Microsphere-Delivered Cytokines in Increasing Tumor Response in Lymphocytes From Patients With Head and Neck Cancer
Condition: Head and Neck Cancer
MeSH terms: Head and Neck Neoplasms
Study type: Interventional

Summary: 
      RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may
      help doctors learn more about how interleukin-2, interleukin-12, and GM-CSF delivered in
      microspheres increase the body's ability to kill tumor cells.

      PURPOSE: This laboratory study is looking at microsphere-delivered cytokines to see if they
      increase tumor response in lymphocytes from patients with head and neck cancer.
    

Detailed description: 
      OBJECTIVES:

        -  Determine whether local sustained delivery of cytokines (interleukin-2, interleukin-12,
           or sargramostim [GM-CSF]) in biodegradable microspheres augments antitumor response in
           human peripheral blood lymphocytes (PBLs) obtained from patients with squamous cell
           carcinoma of the head and neck, as evaluated in a human/SCID chimeric mouse model.

        -  Assess the potential of cytokine-loaded microspheres combined with dendritic cells
           (pulsed with tumor peptide) obtained from these patients to enhance long-term immunity
           against the tumor, as evaluated in a human/SCID chimeric mouse model.

        -  Evaluate the antitumor effect of the more effective approach (objective I or II) against
           established tumors in the mouse model.

      OUTLINE: Biopsies of tumor are obtained during surgical resection. Patients undergo
      phlebotomy or leukapheresis to obtain peripheral blood lymphocytes (PBLs). PBLs, tumor
      tissue, and cytokine-loaded microspheres are coengrafted into SCID mice. Tumor growth and
      immune response are determined.

      Dendritic cells are obtained from PBLs, expanded in culture, and pulsed with either
      autologous tumor cell lysates or peptide eluted from the tumor cells. The dendritic cells are
      coengrafted with tumor cells, PBLs, and cytokine-loaded microspheres into SCID mice. The mice
      are then challenged with autologous tumor cells, and antitumor response is determined.

      PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.
    

Intervention name(s): aldesleukin; recombinant interleukin-12; sargramostim; immunologic technique; biopsy
Intervention type(s): Biological; Biological; Biological; Other; Procedure
Intervention MeSH terms: Aldesleukin; Interleukin-12; Sargramostim
Keywords: recurrent metastatic squamous neck cancer with occult primary; untreated metastatic squamous neck cancer with occult primary; stage I squamous cell carcinoma of the hypopharynx; stage I squamous cell carcinoma of the larynx; stage I squamous cell carcinoma of the lip and oral cavity; stage I squamous cell carcinoma of the nasopharynx; stage I squamous cell carcinoma of the oropharynx; stage I squamous cell carcinoma of the paranasal sinus and nasal cavity; stage II squamous cell carcinoma of the hypopharynx; stage II squamous cell carcinoma of the larynx; stage II squamous cell carcinoma of the lip and oral cavity; stage II squamous cell carcinoma of the nasopharynx; stage II squamous cell carcinoma of the oropharynx; stage II squamous cell carcinoma of the paranasal sinus and nasal cavity; stage III squamous cell carcinoma of the hypopharynx; stage III squamous cell carcinoma of the larynx; stage III squamous cell carcinoma of the lip and oral cavity; stage III squamous cell carcinoma of the nasopharynx; stage III squamous cell carcinoma of the oropharynx; stage III squamous cell carcinoma of the paranasal sinus and nasal cavity; stage IV squamous cell carcinoma of the hypopharynx; stage IV squamous cell carcinoma of the larynx; stage IV squamous cell carcinoma of the lip and oral cavity; stage IV squamous cell carcinoma of the nasopharynx; stage IV squamous cell carcinoma of the oropharynx; stage IV squamous cell carcinoma of the paranasal sinus and nasal cavity; recurrent squamous cell carcinoma of the hypopharynx; recurrent squamous cell carcinoma of the larynx; recurrent squamous cell carcinoma of the lip and oral cavity; recurrent squamous cell carcinoma of the nasopharynx; recurrent squamous cell carcinoma of the oropharynx; recurrent squamous cell carcinoma of the paranasal sinus and nasal cavity; recurrent salivary gland cancer; salivary gland squamous cell carcinoma; stage I salivary gland cancer; stage II salivary gland cancer; stage III salivary gland cancer; stage IV salivary gland cancer