A Phase I Cancer Vaccine Study for Patients With Metastatic Breast Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2009 by Southern Cancer Center
Sponsor:
Collaborators:
Quantum Immunologics, Inc.
University of South Alabama
Information provided by:
Southern Cancer Center
ClinicalTrials.gov Identifier:
NCT00715832
First received: July 10, 2008
Last updated: August 25, 2009
Last verified: August 2009
  Purpose

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 her own, 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 cannulas 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.


Condition Intervention Phase
Metastatic Breast Cancer
Biological: Dendritic Cell Vaccination
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Southern Cancer Center:

Primary Outcome Measures:
  • toxicity [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Response, Survival, Immunological Monitoring, Time to Disease Progression [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 25
Study Start Date: May 2008
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Biological: Dendritic Cell Vaccination
    Autologous dendritic dells will be pulsed with human recombinant oncofetal antigen (OFP/iLRP). The vaccine will be injected intradermally
Detailed Description:

The study is an open-label study to assess safety and immune responses to the universal tumor antigen OFA/iLRP. All patients will be immunized with 1 x 107 viable OFA/iLRP-loaded mature, autologous monocyte-derived dendritic cells (DCs). The DC vaccine will be administered intradermally into the proximal medial upper extremity, contralateral to the original site of breast cancer once every month for 3 months. Changes in the tumor will be documented. The patient will remain in the study unless toxicity or adverse side effects require discontinuation following RECIST and CTC guidelines, or if the patient withdraws for any other reason.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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).
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00715832

Contacts
Contact: Kelli Wilson 251 442 9452 kelliwilson@quantumimmunologics.com
Contact: Sheri Murray, RN, BSN 251/259-5587 sherimurray@quantumimmunologics.com

Locations
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         
Sponsors and Collaborators
Southern Cancer Center
Quantum Immunologics, Inc.
University of South Alabama
  More Information

Publications:
Coggin JH, Jr. Oncofetal antigens. Nature. 1986;319:428.

Responsible Party: Paul Schwarzenberger, MD, Quantum Immunologics http://quantumimmunologics.com
ClinicalTrials.gov Identifier: NCT00715832     History of Changes
Other Study ID Numbers: QI-Breast Vaccine 1
Study First Received: July 10, 2008
Last Updated: August 25, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Southern Cancer Center:
Breast cancer
Dendritic cell vaccine
OFA/iLRP
Patients
Line
Chemotherapy
Setting
Four different lines

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on July 26, 2014