Therapeutic Autologous Lymphocytes, Cyclophosphamide, and Aldesleukin in Treating Patients With Stage IV Melanoma
Condition: Recurrent Melanoma; Stage IV Melanoma
MeSH terms: Melanoma
Study type: Interventional
Phase: Phase 1

Summary: 
      RATIONALE: Biological therapies, such as therapeutic autologous lymphocytes, may stimulate
      the immune system in different ways and stop tumor cells from growing. Drugs used in
      chemotherapy, such as cyclophosphamide, work in different ways to stop the growth of tumor
      cells, either by killing the cells or by stopping them from dividing. Cyclophosphamide may
      also stimulate the immune system in different ways and stop tumor cells from growing.
      Aldesleukin may stimulate white blood cells to kill tumor cells. Giving therapeutic
      autologous lymphocytes together with cyclophosphamide and aldesleukin may be an effective
      treatment for melanoma.

      PURPOSE: This phase I trial is studying the side effects of giving therapeutic autologous
      lymphocytes together with cyclophosphamide and aldesleukin in treating patients with stage IV
      melanoma
    

Detailed description: 
      PRIMARY OBJECTIVES:

      I. To assess the safety and toxicity of cellular adoptive immunotherapy in melanoma patients
      receiving autologous CD8+ antigen-specific T cell clones following cyclophosphamide
      conditioning and post-infusion IL-2.

      II. To assess the duration of in vivo persistence of adoptively transferred CD8+ T cell
      clones.

      SECONDARY OBJECTIVES:

      I. Evaluate the antitumor effect of adoptively transferred CD8+ antigenspecific cytotoxic t
      lymphocytes (CTL) clones following cyclophosphamide conditioning and post-infusion IL-2.

      OUTLINE:

      Patients are assigned 1of 2 treatment cohorts.

      All patients receive high-dose cyclophosphamide intravenously (IV) on days -3 and -2 and
      autologous antigen-specific cytotoxic CD8+ T lymphocyte clones IV over 30-60 minutes on day
      0.

      COHORT I: Beginning within 6 hours of T cell infusion, patients receive low-dose aldesleukin
      subcutaneously (SC) twice daily on days 0-14.

      COHORT II: Beginning within 6 hours of T cell infusion, patients receive high-dose
      aldesleukin IV 3 times daily on days 0-5.

      Treatment continues in the absence of disease progression or unacceptable toxicity.

      After completion of study treatment, patients are followed up at 4 weeks, 8 weeks, and every
      3 months thereafter for up to 1 year.
    

Intervention name(s): cyclophosphamide; therapeutic autologous lymphocytes; aldesleukin; immunohistochemistry staining method; biopsy; laboratory biomarker analysis; immunologic technique; polymerase chain reaction
Intervention type(s): Drug; Biological; Biological; Other; Procedure; Other; Other; Genetic
Intervention description(s): Given IV; Given IV; Given IV or SC; Correlative studies; Optional correlative studies; Correlative studies; Correlative studies; Correlative studies
Other intervention name(s): CPM; CTX; Cytoxan; Endoxan; Endoxana; AL; Autologous Lymphocytes; autologous T cells; IL-2; Proleukin; recombinant human interleukin-2; recombinant interleukin-2; immunohistochemistry; biopsies; immunological laboratory methods; laboratory methods, immunological; PCR
Intervention MeSH terms: Aldesleukin; Cyclophosphamide; Interleukin-2
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment