A Phase I Cancer Vaccine Study for Patients With Metastatic Breast Cancer
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ClinicalTrials.gov Identifier: NCT00715832 |
Recruitment Status : Unknown
Verified August 2009 by Southern Cancer Center.
Recruitment status was: Recruiting
First Posted : July 15, 2008
Last Update Posted : August 26, 2009
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Metastatic Breast Cancer | Biological: Dendritic Cell Vaccination | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 25 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase I Vaccine Study With Autologous Dendritic Cells Loaded With Oncofetal Antigen/iLRP in Patients With Metastatic Breast Cancer |
Study Start Date : | May 2008 |
Estimated Primary Completion Date : | February 2010 |
Estimated Study Completion Date : | February 2015 |

- Biological: Dendritic Cell Vaccination
Autologous dendritic dells will be pulsed with human recombinant oncofetal antigen (OFP/iLRP). The vaccine will be injected intradermally
- toxicity [ Time Frame: 24 months ]
- Response, Survival, Immunological Monitoring, Time to Disease Progression [ Time Frame: 24 months ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 85 Years (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Stage IV histologically proven breast cancer as defined by the AJCC Cancer Staging Manual (6 th. Edition 2003).
- Patients must have completed one prior form of chemo and/or radiation therapy for their disease and have failed to achieve remission.
- There must be no clinical or radiographic signs of active brain metastases (CT of brain), or disease to the brain that is not considered controlled.
- At least 4 weeks must have elapsed since chemotherapy or biological therapy and 2 weeks must have elapsed since radiotherapy
- Female patients must be at least 18 years of age
- Must be ambulatory with a ECOG performance status of <2
- Must have common recall antigen DTH skin reaction >2 mm
- Must have lab values as following ANC > 1.5 x 109/L; platelets > 100 x 109/L, Hb> 9 g/dL, creatinine < 1.8 mg/dL or a creatinine clearance > 35 mL/min; total bilirubin < 2 the upper limit of normal, AST and ALT < 2.5 the upper limit of normal; albumin >2.5 g/L
- If of child bearing potential, must practice a reliable method of contraception at screening and must agree to continue this status until 6 months after receiving the last study vaccine injection. An HCG (pregnancy) test will be done monthly until the 3 vaccinations are complete.
- Signed informed consent (see Appendix A, Clinical Protocol section 25.1) to be obtained according to ICH GCP guidelines before the patient is subjected to any extra diagnostic procedures performed for evaluation of eligibility for the trial.
Exclusion Criteria:
- History of other prior malignancy, with the exception of curatively treated basal cell or squamous cell carcinoma of the skin or cervical cancer stage IB
- Active infection requiring continuous use of antibiotic therapy
- Significant cardiac or other medical illness that would limit activity or survival, such as severe congestive heart failure, unstable angina, or serious cardiac arrhythmia
- Autoimmune disease currently treated with steroids
- Adverse reactions to vaccines such as anaphylaxis or other serious reactions, e.g. life-threatening reactions to medicine
- History of immunodeficiency or autoimmune disease such as rheumatoid arthritis,systemic lupus erythematosus, scleroderma, polymyositis dermatomyositis, juvenile onset, insulin dependent diabetes, or a vasculitic syndrome
- Pregnancy or lactation
- Any reason why, in the opinion of the investigator, the patient should not participate
- Patients who have received cytotoxic anti-tumor therapy within 4 weeks prior to vaccination
- Patients with active hepatitis (B, C) or HIV+ individuals
- Patients with more than four different lines of chemotherapy in the metastatic setting (excluding adjuvant chemotherapy).

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00715832
Contact: Kelli Wilson | 251 442 9452 | kelliwilson@quantumimmunologics.com | |
Contact: Sheri Murray, RN, BSN | 251/259-5587 | sherimurray@quantumimmunologics.com |
United States, Alabama | |
Quantum Immunologics | Recruiting |
Mobile, Alabama, United States, 36606 | |
Contact: Kelli Wilson 251-442-9452 kelliwilson@quantumimmunologics.com | |
Principal Investigator: Paul Schwarzenberger, MD | |
Sub-Investigator: Joseph Coggin, PhD |
Responsible Party: | Paul Schwarzenberger, MD, Quantum Immunologics http://quantumimmunologics.com |
ClinicalTrials.gov Identifier: | NCT00715832 |
Other Study ID Numbers: |
QI-Breast Vaccine 1 |
First Posted: | July 15, 2008 Key Record Dates |
Last Update Posted: | August 26, 2009 |
Last Verified: | August 2009 |
Breast cancer Dendritic cell vaccine OFA/iLRP Patients |
Line Chemotherapy Setting Four different lines |
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases |
Skin Diseases Vaccines Immunologic Factors Physiological Effects of Drugs |