Microsphere-Delivered Cytokines in Increasing Tumor Respo... | NCT00899821 | Trialant
NCT00899821
Sponsor
NYU Langone Health
Status
Completed
Last Update Posted
Nov 9, 2012Estimated
Enrollment
Not provided
Phase
Not Applicable
Conditions
Head and Neck Cancer
Interventions
aldesleukin
recombinant interleukin-12
sargramostim
immunologic technique
biopsy
Countries
Not provided
Protocol Section
Identification Module
NCT ID
Results Section
No data available
No data is available for this block.
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
NCT00899821
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
CDR0000280490
Secondary IDs
ID
Type
Description
Link
NYU-9916
Brief Title
Microsphere-Delivered Cytokines in Increasing Tumor Response in Lymphocytes From Patients With Head and Neck Cancer
Official Title
Head And Neck Cancer Immunotherapy Using Biodegradable Microspheres
Acronym
Not provided
Organization
NYU Langone HealthOTHER
Status Module
Record Verification Date
Dec 2008
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Jun 2000
Primary Completion Date
Dec 2004Actual
Completion Date
Not provided
First Submitted Date
May 9, 2009
First Submission Date that Met QC Criteria
May 9, 2009
First Posted Date
May 12, 2009Estimated
Results Waived
Not provided
Results First Submitted Date
Not provided
Results First Submitted that Met QC Criteria
Not provided
Results First Posted Date
Not provided
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Nov 8, 2012
Last Update Posted Date
Nov 9, 2012Estimated
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
NYU Langone HealthOTHER
Collaborators
Name
Class
National Cancer Institute (NCI)
NIH
Oversight Module
No data available
No data is available for this block.
Description Module
Brief 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.
Conditions Module
Conditions
Head and Neck Cancer
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
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Not Applicable
Interventional Study Design
No data available
No data is available for this block.
Biospecimen
No data available
No data is available for this block.
Enrollment
Not provided
Arms/Interventions Module
Arm Groups
Not provided
Interventions
Name
Type
Description
Arm Group Labels
Other Names
aldesleukin
Biological
recombinant interleukin-12
Biological
sargramostim
Biological
immunologic technique
Other
biopsy
Procedure
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
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
Secondary Outcomes
Not provided
Other Outcomes
Not provided
Eligibility Module
Eligibility 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
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
20 Years
Maximum Age
80 Years
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Moni A. Kuriakose, MD
NYU Langone Health
Study Chair
Locations
Not provided
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
No data available
No data is available for this block.
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
ID
Term
D006258
Head and Neck Neoplasms
D000077195
Squamous Cell Carcinoma of Head and Neck
D012468
Salivary Gland Neoplasms
Ancestor Terms
ID
Term
D009371
Neoplasms by Site
D009369
Neoplasms
D002294
Carcinoma, Squamous Cell
D002277
Carcinoma
Browse Leaves
Not provided
Browse Branches
Not provided
Intervention Browse Module
MeSH Terms
ID
Term
C082598
aldesleukin
D053765
Interleukin-12 Subunit p35
C081222
sargramostim
D007158
Immunologic Techniques
D001706
Biopsy
Ancestor Terms
ID
Term
D018664
Interleukin-12
D007378
Interleukins
D016207
Cytokines
D036341
Intercellular Signaling Peptides and Proteins
Browse Leaves
Not provided
Browse Branches
Not provided
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