TACTIC - TAA Specific Cytotoxic T Lymphocytes in Patients With Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: TAA-specific CTLs
Intervention description: Each patient will receive 2 injections at a fixed dose, 28 days apart, according to the following dose schedule: The expected volume of infusion will be 1 to 10 cc.
Dose schedule:
Day 0: 2 x 10^7 cells/m2
Day 28: 2 x 10^7 cells/m2
If patients have stable disease or a partial response by the Response Evaluation Criteria in Solid Tumors (RECIST) criteria at their 6 week evaluation after the 2nd cell dose, they will be eligible to receive up to 6 additional doses of CTLs, At least one month should have passed before each additional dose.. Each additional infusion will consist of the same cell number or less (if there is not enough product available for the subject's original dose) than their second infusion. Patients will not be able to receive additional doses until the initial safety profile is completed at 6 weeks following the second infusion.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 12.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Breast Cancer; Tumor Associated Antigen Specific T cells

Summary:

      Status - CLOSED TO PATIENT ENROLLMENT (CNPE)

      The study is being conducted in patients in which breast cancer has come back after standard
      treatment. Volunteers in this research study are treated using special immune system cells
      called tumor-associated antigen (TAA)-specific cytotoxic T lymphocytes, a new experimental
      therapy.

      The proteins that investigators are targeting in this study are called tumor-associated
      antigens (TAAs). These are cell proteins that are specific to the cancer cell. They do not
      show, or they show up in low quantities, on normal human cells. In this study, investigators
      target five common TAAs. They are called NY-ESO-1, MAGEA4, PRAME, Survivin and SSX2. On a
      different study, patients have been treated and so far this treatment has shown to be safe.

      Investigators now want to try this treatment in patients with breast cancer.

      These TAA-specific cytotoxic T lymphocytes (TAA-CTLs) are an investigational product not
      approved by the Food and Drug Administration.

      The purpose of this study is to determine the clinical efficacy of TAA-specific CTLs, to
      learn what the side-effects are, and to see whether this therapy might help patients with
      breast cancer.
    

Eligibility criteria:

        Status - CLOSED TO PATIENT ENROLLMENT (CNPE)

        PROCUREMENT INCLUSION CRITERIA:

          1. Any breast cancer patient with metastatic or locally recurrent unresectable disease.

          2. Patients with life expectancy greater than or equal to 12 weeks.

          3. Age greater than or equal to 18 and less than or equal to 80 years old.

          4. Hgb greater than or equal to 7.0.

          5. Informed Consent explained to, understood by and signed by patient. Patient given copy
             of informed consent.

        TREATMENT INCLUSION CRITERIA:

          1. Any breast cancer patient with metastatic or locally recurrent unresectable breast
             cancer currently progressive, after at least two prior lines of therapy in the
             advanced setting. Patients with HER2+ disease must have failed two or more different
             anti-HER2 agents.

          2. Patients must have measurable or evaluable disease per RECIST 1.1 criteria.

          3. Patients with life expectancy greater than or equal to 12 weeks.

          4. Age greater than or equal to 18 and less than or equal to 80 years old.

          5. Pulse oximetry of greater than 95% on room air.

          6. Patients with ECOG score less than or equal to 2 or a Karnofsky score of greater than
             or equal to 50.

          7. Patients with bilirubin less than or equal to 2x upper limit of normal, AST less than
             or equal to 3x upper limit of normal, and Hgb greater than or equal to 7.0.

          8. Patients with a creatinine normal for age.

          9. Patients should have been off other investigational therapy for one month prior to
             receiving treatment on this study.

         10. Patients should have been off conventional therapy for at least 1 week prior to
             receiving treatment on this study.

         11. Sexually active patients must be willing to utilize one of the more effective birth
             control methods for 6 months after the T cell infusion.

         12. Informed Consent explained to, understood by and signed by patient. Patient given copy
             of informed consent.

        PROCUREMENT EXCLUSION CRITERIA:

          1. Patients with severe intercurrent infection.

          2. Patients with active HIV infection at time of procurement.

          3. Patients with a chronic uncontrolled medical condition that, in the opinion of the
             principal investigator, precludes them from participation.

        TREATMENT EXCLUSION CRITERIA:

          1. Patients with severe intercurrent infection.

          2. Patients receiving systemic corticosteroids (Patients off steroids for at least 48
             hours are eligible).

          3. Pregnant or lactating.

          4. Patients with a chronic uncontrolled medical condition that, in the opinion of the
             principal investigator, precludes them from participation.

          5. HIV positive.