Clinical trial · Interventional
Dendritic Cell Vaccine for Head and Neck Cancer
0608 GCC:Phase I Study of Intra-tumoral Injection of Dendritic Cells for the Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): major amendments in progress
Summary
Brief summary (as posted)
This research study is testing a new treatment of cancer of the head and neck. Purpose This research study is being done to: 1. Test the safety of the experimental cancer vaccine made of dendritic cells. An experimental vaccine is one that is not approved by the Food and Drug Administration (FDA). 2. To learn what effects (good and bad) the vaccine will have on you and your head and neck cancer. 3. To learn if the vaccine will stimulate your body's white blood cells, which are part of your immune system (your body's natural defense system).
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 |
|---|---|---|---|
| Squamous Cell Carcinoma of Head and Neck | Head and Neck Squamous Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| dendritic cell vaccine | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- safety
- timeFrame
- 5 years
- measure
- Efficacy as measured by RECIST criteria
- timeFrame
- 5 years
Secondary outcomes (1)
- measure
- Characterize the immune response to the vaccine
- timeFrame
- 2 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria:
* Squamous cell carcinoma of the head and neck in patients with unresectable recurrent disease or distant metastasis or patients who fail conventional radiation therapy and/or chemotherapy and refuse surgical salvage.
* Presence of cervical metastasis that is able to be accessed for injection
* Biopsy accessible tumor (metastatic or primary)
* \>18 years of age.
* The following laboratory values obtained ≤14 days prior to registration:
* ANC ≥1500
* PLT ≥100,000
* Hgb ≥ 9.0 g/dL
* Alkaline phosphatase ≤3 x UNL
* AST ≤3 x UNL
* Creatinine ≤1.5 x UNL
* Life expectancy ≥6 months.
* ECOG performance status 0, 1, or 2.
* No chemotherapy for prior 4 weeks.
Exclusion Criteria:
* Pregnant women.
* Nursing women.
* Men or women of childbearing potential who are unwilling to employ adequate contraception (condoms, diaphragm, birth control pills, injections, intrauterine device {IUD}, abstinence.)
* Known HIV infection.
* Concurrent use of systemic immunosuppressants.
* Other immunocompromising condition that in the opinion of the physician renders the patient a poor candidate for this trial.
* Other active cancer requiring therapy to control the disease.
* Unwillingness to return for follow-up evaluations over a period of up to 2 years following completion of protocol therapy.
* Other intercurrent medical problems that, in the opinion of the investigator, would make participation in the study hazardous for the patient
* Patients in whom the otolaryngologist, radiation oncologist, and medical oncologist can not agree on a consensus node to treat.
* Patients with CNS metastasis or involvement of sites where an inflammatory response would constitute an immediately life threatening situation.References
Publications (0)
Data not yet available