Clinical trial · Interventional
Intratumoral PV701 in Treating Patients With Advanced or Recurrent Unresectable Squamous Cell Carcinoma of the Head and Neck
A Phase I Study Of PV701 In Patients With Head And Neck Squamous Cell Carcinoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Administratively complete.
Summary
Brief summary (as posted)
Phase I trial to study the effectiveness of intratumoral (in the tumor) PV701 in treating patients who have advanced or recurrent unresectable squamous cell carcinoma (cancer) of the head and neck. Vaccines made from a specially-modified virus such as PV701 may make the body build an immune response to kill tumor cells while leaving normal cells undamaged. Injecting PV701 directly into the tumor may cause a stronger immune response and kill more tumor cells
Conditions
Conditions (22)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Recurrent Salivary Gland Cancer | Malignant Salivary Gland Neoplasm | CURATED_BROADER | 0.78 |
| Recurrent Squamous Cell Carcinoma of the Hypopharynx | Hypopharyngeal Squamous Cell Carcinoma | CURATED_BROADER | 0.78 |
| Recurrent Squamous Cell Carcinoma of the Larynx | Laryngeal Squamous Cell Carcinoma | CURATED_BROADER | 0.78 |
| Recurrent Squamous Cell Carcinoma of the Lip and Oral Cavity | — | UNRESOLVED | — |
| Recurrent Squamous Cell Carcinoma of the Nasopharynx | — | UNRESOLVED | — |
| Recurrent Squamous Cell Carcinoma of the Oropharynx | Oropharyngeal Squamous Cell Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PV701 | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (PV701)
- description
- Patients receive intratumoral PV701 once weekly for 3 weeks. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of PV701 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, at least 6 evaluable patients are treated at that dose.
- interventionNames
- Biological: PV701
Primary outcomes (1)
- measure
- Maximum-tolerated dose (MTD) of PV701 based on the incidence of dose-limiting toxicity (DLT) as assessed by NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0
- timeFrame
- 3 weeks
Secondary outcomes (3)
- measure
- Toxicity as assessed by NCI CTCAE version 3.0
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically or cytologically confirmed squamous cell carcinoma of the head and neck * Locally advanced or recurrent disease * Distant metastases in addition to locally advanced disease acceptable * Not amenable to available standard treatment or palliative measures * At least one target lesion accessible for intratumoral injection, less than 4 cm, and not situated near an airway or major artery * Tumor volume(s) must be large enough to receive injection * No known brain metastases * Performance status - ECOG 0-2 * More than 3 months * WBC \>= 3,000/mm\^3 * Hemoglobin \> 10 g/dL (transfusion permitted) * Platelet count \>= 100,000/mm\^3 * Bilirubin \< 2 times upper limit of normal (ULN) * AST/ALT =\< 2.5 times ULN * Creatinine \< 2.5 mg/dL * No uncontrolled symptomatic congestive heart failure * No unstable angina pectoris * No cardiac arrhythmia * No history of significantly compromised pulmonary function (i.e. FEV\_1 \< 50% of predicted) or decreased oxygen saturation of \< 95% on room air * No history of allergy to eggs or egg-based or chicken embryo-based vaccines * No frequent contact with immunocompromised individuals * No ongoing or active infection * No psychiatric illness or social situation that would preclude study compliance * No history of diabetes mellitus requiring oral hypoglycemic agents or insulin * No HIV-positive patients receiving combination antiretroviral therapy * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * More than 4 weeks since prior chemotherapy and recovered * More than 4 weeks since prior radiotherapy and recovered * More than 4 weeks since prior surgery and recovered * No other concurrent investigational agents or commercial agents or therapies for treatment of malignancy * No concurrent antiviral therapy
References
Publications (0)
Data not yet available