Microsphere-Delivered Cytokines in Increasing Tumor Response in Lymphocytes From Patients With Head and Neck Cancer
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|ClinicalTrials.gov Identifier: NCT00899821|
Recruitment Status : Completed
First Posted : May 12, 2009
Last Update Posted : November 9, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Head and Neck Cancer||Biological: aldesleukin Biological: recombinant interleukin-12 Biological: sargramostim Other: immunologic technique Procedure: biopsy||Not Applicable|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Official Title:||Head And Neck Cancer Immunotherapy Using Biodegradable Microspheres|
|Study Start Date :||June 2000|
|Actual Primary Completion Date :||December 2004|
- Local and sustained cytokine combinations in evaluating antitumor response in human peripheral blood lymphocytes obtained from patients with squamous cell carcinoma of the head and neck
- Vaccine potential in provoking or enhancing long-term systemic immunity against head and neck cancer
- Response rate
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00899821
|Study Chair:||Moni A. Kuriakose, MD||New York University School of Medicine|