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Virus Therapy

Ad/PNP + Fludarabine for Head and Neck Cancer

Phase 1 & 2

Waitlist Available

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.

Must not have

Uncontrolled intercurrent disease (e.g., diabetes, hypertension, thyroid disease, active infection)

Receiving anticoagulants other than those to maintain patency of venous lines

Timeline

Screening 3 weeks

Treatment Varies

Follow Up six months

Awards & highlights

No Placebo-Only Group

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.

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.

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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I am 18 years old or older.

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My liver function tests are within normal limits.

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I can perform all self-care but cannot work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have any uncontrolled diseases like diabetes or high blood pressure.

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I am on blood thinners not just for keeping my veins open.

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I have a history of HIV.

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I haven't had a heart attack, stroke, severe heart failure, liver disease, or unstable chest pain in the last 6 months.

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I do not have severe nerve pain or damage.

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I am currently taking allopurinol.

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I am not pregnant or breastfeeding.

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I have had a fever over 38.1°C.

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I have received gene therapy or viral therapy for cancer.

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I have or had leukemia.

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

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

Primary study objectives

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 study objectives

Best Overall Response (ORR) per RECIST 1.1.

Duration of treatment response

Progression Free Survival (PFS)