Status:
COMPLETED
Vaccine Therapy in Treating Patients With Head and Neck Cancer
Lead Sponsor:
Robert Ferris
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Head and Neck Cancer
Eligibility:
All Genders
18-120 years
Phase:
PHASE1
Brief Summary
RATIONALE: Vaccines made from a person's dendritic cells mixed with peptides may help the body build an effective immune response to kill tumor cells. PURPOSE: This randomized phase I trial is studyi...
Detailed Description
OBJECTIVES: Primary * Determine the toxicity of intranodally injected autologous dendritic cells (DC) loaded with wild-type p53 peptides with or without T-helper peptide epitope in patients with squ...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed squamous cell carcinoma of the head and neck
- Resectable disease
- Any stage allowed
- Successfully treated with curative intent
- Recurrent disease allowed provided the following criteria are met:
- No evidence of disease
- At least 6 weeks since prior antitumor therapy
- Positive for HLA-A2.1
- HLA-DR4 allele status known
- Tumor tissue must be available
- No active brain metastases
- PATIENT CHARACTERISTICS:
- ECOG performance status 0 or 1
- Life expectancy ≥ 6 months
- Granulocyte count \> 2,500/mm\^3
- Lymphocyte count \> 700/mm\^3
- Platelet count \> 100,000/mm\^3
- Bilirubin \< 0.2 mg/dL
- Creatinine \< 0.2 mg/dL
- Hemoglobin \> 8 g/dL
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception for ≥ 1 week before, during, and for ≥ 2 weeks after study completion
- No systemic infection or coagulation disorders
- No psychiatric disturbances that would preclude obtaining informed consent or safe conduct of protocol
- HIV negative
- Hepatitis B surface antigen and hepatitis C antibody negative
- No other active malignancies
- PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- At least 6 weeks since prior adjuvant radiotherapy or chemoradiotherapy
- No time restriction for prior curative therapy
- No concurrent pharmacological doses of steroids in any form (topical or systemic)
Exclusion
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2014
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT00404339
Start Date
September 1 2005
End Date
March 1 2014
Last Update
April 18 2016
Active Locations (1)
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1
UPMC Cancer Centers
Pittsburgh, Pennsylvania, United States, 15232