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Sponsors and Collaborators: |
New York University School of Medicine National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00899821 |
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 | Intervention |
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Head and Neck Cancer |
Biological: aldesleukin Biological: recombinant interleukin-12 Biological: sargramostim Other: immunologic technique Procedure: biopsy |
Study Type: | Observational |
Official Title: | Head And Neck Cancer Immunotherapy Using Biodegradable Microspheres |
Study Start Date: | June 2000 |
Primary Completion Date: | December 2004 (Final data collection date for primary outcome measure) |
OBJECTIVES:
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.
Ages Eligible for Study: | 20 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Study ID Numbers: | CDR0000280490, NYU-9916 |
Study First Received: | May 9, 2009 |
Last Updated: | May 16, 2009 |
ClinicalTrials.gov Identifier: | NCT00899821 History of Changes |
Health Authority: | United States: Federal Government |
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 |
Anti-Infective Agents Anti-HIV Agents Nasopharyngeal Carcinoma Interleukin-12 Immunologic Factors Laryngeal Carcinoma Adjuvants, Immunologic Squamous Cell Carcinoma Antiviral Agents Angiogenesis Inhibitors |
Recurrence Carcinoma Hypopharyngeal Cancer Aldesleukin Anti-Retroviral Agents Metastatic Squamous Neck Cancer With Occult Primary Head and Neck Neoplasms Epidermoid Carcinoma Carcinoma, Squamous Cell Salivary Gland Diseases |
Anti-Infective Agents Anti-HIV Agents Interleukin-12 Immunologic Factors Antineoplastic Agents Growth Substances Physiological Effects of Drugs Adjuvants, Immunologic Antiviral Agents Angiogenesis Inhibitors |
Pharmacologic Actions Neoplasms Neoplasms by Site Aldesleukin Anti-Retroviral Agents Therapeutic Uses Head and Neck Neoplasms Angiogenesis Modulating Agents Growth Inhibitors |