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| Sponsor: | Sidney Kimmel Comprehensive Cancer Center |
|---|---|
| Collaborators: |
American Cancer Society Avon Foundation Cancer Treatment Research Foundation Commonwealth Foundation Department of Defense Genentech |
| Information provided by: | Sidney Kimmel Comprehensive Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00399529 |
Purpose
This is a feasibility study to examine combination therapy with Trastuzumab (T), Cyclophosphamide (CY), and an allogeneic GM-CSF-secreting whole cell breast cancer vaccine in patients with Stage IV HER-2/neu-overexpressing breast cancer. The main purposes of this study are to test the safety, clinical benefit, and bioactivity of vaccine therapy in combination with Cyclophosphamide and Trastuzumab in patients with HER-2/neu-overexpressing Stage IV breast cancer. This study will also to test whether the Cyclophosphamide can eliminate the suppressive influence of regulatory T cells, and whether Trastuzumab can increase antigen processing and presentation. These drug activities may make the immune system react better and enhance the effects of the vaccine in treating breast cancer. The vaccine consists of two irradiated allogeneic mammary carcinoma cell lines genetically modified to secrete human granulocyte-macrophage colony stimulating factor (GM-CSF). This open label, single arm study is designed to recruit up to 40 subjects to identify 20 research subjects with HER-2/neu-overexpressing Stage IV breast cancer eligible for study treatment.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Neoplasms |
Biological: Allogeneic GM-CSF-secreting breast cancer vaccine Drug: Trastuzumab Drug: Cyclophosphamide |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | A Feasibility Study of Combination Therapy With Trastuzumab, Cyclophosphamide, and an Allogeneic GM-CSF-secreting Breast Tumor Vaccine for HER-2/Neu-Overexpressing Metastatic Breast Cancer. |
| Estimated Enrollment: | 20 |
| Study Start Date: | September 2006 |
| Estimated Study Completion Date: | April 2013 |
| Estimated Primary Completion Date: | August 2010 (Final data collection date for primary outcome measure) |
Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Maryland | |
| The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | |
| Baltimore, Maryland, United States, 21231 | |
| Principal Investigator: | Leisha A Emens, M.D.,Ph.D. | Johns Hopkins University |
More Information
| Responsible Party: | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins ( Leisha A. Emens, MD, PhD ) |
| Study ID Numbers: | J05118, JHMIRB RPN001801, RAC 0605-778 |
| Study First Received: | November 13, 2006 |
| Last Updated: | August 31, 2009 |
| ClinicalTrials.gov Identifier: | NCT00399529 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Stage IV HER-2/neu overexpressing breast cancer |
|
Molecular Mechanisms of Pharmacological Action Skin Diseases Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Breast Neoplasms Cyclophosphamide Immunosuppressive Agents Pharmacologic Actions |
Neoplasms Neoplasms by Site Therapeutic Uses Myeloablative Agonists Trastuzumab Antineoplastic Agents, Alkylating Antirheumatic Agents Alkylating Agents Breast Diseases |