Trial Search Results
Safety and Efficacy of Repeat Administration of Ad/PNP and Fludarabine Phosphate in Patients With Local Head/Neck Cancer
The purpose of this study is to learn whether repeated injections of Ad/PNP given with Fludarabine are able to shrink, delay or prevent growth of cancer tumors in patients with head and neck cancer.
Stanford is currently accepting patients for this trial.
PNP Therapeutics, Inc.
Collaborator: Food and Drug Administration (FDA)
- Biological: Ad/PNP
- Drug: Fludarabine Phosphate
Phase 1/Phase 2
1. Provided Informed Consent
2. Age ≥ 18 years
3. Patients with histologically or cytologically confirmed diagnosis of recurrent HNSCC
for whom there is no curative treatment option. For the purposes of trial eligibility,
HNSCC may include, in addition to the usual mucosal sites, cutaneous squamous cell
primary sites and squamous cell carcinoma of unknown primary presenting with neck
lymph nodal disease, and nasopharyngeal carcinoma.
4. All standard or approved treatment options that would provide substantive palliation
must have failed, been exhausted, or patient not eligible or willing to use them (for
example neuropathy, nephropathy , or hearing loss precluding the use of cisplatin)
5. Tumor mass (primary tumor and/or lymphadenopathy) technically suitable for IT
injections (otolaryngologist will determine feasibility). Patients with nodal disease
(or metastatic disease) that is needle accessible are eligible. Patients with
additional tumors (including distant metastatic disease) beyond the IT injection
accessible tumor(s) that are not accessible for intratumoral injection are eligible
only if the patient has no other curative treatment option for the metastatic disease
and treatment of local disease may provide the patient some benefit or palliation.
6. Eastern Cooperative Oncology Group performance status of ≤ 2
7. In the judgment of the Investigator, the patient has recovered sufficiently from any
previous significant therapy side effects or toxicities prior to Ad/PNP
8. Absolute neutrophil count ≥ 1,500 cells/ul; hemoglobin ≥ 9 g/dl, platelets ≥
9. Serum creatinine ≤ 1.5 mg/dl, or calculated creatinine clearance ≥ 60 ml/min
10. Bilirubin ≤ upper limit of normal, alanine aminotransferase ≤ 1.5 x upper limit of
normal and/or aspartate aminotransferase ≤ 1.5 x upper limit of normal, alkaline
phosphatase ≤ 2.5 x upper limit of normal
11. Prothrombin time (PT)/international normalized ratio (INR) ≤ 1.5 x upper limit of
12. Activated partial thromboplastin (aPTT) time ≤ 1.5 x upper limit of normal
13. Female patients must have a negative urine or serum pregnancy at screening (pregnancy
test is not required for patients with bilateral oophorectomy and/or hysterectomy or
for those patients who are > 1 year postmenopausal)
14. All patients of reproductive potential must agree to use a medically acceptable form
of contraception (eg, hormonal birth control, double-barrier method) or abstinence.
1. Prior history or current diagnosis of leukemia
2. Have received any gene therapy products or oncolytic viral therapy
3. Receiving allopurinol
4. Received an investigational drug within 30 days prior to first injection of Ad/PNP
5. Received radiation treatment < 4 weeks prior to first injection of Ad/PNP, and does
not have any RECIST 1.1 evaluable lesions that are outside the radiation field. (If
the patient has RECIST 1.1 evaluable lesions outside the radiation field then they can
6. Received chemotherapy (systemic anticancer treatment) < 4 weeks prior to first
injection of Ad/PNP and has not recovered from all the related side effects. (If the
patients has recovered from related side effects or has reached a new baseline then
can be included)
7. Has significant baseline neuropathy (> grade 2 based on CTCAE v4.0)
8. Uncontrolled intercurrent disease (e.g., diabetes, hypertension, thyroid disease,
9. Had within 6 months prior to enrollment: Myocardial infarction, cerebral vascular
accident, uncontrolled congestive heart failure, significant liver disease, unstable
10. Fever (temperature > 38.1 degrees C orally)
11. Receiving chronic systemic corticosteroids (> 3 weeks) or any chronic
immunosuppressive medications within 14 days prior to first injection of Ad/PNP.
Subjects receiving short courses of corticosteroids are considered eligible for the
12. Receiving anticoagulants other than those to maintain patency of venous lines
13. Women who are pregnant or breast feeding
14. History of HIV infection. No requirement for testing.
Ages Eligible for Study
18 Years - N/A
Genders Eligible for Study