Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsors and Collaborators: |
University of Washington National Cancer Institute (NCI) |
---|---|
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00436254 |
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 GM-CSF may be an effective treatment for breast cancer or ovarian cancer.
PURPOSE: This phase I trial is studying the side effects and best dose of vaccine therapy when given together with GM-CSF in treating patients with stage III or stage IV breast cancer or stage III or stage IV ovarian cancer.
Condition | Intervention | Phase |
---|---|---|
Breast Cancer Ovarian Cancer |
Drug: pNGVL3-hICD vaccine Drug: sargramostim Procedure: adjuvant therapy Procedure: biopsy Procedure: flow cytometry Procedure: immunoenzyme technique Procedure: immunologic technique Procedure: protein expression analysis |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | 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 |
Estimated Enrollment: | 66 |
Study Start Date: | October 2001 |
Estimated Primary Completion Date: | February 2008 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a dose-escalation study of pNGVL3-hICD vaccine.
Patients receive pNGVL3-hICD vaccine and sargramostim (GM-CSF) intradermally once a month for 3 months in the absence of disease progression or unacceptable toxicity.
Cohorts of up to 22 patients receive escalating doses of pNGVL3-hICD vaccine until ≥ 1 patient experiences dose-limiting toxicity.
Patients undergo leukapheresis over 3-5 hours at 3 months after the last vaccination to obtain peripheral blood mononuclear cells for T-cell immunity studies. Patients also undergo skin biopsies at 1 and 6 months after the last vaccination to evaluate continued antigen expression.
Blood samples are obtained at baseline and then periodically during and after study treatment. Samples are examined for immune response by immunological laboratory methods. Flow cytometry and immunoenzyme techniques are also performed on samples.
After completion of study treatment, patients are followed periodically for up to 15 years.
PROJECTED ACCRUAL: A total of 66 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed diagnosis of 1 of the following:
Breast cancer, meeting 1 of the following stage criteria:
Stage IV disease, meeting all of the following criteria:
Ovarian cancer, meeting 1 of the following stage criteria:
Stage IV disease, meeting both of the following criteria:
HER2-overexpressing disease
PATIENT CHARACTERISTICS:
No known history of cardiac disease
Female patients must be unable to bear children as a result of 1 of the following:
PRIOR CONCURRENT THERAPY:
United States, Washington | |
University of Washington School of Medicine | Recruiting |
Seattle, Washington, United States, 98195 | |
Contact: Clinical Trials Office - University of Washington School of Me 206-616-8289 |
Principal Investigator: | Mary (Nora) L. Disis, MD | University of Washington |
Study ID Numbers: | CDR0000528923, UWASH-01-9773-D07 |
Study First Received: | February 15, 2007 |
Last Updated: | January 13, 2009 |
ClinicalTrials.gov Identifier: | NCT00436254 |
Health Authority: | Unspecified |
stage IIIA breast cancer stage IIIB breast cancer stage IIIC breast cancer stage IV breast cancer stage III ovarian epithelial cancer |
stage III ovarian germ cell tumor stage IV ovarian epithelial cancer stage IV ovarian germ cell tumor ovarian sarcoma ovarian stromal cancer |
Ovarian cancer Ovarian Neoplasms Skin Diseases Gonadal Disorders Malignant mesenchymal tumor Genital Neoplasms, Female Breast Neoplasms Endocrine System Diseases Urogenital Neoplasms |
Ovarian Diseases Ovarian epithelial cancer Soft tissue sarcomas Genital Diseases, Female Sarcoma Endocrinopathy Breast Diseases Endocrine Gland Neoplasms |
Neoplasms Neoplasms by Site Adnexal Diseases |