- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00436254
Vaccine Therapy With Sargramostim (GM-CSF) in Treating Patients With Her-2 Positive Stage III-IV Breast Cancer or Ovarian Cancer
October 20, 2023 updated by: University of Washington
A Phase I Study of a DNA Plasmid Based Vaccine Encoding the HER-2/Neu Intracellular Domain in Subjects With HER-2/Neu (HER2) Overexpressing Tumors
RATIONALE: Vaccines may help the body build an effective immune response to kill tumor cells.
Colony-stimulating factors, such as GM-CSF, may increase the number of immune cells found in bone marrow or peripheral blood.
Giving vaccine therapy together with sargramostim may be an effective treatment for breast cancer and ovarian cancer.
PURPOSE: This phase I trial is studying the side effects and identifying the best dose of vaccine therapy when given together with sargramostim in treating patients with stage III-IV breast cancer or ovarian cancer.
Study Overview
Status
Active, not recruiting
Conditions
Detailed Description
PRIMARY OBJECTIVES: I. To determine the safety of intradermal administration of 3 doses of a plasmid-based DNA vaccine encoding the ICD of HER2 administered with a fixed dose of GM-CSF.
II.
To determine whether a plasmid DNA vaccine encoding the ICD of HER2 can elicit HER2 specific immune responses.
SECONDARY OBJECTIVES: I. To determine if the dose of the plasmid-based DNA vaccine effects immunologic responses.
II.
To determine the persistence of DNA at the site of vaccination.
OUTLINE: This is a dose-escalation study of a plasmid-based DNA (pNGVL3-hICD) vaccine.
Patients receive pNGVL3-hICD vaccine admixed with GM-CSF intradermally once a month for 3 months in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up periodically for up to 15 years with primary physicians.
Study Type
Interventional
Enrollment (Actual)
66
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Washington
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Seattle, Washington, United States, 98109
- Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Breast cancer: stage III or stage IV breast cancer with metastasis in remission and defined as NED (no evidence of disease); stable or healing bone disease by radiologic evaluation which may include, but is not limited to, bone scan, MRI, or PET scan documented within 90 days of enrollment to study and NED status for extraskeletal metastasis
- Ovarian cancer: stage III or stage IV ovarian cancer in first complete remission with a normal AND stable CA-125; thus, two sequential normal CA-125 values will need to be documented; a minimum of 30 days between 2 sequential CA-125 values; the most recent will be within 2 weeks of enrollment into study
- HER2 overexpression by immunohistochemistry (IHC) of 2+ or 3+ in their primary tumor or metastasis, and if overexpression is 2+ by IHC or in the absence of IHC, then patients must have documentation of HER2 gene amplification by FISH
- Eligible subjects must have completed appropriate treatment for their primary disease and be off cytotoxic chemotherapy and corticosteroids for at least 1 month prior to enrollment; patients with stage III/IV breast cancer who have completed chemotherapy and are continued on trastuzumab monotherapy are eligible; hormonal and bisphosphanate therapies are allowed
- Subjects must have a Performance Status Score (Zubrod/ECOG Scale) = 0
- All subjects must no longer be able to bear children
- Hematocrit >= 30
- Platelet count >= 100,000
- WBC >= 3,000/ul
- Creatinine =< 2.0 or creatinine clearance >= 60 ml/minute
- Serum bilirubin < 1.5 mg/dl
- SGOT < 2 x ULN
- Subjects must have recovered from major infections and/or surgical procedures and, in the opinion of the investigator, not have a significant active concurrent medical illness precluding protocol treatment or survival
- Normal ANA, anti-dsDNA and C3
- Patients on trastuzumab monotherapy must have adequate cardiac function as demonstrated by normal ejection fraction (EF) of MUGA scan or echocardiogram
Exclusion Criteria:
- Subjects cannot be simultaneously enrolled on other treatment studies
- Any contraindication to receiving GM-CSF based vaccine products
- Prior known history of cardiac disease, specifically restrictive cardiomyopathy, unstable angina within the last 6 months prior to enrollment, New York Heart Association functional class III-IV heart or symptomatic pericardial effusion
- Prior known history of pulmonary disease other than controlled asthma
- Active autoimmune disease
- Subjects cannot have active immunodeficiency disorder, e.g., HIV
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Arm I
Patients receive pNGVL3-hICD vaccine admixed with GM-CSF intradermally once a month for 3 months in the absence of disease progression or unacceptable toxicity.
|
Correlative studies
Correlative studies
Other Names:
Plasmid-based DNA vaccine, given intradermally
Given intradermally
Other Names:
Undergo ELIspot (correlative studies)
Other Names:
Undergo ELISA (correlative studies)
Undergo punch biopsy (correlative studies)
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Safety as measured by NCI CTCAE v 3.0
Time Frame: From baseline
|
From baseline
|
Immune response
Time Frame: From baseline
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From baseline
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Impact of dose on immunologic response
Time Frame: From baseline to month 15
|
From baseline to month 15
|
Persistence of DNA at the injection site
Time Frame: At 1 and 6 months after last vaccination
|
At 1 and 6 months after last vaccination
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Mary L. Disis, Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2001
Primary Completion (Actual)
March 1, 2010
Study Completion (Estimated)
December 1, 2024
Study Registration Dates
First Submitted
February 15, 2007
First Submitted That Met QC Criteria
February 15, 2007
First Posted (Estimated)
February 19, 2007
Study Record Updates
Last Update Posted (Actual)
October 24, 2023
Last Update Submitted That Met QC Criteria
October 20, 2023
Last Verified
October 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Skin Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Genital Neoplasms, Female
- Endocrine System Diseases
- Ovarian Diseases
- Adnexal Diseases
- Gonadal Disorders
- Endocrine Gland Neoplasms
- Breast Diseases
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urogenital Diseases
- Genital Diseases
- Genital Diseases, Female
- Neoplasms, Germ Cell and Embryonal
- Breast Neoplasms
- Ovarian Neoplasms
- Carcinoma, Ovarian Epithelial
- Germinoma
- Physiological Effects of Drugs
- Antineoplastic Agents
- Immunologic Factors
- Sargramostim
- Molgramostim
Other Study ID Numbers
- 6532
- NCI-2010-00869
- RG1704001 (Other Identifier: Fred Hutch/University of Washington Cancer Consortium)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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