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Cancer Vaccine
HER2/neu DNA Immunization for Breast Cancer
Phase 1
Waitlist Available
Led By Carlos Dos Anjos, MD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients may be receiving hormonal therapy
Patients may have already received trastuzumab (Herceptin) or be receiving trastuzumab during this study
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at week 19 or at the discretion of the physician
Awards & highlights
Study Summary
This trial will evaluate whether the injection of HER2/neu DNA is safe and stimulates an immune response in patients with breast cancer.
Who is the study for?
This trial is for adults over 18 with Stage III or metastatic breast cancer that has high levels of HER2. Participants must have finished previous treatments at least 4 weeks prior, can be on hormone therapy/trastuzumab, and should not have severe organ dysfunction or other active cancers. Pregnant women and those with certain heart conditions are excluded.Check my eligibility
What is being tested?
The study tests the safety and immune response to an injected DNA vaccine containing a gene for rat HER2 protein. It aims to immunize patients against their own tumor cells by stimulating antibody and T-cell production in individuals with high HER2 expression tumors.See study design
What are the potential side effects?
Potential side effects may include typical vaccine reactions such as pain at the injection site, fever, fatigue, allergic responses, or autoimmune-like symptoms due to immune system activation against body tissues.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am currently on hormonal therapy.
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I am currently taking or have taken Herceptin for my cancer.
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I haven't had major surgery or chemotherapy for 4 weeks, but I may be on hormonal therapy or trastuzumab.
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My cancer can be measured, seen but not measured, or currently shows no signs.
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I am older than 18 years.
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I can carry out normal activities with minimal symptoms.
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My cancer is HER2 positive based on specific tests.
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My breast cancer is advanced (Stage III or IV) and HER2 positive.
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I have stage IV breast cancer but currently show no signs of it getting worse.
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My breast cancer was stage III and I finished my treatment less than 3 years ago.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at week 19 or at the discretion of the physician
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at week 19 or at the discretion of the physician
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
The maximum tolerated dose over four dose levels
Secondary outcome measures
A secondary endpoint is to observe patients for any evidence of anti-tumor effect.
Side effects data
From 2014 Phase 4 trial • 32 Patients • NCT0130172959%
Leukopenia
56%
Neutropenia
34%
Hypoaesthesia
31%
Agranulocytosis
22%
Alopecia
22%
Asthenia
19%
Pyrexia
16%
Nail disorder
16%
Oedema peripheral
16%
Diarrhoea
16%
Hypophagia
13%
Neurotoxicity
13%
Alanine aminotransferase increased
13%
Cough
13%
Vomting
9%
Headache
9%
Musculoskeletal pain
9%
Aspartate aminotransferase increased
9%
Chest discomfort
9%
Rash
9%
Pigmentation disorder
9%
Nausea
9%
Bone marrow failure
9%
Anaemia
6%
Transaminases increased
6%
Insomnia
6%
Constipation
6%
Mouth ulceration
6%
Nasopharyngitis
6%
Paronychia
6%
Flushing
6%
Face oedema
6%
Thrombocytopenia
3%
Infection
3%
Upper respiratory tract infection
3%
Completed suicide
3%
Cataract
100%
80%
60%
40%
20%
0%
Study treatment Arm
Trastuzumab
Trial Design
1Treatment groups
Experimental Treatment
Group I: 1Experimental Treatment1 Intervention
HER2 ECD DNA.
Find a Location
Who is running the clinical trial?
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,933 Previous Clinical Trials
585,607 Total Patients Enrolled
202 Trials studying Breast Cancer
81,124 Patients Enrolled for Breast Cancer
Carlos Dos Anjos, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
Jedd Wolchok, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
2 Previous Clinical Trials
30 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- It is expected that you may not live for more than 6 months.I have a history of heart disease, including heart attack, heart failure, or other heart conditions.You have a history of a weakened immune system or a condition where your immune system attacks your body.I am currently on antibiotics for an infection.I have not had any active cancers in the last 5 years, except for non-melanoma skin cancer.I have a tumor in my brain or spinal cord.I have received more than 600 mg/m2 of epirubicin.I am currently on hormonal therapy.I am currently taking or have taken Herceptin for my cancer.I haven't had major surgery or chemotherapy for 4 weeks, but I may be on hormonal therapy or trastuzumab.My blood tests show low white cells or platelets, or high kidney or liver markers.I have received more than 360 mg/m2 of doxorubicin.You are currently breastfeeding.My cancer can be measured, seen but not measured, or currently shows no signs.I am older than 18 years.I have received a breast cancer vaccine in the past.I can carry out normal activities with minimal symptoms.I am not on any medication that could interfere with treatment or vaccines.My cancer is HER2 positive based on specific tests.My breast cancer is advanced (Stage III or IV) and HER2 positive.I have stage IV breast cancer but currently show no signs of it getting worse.My breast cancer was stage III and I finished my treatment less than 3 years ago.
Research Study Groups:
This trial has the following groups:- Group 1: 1
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the aggregate number of participants for this experiment?
"Unfortunately, this medical study is no longer open for enrolment. It was first posted on the 1st of May 2006 and last updated on the 7th of October 2022. For those seeking alternative clinical studies to participate in, there are currently 2600 trials recruiting patients with breast cancer and 191 trails searching for people who might benefit from MAB HER 2 (HERCEPTIN) treatments."
Answered by AI
What conditions is MAB HER 2 (HERCEPTIN) typically prescribed for?
"MAB HER 2 (HERCEPTIN) is a widely used intervention for breast cancer. Additionally, it may be beneficial in treating other illnesses such as reduced risk of recurrence and post-operative complications."
Answered by AI
Has the Food and Drug Administration granted clearance to utilize MAB HER 2 (HERCEPTIN)?
"Due to the limited amount of evidence available on its efficacy and safety, MAB HER 2 (HERCEPTIN) was rated as a 1 with our team at Power."
Answered by AI
Are there still opportunities to partake in this medical experiment?
"According to records from clinicaltrials.gov, this trial is not currently welcoming patients; however it was published on May 1st 2006 and updated on October 7th 2022. In the present moment, there are 2,791 other studies actively recruiting participants across the globe."
Answered by AI
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