Phase II Study of Allo LMI Vaccine With IL-2 for Stable Metastatic Breast Ca

Phase 2

Terminated

Conditions: Breast Cancer

Interventions: Biological: allogeneic large multivalent immunogen breast cancer vaccine
Biological: aldesleukin

Registration Number: NCT00784524

Lead Sponsor: Masonic Cancer Center, University of Minnesota

Brief 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.

Detailed Description: OBJECTIVES:

Primary

* To determine the efficacy of allogeneic large multivalent immunogen (LMI) vaccine and aldesleukin, as defined by clinical benefit rate (percentage of patients demonstrating a complete response, partial response, or disease stabilization as assessed by RECIST criteria), in women with stable metastatic breast cancer.

Secondary

* To measure the immune response in patients treated with this regimen.

* To determine the progression-free survival of patients treated with this regimen.

* To determine the 1- and 2-year overall survival rates in patients treated with this regimen.

* To determine the safety profile and toxicity of this regimen in these patients.

OUTLINE: Patients receive allogeneic large multivalent immunogen (LMI) vaccine intradermally on day 1 and aldesleukin subcutaneously on days 7 and 8. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Patients with disease progression after 2 courses of vaccine therapy resume the chemotherapy regimen for which prior disease stabilization was achieved. Beginning 2-4 days after completion of chemotherapy, patients receive one dose of LMI vaccine followed by aldesleukin on days 7 and 8. Patients achieving at least stable disease continue to receive LMI vaccine and aldesleukin as above. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.

Peripheral blood mononuclear cell samples are collected periodically for research studies. Samples are analyzed to assess the frequency of leukocyte subsets (including B cells, T cells, NK cells, and monocytes) via flow cytometry; frequency of T-regs (T cells that express CD4, CD25, and FoxP3); and responses to keyhole limpet hemocyanin and tetanus toxoid via ELISA assay. Other immunological studies are also performed.

After completion of study therapy, patients are followed every 3 months.

Recruitment & Eligibility

Status: TERMINATED

Sex: Female

Target Recruitment: 14

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
LMI Vaccination + IL-2	allogeneic large multivalent immunogen breast cancer vaccine	Patients receiving allogeneic large multivalent immunogen breast cancer vaccine and aldesleukin.
LMI Vaccination + IL-2	aldesleukin	Patients receiving allogeneic large multivalent immunogen breast cancer vaccine and aldesleukin.

Primary Outcome Measures

Name	Time	Method
Disease Response	Up to 2 years	Percentage of patients achieving complete response, partial response, or disease stabilization as assessed by Response Evaluation Criteria In Solid Tumors Criteria (RECIST) criteria for measurable target lesions and non-measurable non-target lesions assessed by CT, PET-CT or MRI: Complete Response (CR), Disappearance of all target and non-target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions or persistence of one or more non-target lesions; Disease Stabilization (SD), Neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease; Progressive Disease (PD), \>=20% increase in the sum of the longest diameter of target lesions or the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions.

Secondary Outcome Measures

Name	Time	Method
Immune Response	48 hours	Immune responses will be assessed by DTH responses to LMI, IFN-gamma production by CD8+ T cells using the ELISPOT assay, and CD8+ T cell binding to HLA-A2 multimers complexed with breast cancer-derived peptides (multimer analysis).
Progression-free Survival	Up to 1 year	Progression free survival will be measured in months from time of response to time of disease progression as defined by RECIST (appendix II), "at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum longest diameter recorded since the baseline measurements, or the appearance of one or more new lesion(s)."
Overall Survival	2 years	Number of participants alive at 2 years