Head and Neck Cancer Clinical Trial
Official title:
Head And Neck Cancer Immunotherapy Using Biodegradable Microspheres
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.
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.
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