Clinical trial NCT00899821: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
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
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2009-05-12
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no

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.

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

Primary outcomes:
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
measure: Vaccine potential in provoking or enhancing long-term systemic immunity against head and neck cancer
measure: Response rate
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: NYU Langone Health
name: Moni A. Kuriakose, MD
role: STUDY_CHAIR
References: