Ad/PNP + Fludarabine for Head and Neck Cancer

Recruiting in Palo Alto (17 mi)

+2 other locations

Overseen byA Dimitrios Colevas, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: PNP Therapeutics, Inc.

No Placebo Group

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

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.

Inclusion Criteria

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

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

Provided Informed Consent

+11 more

Exclusion Criteria

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

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

I had radiation less than 4 weeks ago and all my measurable cancer areas were treated.

+11 more

Participant Groups

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.

1Treatment groups

Experimental Treatment

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

Ad/PNP + fludarabine phosphate, 5 cycles