Cellular Immunotherapy Study With Autologous Dendritic Cells Loaded With Oncofetal Antigen/iLRP in Patients With Metastatic Breast Cancer
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ClinicalTrials.gov Identifier: NCT00879489 |
Recruitment Status : Unknown
Verified April 2009 by Quantum Immunologics, Inc..
Recruitment status was: Active, not recruiting
First Posted : April 10, 2009
Last Update Posted : February 25, 2011
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Breast Cancer | Biological: Dendritic Cell Vaccination | Phase 1 Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 24 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Phase I/II Cellular Immunotherapy 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 : | March 2011 |
Estimated Study Completion Date : | September 2011 |

- Biological: Dendritic Cell Vaccination
Autologous dendritic cells 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 (6th 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 therapy.
- 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 >2mm
- Must have lab values as following ANC >1.5 x 109/L; platelets >100x109/L; Hb>9g/dL; creatinine<1.8 mg/dL or a creatinine clearance > 35 mL/min; total bilirubin < 2 x the upper limit of normal; AST and ALT < 2.5 x 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 prior malignancy, with the exception of curatively treated basal cell or squamous cell carcinoma of the skin or cervical cancer stage 1B
- 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): NCT00879489
United States, Alabama | |
Quantum Immunologics, Inc. | |
Mobile, Alabama, United States, 36608 |
Principal Investigator: | Paul O. Schwarzenberger, M.D. |
Responsible Party: | Charles Broes, CEO, Quantum Immunologics, Inc. |
ClinicalTrials.gov Identifier: | NCT00879489 |
First Posted: | April 10, 2009 Key Record Dates |
Last Update Posted: | February 25, 2011 |
Last Verified: | April 2009 |
Stage IV histologically proven breast cancer |
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases |
Skin Diseases Vaccines Immunologic Factors Physiological Effects of Drugs |