Cellular Immunotherapy Study With Autologous Dendritic Cells Loaded With Oncofetal Antigen/iLRP in Patients With Metastatic Breast Cancer
Recruitment status was Active, not recruiting
Tracking Information | |||||
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First Received Date ICMJE | April 9, 2009 | ||||
Last Updated Date | February 23, 2011 | ||||
Start Date ICMJE | May 2008 | ||||
Estimated Primary Completion Date | March 2011 (final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Toxicity [ Time Frame: 24 months ] [ Designated as safety issue: No ] | ||||
Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | Complete list of historical versions of study NCT00879489 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures ICMJE |
Response, Survival, Immunological Monitoring, Time to Disease Progression [ Time Frame: 24 months ] [ Designated as safety issue: No ] | ||||
Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Outcome Measures ICMJE | |||||
Original Other Outcome Measures ICMJE | |||||
Descriptive Information | |||||
Brief Title ICMJE | Cellular Immunotherapy Study With Autologous Dendritic Cells Loaded With Oncofetal Antigen/iLRP in Patients With Metastatic Breast Cancer | ||||
Official Title ICMJE | Phase I/II Cellular Immunotherapy Study With Autologous Dendritic Cells Loaded With Oncofetal Antigen/iLRP in Patients With Metastatic Breast Cancer | ||||
Brief Summary | The study uses a molecule or particle that is found only on cancer cells and is unique to cancer cells, as it is not detected on normal tissue. The molecule is known as "oncofetal antigen" or OFA. Because OFA is unique to cancer, the investigators feel OFA could be used to educate the patients' own defenses to more effectively fight the cancer on his or her own, that he or she is harboring. Although investigators found OFA to be present in large concentrations on all cancers, it was found to be especially abundant in breast cancers. Therefore, the investigators feel that this molecule would be a good target for stimulating patient defenses especially against breast cancer cells. To accomplish this, certain defense cells (immune cells)will be washed out from the patients' blood using a machine to which the patient is connected through two small cannula placed into veins located in the patients' arms those cells will be manipulated in the laboratory with artificially engineered OFA. These "reeducated" cells will be injected into the skin of patients. There will be a series of three skin injections in 4 week intervals. It is hoped that this treatment will convert the patients' defenses to a point that effective anti-cancer responses will be induced. Effectiveness of the treatment will be monitored with blood tests and assessment of the size of the cancers. |
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Detailed Description | |||||
Study Type ICMJE | Interventional | ||||
Study Phase | Phase 1 Phase 2 |
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Study Design ICMJE | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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Condition ICMJE | Breast Cancer | ||||
Intervention ICMJE | Biological: Dendritic Cell Vaccination
Autologous dendritic cells will be pulsed with human recombinant oncofetal antigen (OFP/iLRP). The vaccine will be injected intradermally. |
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Study Arm (s) | |||||
Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Active, not recruiting | ||||
Estimated Enrollment ICMJE | 24 | ||||
Estimated Completion Date | September 2011 | ||||
Estimated Primary Completion Date | March 2011 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Female | ||||
Ages | 18 Years to 85 Years | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Location Countries ICMJE | United States | ||||
Administrative Information | |||||
NCT Number ICMJE | NCT00879489 | ||||
Other Study ID Numbers ICMJE | NCT00715832 | ||||
Has Data Monitoring Committee | No | ||||
Responsible Party | Charles Broes, CEO, Quantum Immunologics, Inc. | ||||
Study Sponsor ICMJE | Quantum Immunologics, Inc. | ||||
Collaborators ICMJE | University of South Alabama | ||||
Investigators ICMJE |
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Information Provided By | Quantum Immunologics, Inc. | ||||
Verification Date | April 2009 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |