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Virus Therapy

Treatment (PV701) for Squamous Cell Carcinoma

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
  • Squamous Cell Carcinoma
  • Salivary Gland Carcinoma
  • Laryngeal Squamous Cell Carcinoma
  • Salivary Gland Cancer

Timeline

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.

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,890 Previous Clinical Trials
41,011,919 Total Patients Enrolled
David GustinPrincipal InvestigatorUniversity of Chicago Comprehensive Cancer Center
~1 spots leftby Oct 2025
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