Biological Therapy in Treating Women With Stage IV Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      RATIONALE: Biological therapies use different ways to stimulate the immune system and stop
      cancer cells from growing. Combining different types of biological therapies may kill more
      tumor cells.

      PURPOSE: Phase I/II trial to study the effectiveness of combining different biological
      therapies in treating women who have stage IV breast cancer.
    

Detailed description: 
      OBJECTIVES:

        -  Determine the maximum tolerated dose of armed activated T cells given in combination
           with interleukin-2 and sargramostim (GM-CSF) in women with stage IV breast cancer.

        -  Determine the toxicity profile of this regimen in these patients.

        -  Determine the clinical response and overall and progression-free survival of patients
           treated with this regimen.

      OUTLINE: This is a dose-escalation study of armed activated T cells.

      Patients undergo peripheral blood mononuclear cell (PBMC) collection. The PBMCs are treated
      ex vivo with monoclonal antibody OKT3 to form armed activated T cells (ATC). The armed ATC
      are expanded for 14 days in interleukin-2 (IL-2).

      Patients receive armed ATC IV over 30 minutes twice weekly for 4 weeks. Patients also receive
      IL-2 subcutaneously (SC) once daily and sargramostim (GM-CSF) SC twice weekly beginning 3
      days before the first infusion of armed ATC and continuing until 7 days after the last
      infusion of armed ATC.

      Cohorts of 3-6 patients receive escalating doses of armed ATC until the maximum tolerated
      dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2
      of 6 patients experience dose-limiting toxicity. Once the MTD is determined, additional
      patients are treated at that dose.

      Patients are followed at 1, 2, and 5 months and then every 6 months thereafter.

      PROJECTED ACCRUAL: A total of 15-30 patients will be accrued for the phase I portion of this
      study and a total of 18-33 patients will be accrued for the phase II portion of this study
      within 4-6 years.

      PLEASE NOTE: THIS STUDY WAS INTENDED TO BE A PHASE I/II STUDY, BUT NEVER MOVED FORWARD TO
      PHASE II. (4-22-09)
    

Intervention name(s): Aldesleukin; Sargramostim; therapeutic autologous lymphocytes
Intervention type(s): Biological; Biological; Biological
Intervention description(s): Subcutaneous injections of IL-2 (3.0 × 105 IU/m2/day) starting 3 days before the 1st armed ATC infusion and ending 7 days after the last armed ATC infusion.; GM-CSF Injections will be given SQ GM-CSF (250 μg/m2/twice weekly), to start 3 days before the first ATC infusion and ending 1 week after the last ATC infusion.; The time for armed-ATC infusions will vary from patient to patient, but the dose of armed-ATC (up to 40 billion) will be given over 30 min.
Other intervention name(s): Proleukin ®; IL-2; LeukineTM; GM-CSF; Granulocyte-Macrophage Colony Stimulating Factor
Intervention MeSH terms: Aldesleukin; Molgramostim; Sargramostim
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: stage IV breast cancer; recurrent breast cancer; ductal breast carcinoma