Head And Neck Cancer Immunotherapy Using Biodegradable Microspheres
20 Years
80 Years
Both
Head and Neck Cancer
Trial Information
Head And Neck Cancer Immunotherapy Using Biodegradable Microspheres
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.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed squamous cell carcinoma of the head and neck
- Tumor tissue shows engraftment in severe combined immunodeficient (SCID) mice or
growth in tissue culture
PATIENT CHARACTERISTICS:
Age
- 20 to 80
Performance status
- Not specified
Life expectancy
- Not specified
Hematopoietic
- Not specified
Hepatic
- Not specified
Renal
- Not specified
Other
- Not pregnant or nursing
- Fertile patients must use effective contraception
- No known immunocompromised disease or condition
- No social, physical, or psychiatric condition that would preclude leukapheresis
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- Not specified
Endocrine therapy
- Not specified
Radiotherapy
- Not specified
Surgery
- Not specified
Other
- No concurrent immunosuppressive medication
Type of Study:
Interventional
Study Design:
N/A
Outcome Measure:
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
Safety Issue:
No
Principal Investigator
Moni A. Kuriakose, MD
Investigator Role:
Study Chair
Investigator Affiliation:
New York University School of Medicine
Authority:
United States: Federal Government
Study ID:
CDR0000280490
NCT ID:
NCT00899821
Start Date:
June 2000
Completion Date:
Related Keywords:
- Head and Neck Cancer
- 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
- Head and Neck Neoplasms
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