Phase II Study of Allo LMI Vaccine With IL-2 for Stable Metastatic Breast Ca
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: allogeneic large multivalent immunogen breast cancer vaccine; aldesleukin
Intervention description: Allogeneic large multivalent immunogen breast cancer vaccine (1 x 10^7, 5-μm silica spheres) will be given as an intradermal injection every 28 days (+/- 3 days). Each vaccine dose will be 0.2 ml.; Subcutaneous aldesleukin (10 x 10^6 International Units) will be given on day 7 and day 8 after each LMI injection.
Intervention MeSH terms: Aldesleukin; Interleukin-2
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 14.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: stage IV breast cancer; recurrent breast cancer; metastatic breast cancer

Summary:

      RATIONALE: Vaccines may help the body build an effective immune response to kill tumor cells.
      Aldesleukin may stimulate the white blood cells to kill breast cancer cells. Giving vaccine
      therapy together with aldesleukin may be a more effective treatment for metastatic breast
      cancer.

      PURPOSE: This phase II trial is studying how well giving vaccine therapy together with
      aldesleukin works in treating women with metastatic breast cancer.
    

Eligibility criteria:

        Inclusion criteria:

          -  Stage IV, metastatic breast cancer, confirmed by histology or cytology.

               -  Disease must be refractory to hormone therapy for tumors that estrogen and/or
                  progesterone receptor positive

               -  Disease must be refractory to trastuzumab for tumors that are HER2 positive

               -  Disease must be responsive to chemotherapy such that regression or at least
                  stabilization occurs

                    -  Stable disease is defined as neither sufficient shrinkage to qualify for
                       partial response nor sufficient increase to qualify for progressive disease

                    -  Measurement of regressed or stable disease must be confirmed by repeat
                       evaluation no less than 4 weeks after the initial determination.

          -  Prior systemic chemotherapy, immunotherapy, biological therapy, or investigational
             drug therapy is allowed if at least 4 weeks since last treatment.

               -  Patient must recover from the acute toxic effects of the treatment prior to study
                  enrollment.

               -  There is no limit as to the number of previous chemotherapy regimens received.

          -  Disease status may be measurable or non-measurable

          -  Karnofsky performance status >70%

          -  Women, age 18 years or older

          -  Adequate organ function within 14 days of study registration including the following:

               -  Adequate bone marrow reserve: absolute neutrophil (segmented and bands) count
                  (ANC) ≥ 1.5 x 10^9/L, platelets ≥75 x 10^9/L, and hemoglobin ≥ 8.0 g/dL

               -  Hepatic: bilirubin ≤ 3 times the upper limit of normal (× ULN) for patients
                  without tumor involvement of the liver and ≤ 5 X ULN for patients with tumor
                  involvement of the liver; aspartate transaminase (AST) ≤ 2.5 × ULN for patients
                  without tumor involvement of the liver and ≤ 5 X ULN for patients with tumor
                  involvement of the liver

               -  Renal: creatinine ≤ 2.0 mg/dL

          -  Must share at least one class I HLA allele with the HLA-type SKBR3 cell (class I
             alleles A2, A3, B14, B40, C3, C8)

          -  Meets eligibility criteria for and agrees to enroll in "MT1999-06: Vaccination with
             Tetanus Toxoid and Keyhole Limpet Hemocyanin (KLH) to Assess Antigen-Specific Immune
             Responses" (IRB # 9904M01581, CPRC #2002LS032). Patients who have had tetanus toxoid
             within the last 7 years will not receive the tetanus vaccine component. For patients
             who do not know the year of their last tetanus vaccine, tetanus toxoid will be given
             per protocol. Subjects allergic to seafood will not be co-enrolled into MT1996-06.

          -  Women of childbearing potential and their partners are required to use an effective
             method of contraception (ie, a hormonal contraceptive, intra-uterine device, diaphragm
             with spermicide, condom with spermicide, or abstinence) during the study and for 3
             months after the last dose of study drug.

          -  Voluntary written informed consent before performance of any study-related procedure
             not part of normal medical care, with the understanding that consent may be withdrawn
             by the subject at any time without prejudice to future medical care.

        Exclusion criteria:

          -  History of untreated or active brain metastases or positive brain scan at enrollment.
             Patients with previously treated brain metastases are eligible if stable by CT or MRI
             for at least 3 months.

          -  Concurrent malignancy other than non-melanoma skin cancer or carcinoma in situ of the
             cervix

          -  Active infection

          -  Solid organ transplantation or autoimmune diseases requiring systemic
             immunosuppressive therapy; however, topical or inhalational steroids are allowed.

          -  Symptomatic pulmonary disease (symptoms of dyspnea or rales, wheezes or rhonchi on
             physical exam) will require pulmonary function testing (PFTs). Those with FEV1 <50% of
             predicted or corrected DLCO <50% are not eligible.

          -  Patients with cardiac disease such as recent myocardial infarction (< 3 months prior),
             unstable angina, or heart failure requiring medical intervention will undergo cardiac
             evaluation. Cardiac testing may include ECG, MUGA or echocardiogram, and/or thallium
             stress test as indicated to evaluate cardiac risks. Those patients with
             exercise-induced ischemia or an ejection fraction by MUGA or echocardiogram < 40% are
             not eligible.

          -  Hypersensitivity to any component of the vaccine, including Thimerosal, a mercury
             derivative, is a contraindication (taken from tetanus toxoid package insert).

          -  The occurrence of any type of neurologic symptoms to tetanus vaccine in the past is a
             contraindication to further use (taken from tetanus toxoid package insert).

          -  Pregnant (positive pregnancy test) or lactating women. Use of LMI vaccine during
             pregnancy is not approved for use by the FDA during pregnancy. IL-2 is pregnancy
             category C - risk in pregnancy cannot be ruled out.