Safety and Effectiveness of Repeated Treatment with Ad/PNP and Fludarabine Phosphate for Local Head and Neck Cancer

Sponsor: GeoVax, Inc.

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT03754933

Provider View

This study is testing the safety and effectiveness of giving repeated doses of a treatment called Ad/PNP combined with fludarabine phosphate to patients with advanced head and neck cancer. The study is funded by the FDA's Office of Orphan Drugs Division.

Patient Parameters

Program Overview

The main goal of this study is to see if it is safe to give repeated doses of a treatment called Ad/PNP with fludarabine phosphate to patients with advanced head and neck cancer. This treatment showed promise in an earlier study. The study also aims to see how well this treatment works in shrinking tumors. The FDA's Office of Orphan Drugs Division is funding this research.

Description

This study involves a treatment called Ad/PNP-F-araAMP, which is a combination of a special virus and a drug called fludarabine phosphate. The virus is injected directly into the tumor, and the drug is given through an IV. Together, they create a substance that targets and attacks the cancer cells in the tumor.

In earlier studies, this treatment showed potential in shrinking tumors in patients with head and neck cancer. The study will test if giving this treatment multiple times is safe and effective. Patients will receive the treatment every four weeks for up to five cycles, or until the tumor grows, side effects become too severe, or there is no tumor left to treat.

The study will monitor the tumor's response through physical exams and imaging tests. Patients will be closely watched for any side effects during the study.

Eligibility Criteria

Inclusion Criteria

  • Must provide informed consent to participate.
  • Must be 18 years or older.
  • Must have a confirmed diagnosis of recurrent head and neck cancer with no other treatment options available.
  • Must have tried all standard treatments, or be unable or unwilling to use them.
  • Must have a tumor that can be measured and is suitable for injection.
  • Must have a performance status score of 2 or less, meaning they are able to carry out light work.
  • Must have recovered from any previous treatment side effects.
  • Must have adequate blood cell counts and organ function as determined by specific tests.
  • Female patients must have a negative pregnancy test and agree to use contraception.
  • All patients of reproductive potential must agree to use contraception or abstain from sex.

Exclusion Criteria

  • History or current diagnosis of leukemia.
  • Have received gene therapy or viral therapy before.
  • Currently taking allopurinol.
  • Have taken an investigational drug within 30 days before starting the study treatment.
  • Have received radiation or chemotherapy recently and not recovered from side effects.
  • Have significant nerve damage or uncontrolled health conditions.
  • Have had serious heart or liver issues recently.
  • Have a fever over 38.1°C.
  • Taking long-term steroids or immunosuppressive drugs.
  • Taking blood thinners, except for maintaining IV lines.
  • Pregnant or breastfeeding women.
  • History of HIV infection.

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.