Phase I, Open-label Study Evaluating the Safety of Escalating Doses of Ad/PNP-F-araAMP (Ad/PNP Administered Intratumorally With Co-administration of Fludarabine Phosphate Intravenously) in Subjects With Advanced Solid Tumors
For this first study, we will inject the PNP-loaded adenovirus into the tumors of patients
with cancers primarily in the throat and neck and then give them the drug. This study is
designed with two goals in mind: 1) assessing the overall safety of this approach for the
patient; and 2) observing the effects of this anti-cancer strategy on the tumor itself.
This will be accomplished in two parts. First, we will introduce a modest, fixed amount of
the gene-carrying adenovirus into the tumors of three separate groups of patients and then
administer small, increasingly strong amounts of the fludarabine phosphate to each
successive group over a three-day period. Even in the group that will receive the highest
amount of fludarabine, the total amount given to any individual patient over those three
days will be significantly less than the dose approved by the FDA for patients with
non-solid tumors. Finally, a more concentrated amount of the adenovirus (approximately 10
times more viruses) will be given to a fourth group of patients who will also receive the
highest dose of the drug that was shown to be well tolerated in the prior three groups (the
highest dose at which no serious problems were observed).
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Evaluation of the safety of Ad/PNP-F-araAMP
The number of subjects with adverse events as a measure of safety across the 4 dose cohorts.
Entry through Study Day 56
United States: Food and Drug Administration
|Vanderbilt-Ingram Cancer Center||Nashville, Tennessee 37232-6838|
|University of Alabama at Birmingham||Birmingham, Alabama 35294-3300|