Cellular Immunotherapy Study With Autologous Dendritic Cells Loaded With Oncofetal Antigen/iLRP in Patients With Metastatic Breast Cancer

February 23, 2011 updated by: Quantum Immunologics, Inc.

Phase I/II Cellular Immunotherapy Study With Autologous Dendritic Cells Loaded With Oncofetal Antigen/iLRP in Patients With Metastatic Breast Cancer

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

24

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Mobile, Alabama, United States, 36608
        • Quantum Immunologics, Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Toxicity
Time Frame: 24 months
24 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Response, Survival, Immunological Monitoring, Time to Disease Progression
Time Frame: 24 months
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Quantum Immunologics, Inc.

Collaborators

University of South Alabama

Investigators

  • Principal Investigator: Paul O. Schwarzenberger, M.D.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2008

Primary Completion (ANTICIPATED)

March 1, 2011

Study Completion (ANTICIPATED)

September 1, 2011

Study Registration Dates

First Submitted

April 9, 2009

First Submitted That Met QC Criteria

April 9, 2009

First Posted (ESTIMATE)

April 10, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

February 25, 2011

Last Update Submitted That Met QC Criteria

February 23, 2011

Last Verified

April 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCT00715832

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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