NCT00436254CompletedPhase 1
Vaccine Therapy With Sargramostim (GM-CSF) in Treating Patients With Her-2 Positive Stage III-IV Breast Cancer or Ovarian Cancer
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
Source: ClinicalTrials.gov · Last updated 6 Apr 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 66 (actual)
- First submitted
- 15 Feb 2007
- Start date
- 1 Oct 2001
- Primary completion date
- 31 Mar 2010
- Lead sponsor
- University of Washington
- Diseases
- Metastatic breast cancer, Ovarian cancer
- NCT number
- NCT00436254
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 66
- From 1 Oct 2001 to the primary completion date, 31 Mar 2010
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- Active autoimmune disease
- Subjects cannot have active immunodeficiency disorder, e.g., HIV
Other
- Subjects cannot be simultaneously enrolled on other treatment studies
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium Coordinator of this site? Confirm its status | Seattle | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.