Intratumoral PV701 in Treating Patients With Advanced or Recurrent Unresectable Squamous Cell Carcinoma of the Head and Neck

Phase 1

Waitlist Available

Led By David Gustin

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 12 weeks

Awards & highlights

No Placebo-Only Group

Summary

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

Eligible Conditions

Nasopharyngeal Cancer
Oral Cancers
Throat Cancer
Nasopharyngeal cancer
Sinus Cancer
Laryngeal Cancer
Salivary Gland Cancer
Laryngeal Squamous Cell Carcinoma
Squamous Cell Carcinoma

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 12 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Response (complete and partial) rate according to Response Evaluation Criteria in Solid Tumors (RECIST) Committee

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (PV701)Experimental Treatment1 Intervention

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.

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