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Virus Therapy

Ad/PNP + Fludarabine for Head and Neck Cancer

Phase 1 & 2

Recruiting

Led By A. Dimitrios Colevas, MD

Research Sponsored by PNP Therapeutics, Inc.

Eligibility Criteria Checklist

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

Must have

Serum creatinine ≤ 1.5 mg/dl, or calculated creatinine clearance ≥ 60 ml/min

Patients with histologically or cytologically confirmed diagnosis of recurrent cancer of the head and neck region for whom there is no curative treatment option. For the purposes of trial eligibility, cancers of the head and neck shall include, in addition to head and neck squamous cell carcinoma (HNSCC), cutaneous squamous cell primary sites and squamous cell carcinoma of unknown primary presenting with neck lymph nodal disease, as well as nasopharyngeal carcinoma, and salivary gland tumors.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up six months

Awards & highlights

Study Summary

This trial is testing a repeat dose of a cancer drug combo to see if it's safe and effective against advanced head and neck cancer.

Who is the study for?

Adults with advanced head and neck cancer, for whom no curative treatments are available. They must be in relatively good health with stable organ function and blood counts, not have received certain recent treatments or have uncontrolled diseases, agree to use contraception if of reproductive potential, and have tumors suitable for injection.Check my eligibility

What is being tested?

The trial is testing the safety and tumor-fighting ability of repeated doses of Ad/PNP combined with Fludarabine Phosphate in patients who showed a positive response in an earlier phase I study. The funding comes from the FDA Office of Orphan Drugs Division.See study design

What are the potential side effects?

While specific side effects aren't listed here, common ones may include reactions at the injection site, general discomfort or pain, fatigue, changes in blood counts leading to increased infection risk or bleeding problems, liver or kidney issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My kidney function is normal, based on creatinine levels or clearance.

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My cancer in the head or neck area cannot be cured with treatment.

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My tumor can be measured and is suitable for direct injections, even if I have other tumors that can't be injected.

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I am 18 years old or older.

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All standard treatments have failed or I can't use them due to side effects.

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My liver function tests are within normal limits.

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I have recovered from major side effects of my previous treatments.

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I am not pregnant or I am incapable of becoming pregnant due to surgery or menopause.

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I can perform all self-care but cannot work.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ six months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~six months

This trial's timeline: 3 weeks for screening, Varies for treatment, and six months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Safety as measured by the number of adverse events Grade 2 and above that are considered by investigator to be definitely, probably, or possibly related to study treatment, graded according to Common Terminology Criteria for Adverse Effects v. 4.0

Secondary outcome measures

Best Overall Response (ORR) per RECIST 1.1.

Duration of treatment response

Progression Free Survival (PFS)

Trial Design

1Treatment groups

Experimental Treatment

Group I: Ad/PNP + fludarabine phosphate, 5 cyclesExperimental Treatment2 Interventions

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Fludarabine Phosphate

1997

Completed Phase 3

~2390

0 / 9Eligibility criteria met

Find a Location

Who is running the clinical trial?

Thomas Jefferson UniversityOTHER

445 Previous Clinical Trials

145,704 Total Patients Enrolled

PNP Therapeutics, Inc.Lead Sponsor

1 Previous Clinical Trials

12 Total Patients Enrolled

GeoVax, Inc.Lead Sponsor

5 Previous Clinical Trials

497 Total Patients Enrolled

Media Library

Ad/PNP (Virus Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03754933 — Phase 1 & 2

Head and Neck Cancers Research Study Groups: Ad/PNP + fludarabine phosphate, 5 cycles

Head and Neck Cancers Clinical Trial 2023: Ad/PNP Highlights & Side Effects. Trial Name: NCT03754933 — Phase 1 & 2

Ad/PNP (Virus Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03754933 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many individuals have signed up for participation in this experiment?

"Affirmative. The corroborating evidence on clinicaltrials.gov states that this research is actively recruiting subjects, having posted the study in February 2019 and updated it most recently on August 10th 2022. As of now, there are still 10 spots for participants at a single medical location."

Answered by AI

Is enrollment open for this research trial?

"This trial, with its inception on February 11th 2019 and most recent update August 10th 2022, is still recruiting candidates as reported by clinicialtrials.gov."

Answered by AI

Could you elaborate on the research conducted concerning Fludarabine Phosphate?

"At present, 369 trials researching Fludarabine Phosphate are under operation with 22 of these studies taking place in Phase 3. Numerous clinical sites are conducting this research throughout the world, particularly so in Boston; however, there is a total of 3764 locations running tests for Fludarabine Phosphate."

Answered by AI

Recent research and studies

Current Pharmaceutical DesignJournal

Use of E. Coli Purine Nucleoside Phosphorylase in the Treatment of Solid Tumors

Parker, William B., and Eric J. Sorscher. 2018. “Use of E. Coli Purine Nucleoside Phosphorylase in the Treatment of Solid Tumors”. Current Pharmaceutical Design. Bentham Science Publishers Ltd.. doi:10.2174/1381612823666171109101851.

Annals of OncologyJournal

Phase I Dose-escalating Trial of Escherichia Coli Purine Nucleoside Phosphorylase and Fludarabine Gene Therapy for Advanced Solid Tumors

Rosenthal, E.L., T.K. Chung, W.B. Parker, P.W. Allan, L. Clemons, D. Lowman, J. Hong, et al.. 2015. “Phase I Dose-escalating Trial of Escherichia Coli Purine Nucleoside Phosphorylase and Fludarabine Gene Therapy for Advanced Solid Tumors”. Annals of Oncology. Elsevier BV. doi:10.1093/annonc/mdv196.

Annals of OncologyJournal

Phase I Dose-escalating Trial of Escherichia Coli Purine Nucleoside Phosphorylase and Fludarabine Gene Therapy for Advanced Solid Tumors

clinicaltrials.govStudy

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