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Safety and Efficacy of Repeat Administration of Ad/PNP and Fludarabine Phosphate in Patients With Local Head/Neck Cancer

NCT03754933 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2025-03-27

Study results available
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Summary

Primary Objective: The primary objective of the study is to evaluate the safety of repeat administration of a dose level of Ad/PNP plus fludarabine phosphate (F-araAMP) which demonstrated anti-tumor activity in patients with advanced head and neck cancer in a completed phase I study.

Secondary Objective: The secondary objective is to evaluate the antitumor activity of repeat administration of Ad/PNP plus F-araAMP.

FDA Office of Orphan Drugs Division is a source of funding for the overall project.

Conditions

  • Recurrent Head and Neck Cancer

Interventions

BIOLOGICAL

Ad/PNP

Ad/PNP is a replication defective adenoviral vector expressing E. coli Purine Nucleoside Phosphorylase

DRUG

Fludarabine Phosphate

Fludarabine phosphate is an anticancer agent currently used for treatment of patients with chronic lymphocytic leukemia.

Sponsors & Collaborators

  • Stanford University

    collaborator OTHER

  • Emory University

    collaborator OTHER

  • Thomas Jefferson University

    collaborator OTHER

  • GeoVax, Inc.

    lead INDUSTRY

Principal Investigators

  • A. Dimitrios Colevas, MD · Stanford University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-02-11
Primary Completion
2023-12-29
Completion
2024-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03754933 on ClinicalTrials.gov