Microsphere-Delivered Cytokines in Increasing Tumor Response in Lymphocytes From Patients With Head and Neck Cancer

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
New York University School of Medicine
ClinicalTrials.gov Identifier:
NCT00899821
First received: May 9, 2009
Last updated: November 8, 2012
Last verified: December 2008
  Purpose

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
Head and Neck Cancer
Biological: aldesleukin
Biological: recombinant interleukin-12
Biological: sargramostim
Other: immunologic technique
Procedure: biopsy

Study Type: Interventional
Official Title: Head And Neck Cancer Immunotherapy Using Biodegradable Microspheres

Resource links provided by NLM:


Further study details as provided by New York University School of Medicine:

Primary Outcome Measures:
  • 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 [ Designated as safety issue: No ]
  • Vaccine potential in provoking or enhancing long-term systemic immunity against head and neck cancer [ Designated as safety issue: No ]
  • Response rate [ Designated as safety issue: No ]

Study Start Date: June 2000
Primary Completion Date: December 2004 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00899821

Sponsors and Collaborators
New York University School of Medicine
Investigators
Study Chair: Moni A. Kuriakose, MD New York University School of Medicine
  More Information

Additional Information:
No publications provided

Responsible Party: New York University School of Medicine
ClinicalTrials.gov Identifier: NCT00899821     History of Changes
Other Study ID Numbers: CDR0000280490, NYU-9916
Study First Received: May 9, 2009
Last Updated: November 8, 2012
Health Authority: United States: Federal Government

Keywords provided by New York University School of Medicine:
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

Additional relevant MeSH terms:
Head and Neck Neoplasms
Neoplasms
Neoplasms by Site
Interleukin-12
Adjuvants, Immunologic
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Antineoplastic Agents
Growth Inhibitors
Growth Substances
Immunologic Factors
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014