Status:
COMPLETED
Vaccine Therapy With Sargramostim (GM-CSF) in Treating Patients With Her-2 Positive Stage III-IV Breast Cancer or Ovarian Cancer
Lead Sponsor:
University of Washington
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
HER2-positive Breast Cancer
Stage III Ovarian Epithelial Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE1
Brief Summary
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 o...
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 determi...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2025
Estimated Enrollment :
66 Patients enrolled
Trial Details
Trial ID
NCT00436254
Start Date
October 1 2001
End Date
April 1 2025
Last Update
April 6 2025
Active Locations (1)
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1
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Seattle, Washington, United States, 98109