other, Specify: "INNER EAR PRESSURE"
4%
Other, Specify: BLOOD TINGED DRAINAGE
4%
Other, Specify: CLICKING SOUND IN LEFT EAR
4%
Other, Specify: HEARS CLINKING SOUND IN HEAD INTERMITTENTLY
4%
Other, Specify: INTERMITTENT PAIN, TWITCHING, AND/OR NUMBNESS UNDER RIGHT EYE
4%
Hyperkalemia
4%
Myalgia
4%
Other, Specify: BUMPS ON R FOREARM
4%
Other, Specify: L WRIST BUMP/NODULE
4%
Testicular pain
4%
Other, Specify: CONGESTION
4%
Wheezing
4%
Alopecia
4%
Rash acneiform
4%
Scalp pain
4%
Other, Specify: FLUID FILLED POCKET ON R FOREHEAD FROM SURGERY
4%
Other, Specify: FLUID POCKET
4%
Other, Specify: RASH
4%
Other, Specify: RIGHT LOWER EXTREMITY. SKIN DISCOLORATION.
4%
Other, Specify: SKIN BUMP
100%
80%
60%
40%
20%
0%
Study treatment Arm
PEPIDH1M Vaccine

RESIST Trial Design

1Treatment groups
Experimental Treatment
Group I: PEPIDH1M vaccineExperimental Treatment3 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
PEPIDH1M vaccine
2016
Completed Phase 1
~30
Clostridium tetani toxoid antigen (formaldehyde inactivated)
FDA approved
Temozolomide
FDA approved

Find a Location

Who is running the clinical trial?

Katy Peters, MD, PhDLead Sponsor
1 Previous Clinical Trials
48 Total Patients Enrolled
Gary Archer Ph.D.Lead Sponsor
11 Previous Clinical Trials
268 Total Patients Enrolled
Katherine Peters, M.D., Ph.D.Principal InvestigatorDuke University

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who else is applying?

What state do they live in?
New Jersey
How old are they?
18 - 65
What site did they apply to?
Duke University Medical Center
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
IDH1 Peptide Vaccine for Recurrent Grade II Glioma
Katy Peters, MD, PhD 2016. "IDH1 Peptide Vaccine for Recurrent Grade II Glioma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02193347.
~3 spots leftby Apr 2025
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