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Safety and Efficacy of Repeat Administration of Ad/PNP and Fludarabine Phosphate in Patients With Local Head/Neck Cancer
Recruiting
I'm InterestedTrial ID: NCT03754933,
Purpose
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.
Official Title
Phase 1/2, Open-label Study Evaluating Safety of Repeat Administration of Ad/PNP-F-araAMP (Ad/PNP Administered Intratumorally Followed by Intravenous Fludarabine Phosphate) in Subjects With Recurrent, Local Head and Neck Cancer
Stanford Investigator(s)
A. Dimitrios Colevas, MD
Professor of Medicine (Oncology) and, by courtesy, of Otolaryngology - Head & Neck Surgery (OHNS) and of Radiation Oncology (Radiation Therapy)
Eligibility
Inclusion Criteria:
1. Provided Informed Consent
2. Age ≥ 18 years
3. 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.
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) measurable by Response Evaluation
Criteria in Solid Tumors (RECIST) 1.1 and technically suitable for intratumoral
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 intratumoral
injection accessible tumor(s) that are not accessible for intratumoral injection are
eligible ONLY if the patient has no other 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
administration.
8. Absolute neutrophil count ≥ 1,500 cells/ul; hemoglobin ≥ 9 g/dl, platelets ≥
100,000/ul
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
normal
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.
Exclusion Criteria:
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
be included.)
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
patient has recovered from all related side effects or has reached a new baseline,
then they may begin receiving treatment at sooner than 4 weeks)
7. Have significant baseline neuropathy (> Grade 2 based on Common Terminology Criteria
for Adverse events [CTCAE] v5.0)
8. Uncontrolled intercurrent disease (e.g., diabetes, hypertension, thyroid disease,
active infection)
9. Had within 6 months prior to enrollment: Myocardial infarction, cerebral vascular
accident, uncontrolled congestive heart failure, significant liver disease, unstable
angina
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
study.
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.
Intervention(s):
biological: Ad/PNP
drug: Fludarabine Phosphate
Recruiting
I'm InterestedContact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Head and Neck Team
secure-headandneckresearch@lists.stanford.edu