Clinical trial · Interventional
Vaccine Therapy in Treating Patients With Head and Neck Cancer
Adjuvant p53 Peptide Loaded DC-Based Therapy for Subjects With Squamous Cell Cancer of the Head and Neck (A Phase I Safety and Immunogenicity Trial)
NCT00404339CI-TRIAL-00021787completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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 studying the side effects of vaccine therapy in treating patients with head and neck cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| adjuvant therapy | Procedure | — | UNRESOLVED |
| mutant p53 peptide pulsed dendritic cell vaccine | Biological | — | UNRESOLVED |
| tetanus toxoid helper peptide | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (3)
- measure
- Toxicity profile and overall toxicity rates
- measure
- Immunologic response rate as measured by ELISPOT assay prevaccination and at days 14 and 18
- measure
- Biologic response rate
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
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)
References
Publications (0)
Data not yet available
No reference posted for this study.