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HER-2/neu Peptide Vaccine for Ovarian Cancer

Phase 1 & 2
Waitlist Available
Led By Mary Disis
Research Sponsored by University of Washington
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 up to 5 years
Awards & highlights

Study Summary

This trial looks at the side effects of a vaccine made from HER2 peptides in patients with stage IV breast or ovarian cancer. The goal is to see if the vaccine can help increase HER2 specific immunity and immune memory cells.

Eligible Conditions
  • Ovarian Cancer
  • HER2 Positive
  • HLA-A2 Positive Cells
  • Breast Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Immune Response Measured by IFN-gamma Secreting PBMC Precursor Frequency by ELIspot and HLA-A2 Major Histocompatibility Complex Tetramer Analysis
Number of Adverse Events Graded Using National Cancer Institute (NCI) Cancer Therapy Evaluation Program (CTEP) Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0
Secondary outcome measures
Overall Survival

Side effects data

From 2023 Phase 1 & 2 trial • 22 Patients • NCT00194714
95%
Fatigue
95%
Injection Site Reaction
67%
Myalgia
67%
Pain - Headache
57%
Rigors/Chills
57%
Pruritis/Itching
52%
Nausea
48%
Leukopenia
48%
Lymphopenia
48%
Diarrhea
48%
Infection with normal ANC or GRA1 or 2 neutrophils
38%
Anemia
38%
Edema:limb
33%
Neutrophils/granulocytes (ANC/AGC)
33%
Dizziness
29%
Rash/desquamation
29%
Palpatations
29%
Flu-like syndrome
24%
Vomiting
24%
Pain - Arlthralgia
19%
Urticaria (hives, welts, wheals)
19%
Rash/acneiiform
19%
Hypertension
19%
Pain - Abdomen NOS
19%
Pain - Back
19%
Fever
14%
Dyspnea (shortness of breath)
14%
Platelets low
14%
Left ventricular systolic dysfunction
14%
Pain - Injection site
14%
Alopecia
14%
Neuropathy: sensory
10%
Dry skin
10%
Hypokalemia
10%
aspartate aminotransferase (AST)/SGOT
10%
Pain - Lymphnode
10%
Hyponatremia
10%
Nail changes
10%
Alanine aminotransferase increased (ALT)/SGPT
10%
Hyperglycemia
10%
Creatinine
10%
Neuropathy: motor
5%
Pain - Breast
5%
Pain - Lung
5%
Ulceration
5%
Supraventricular and nodal arrhythmia
5%
Bronchospasm, wheezing
5%
Flushing
5%
Eosinophilia
5%
Weepiness
5%
Chest tightness
5%
Pain - Pleuritic
5%
Pain - Leg cramps
5%
Pain - Bone
5%
Leukocytosis
5%
Pain - Chest Wall
5%
Pain - Neck
5%
Pain - Rib
5%
CNS Cerebrovascular Ischema
5%
Bruising
5%
Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip)
5%
Cardiac Arrhythmia
5%
Sweating
5%
Skin breakdown/decubitus ulcer
5%
Hypopigmentation
5%
Hot flashes
5%
Constipation
5%
Mucositis/stomatisis (functional/symptomatic)
5%
Blood in stool
5%
Hemorrhage, GU
5%
Infection without neutrophils
5%
Edema: Head and neck
5%
Swelling left breast
5%
Lymphnode pain
5%
Hypoalbuminemia
5%
Tendonitis
5%
Confusion
5%
Syncope
5%
Hemorrhage/Bleeding associated with surgery, intra-operative or postoperative
5%
Urine leukocytes
5%
Vision - blurred
100%
80%
60%
40%
20%
0%
Study treatment Arm
Treatment (HER-2/Neu Peptide Vaccine)

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (HER-2/neu peptide vaccine)Experimental Treatment2 Interventions
Patients receive HER-2/neu peptide vaccine ID once per month for 6 months in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
HER-2/neu Peptide Vaccine
2016
Completed Phase 2
~30

Find a Location

Who is running the clinical trial?

University of WashingtonLead Sponsor
1,724 Previous Clinical Trials
1,821,365 Total Patients Enrolled
7 Trials studying Ovarian Cancer
505 Patients Enrolled for Ovarian Cancer
National Cancer Institute (NCI)NIH
13,603 Previous Clinical Trials
40,913,253 Total Patients Enrolled
286 Trials studying Ovarian Cancer
73,708 Patients Enrolled for Ovarian Cancer
Mary DisisPrincipal InvestigatorFred Hutch/University of Washington Cancer Consortium
5 Previous Clinical Trials
136 Total Patients Enrolled

Frequently Asked Questions

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

Is enrollment for this experimental study still open?

"Based on the information available, this medical trial is not presently accepting new patients. Initially posted in May 2016 and last updated in late May 2022, it does not appear to be recruiting at this time. However, there are 580 other clinical trials currently searching for participants."

Answered by AI
~2 spots leftby Mar 2025