Description:
The purpose of the study is to treat patients with Ductal carcinoma in situ (DCIS) with a
combined treatment of DC1 vaccine with Trastuzumab. In this study the investigators will
assess the safety and immunogenicity of the combination therapy. The target population is
women over 18 years of age and have a diagnosis of DCIS that express HER-2 3 positive.
Participants will receive 6 vaccines along with 2 doses of trastuzumab.
This study began at the Abramson Cancer Center of the University of Pennsylvania and will
continue at H. Lee Moffitt Cancer Center and Research Institute.
Title
- Brief Title: A Phase I/II Trial of HER-2/Neu Pulsed DC1 Vaccine Combined With Trastuzumab for Patients With DCIS
- Official Title: A Phase I/II Trial of HER-2/Neu Pulsed DC1 Vaccine Combined With Trastuzumab for Patients With DCIS
Clinical Trial IDs
- ORG STUDY ID:
UPCC 03114
- NCT ID:
NCT02336984
Conditions
Interventions
Drug | Synonyms | Arms |
---|
HER-2 pulsed DC1 | vaccine | Combination Therapy |
trastuzumab | Herceptin | Combination Therapy |
pertuzumab | Perjeta | Combination Therapy |
Purpose
The purpose of the study is to treat patients with Ductal carcinoma in situ (DCIS) with a
combined treatment of DC1 vaccine with Trastuzumab. In this study the investigators will
assess the safety and immunogenicity of the combination therapy. The target population is
women over 18 years of age and have a diagnosis of DCIS that express HER-2 3 positive.
Participants will receive 6 vaccines along with 2 doses of trastuzumab.
This study began at the Abramson Cancer Center of the University of Pennsylvania and will
continue at H. Lee Moffitt Cancer Center and Research Institute.
Trial Arms
Name | Type | Description | Interventions |
---|
Combination Therapy | Experimental | Combination Therapy: HER-2 pulsed DC1 vaccine with trastuzumab and pertuzumab. | - HER-2 pulsed DC1
- trastuzumab
- pertuzumab
|
Eligibility Criteria
Inclusion Criteria:
- Women >= 18 years.
- Ductal carcinoma in situ (DCIS) that express HER-2 3+ on 10% of the DCIS that have not
had definitive surgery are diagnosed by core biopsy or NL surgical biopsy with
positive margins.
- Patients that are ER+ will take anti-estrogen therapy for treatment of their DCIS
during vaccinations.
- Women of childbearing age with a negative pregnancy test documented prior to
enrollment.
- Eastern Cooperative Oncology Group (ECOG) Performance Status Score of 0 or 1.
- Women of childbearing potential must agree to use a medically acceptable form of birth
control during their participation in the study.
- Have voluntarily signed a written Informed Consent in accordance with institutional
policies after its contents have been fully explained to them.
Exclusion Criteria
- Pregnant or lactating.
- Positive for HIV or hepatitis C at baseline by self-report.
- Potential participants with coagulopathies, including thrombocytopenia with platelet
count <75,000, INR> 1.5 and partial thromboplastin time > 50 sec
- Major cardiac illness MUGA or ECHO <50% EF.
- Pre-existing medical illnesses or medications which might interfere with the study as
determined by Principal Investigator (PI).
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | Female |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Occurrence of Related Adverse Events (AEs) |
Time Frame: | 5 years |
Safety Issue: | |
Description: | Occurrence of AEs related to study treatment. Adverse Events will be graded according to NCI Common Toxicity Criteria for Adverse Events (CTCAE) V 4.02. |
Details
Phase: | Phase 1/Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Withdrawn |
Lead Sponsor: | H. Lee Moffitt Cancer Center and Research Institute |
Trial Keywords
- Ductal carcinoma in situ (DCIS)
Last Updated
January 11, 2021