Phase II Trial of Neoadjuvant Chemotherapy (NAC) Alone or in Combination With Immunotherapy Vaccine PRGN-2009 in Subjects With Newly Diagnosed HPV-Associated Oropharyngeal (Head and Neck) Cancer
National Cancer Institute (NCI)
Summary
Background: Throat cancer is a common tumor that can occur in people infected with the human papilloma virus (HPV). Most people with this cancer survive more than 5 years with standard chemotherapy drugs plus radiation. But radiation can cause serious adverse effects. Researchers believe that adding a vaccine (PRGN-2009) to this drug therapy may improve survival without the need for radiation. Objective: To test a study vaccine combined with standard chemotherapy in patients with HPV-associated throat cancers. Eligibility: People aged 18 years and older with newly diagnosed throat cancer associated with HPV. Design: Participants will be screened. They will have a physical exam and blood tests. They will have imaging scans and tests of their heart function and hearing. They will provide a sample of tissue from their tumor. A recent sample may be used; if none is available, a new sample will be taken. All participants will get two common drugs for treating cancer. These drugs are given through a tube attached to a needle inserted into a vein in the arm. Participants will receive these drugs on the first day of three 3-week cycles. Half of the participants will also get the vaccine. PRGN-2009 is injected under the skin in the arm. They will get these shots 4 times: 7 days before the start of the first cycle and on the 11th day of each cycle. Participants will have standard surgery to remove their tumors 3 to 6 weeks after completing the study treatment. They will have follow-up visits 3, 6, 12, and 24 months after their surgery. ...
Description
Background: * Human papilloma virus (HPV)-associated oropharyngeal squamous cell carcinoma (OPSCC) is among the most common HPV-associated malignancies and the incidence is increasing. The prognosis is favorable with \>80% 5-year recurrence free survival observed following standard anti-cancer treatments that consist of surgery followed by adjuvant post-operative radiation therapy (PORT) or concurrent chemoradiation (CRT). * Although oncologic control is excellent, these standard-of-care treatments often lead to radiation-associated long-term toxicity that includes tissue fibrosis resulting i…
Eligibility
- Age range
- 18–120 years
- Sex
- All
- Healthy volunteers
- No
* INCLUSION CRITERIA: * Histologically or cytologically confirmed surgically resectable newly diagnosed stage I (cT1-2, N0-1) or II (T1-3, N0-2), M0 oropharyngeal squamous cell carcinoma. Note: Pathological report of cancer diagnosis may be from the primary tumor or from a metastatic cervical lymph node. * History of HPV-positive status determined by a standard-of-care HPV testing. Note: All participants with high-risk HPV serotypes are eligible. * Age \>= 18 years. * ECOG performance status \<= 2. * Individuals who smoke currently must smoke \<10 pack years. Note: Former smokers with any pack…
Interventions
- DrugDocetaxel
Docetaxel 75 mg/m\^2 will be administered over 60 (+/-10) minutes.
- DrugCisplatin
Cisplatin 75 mg/m\^2 will be administered over 120 (+/-10) minutes.
- DrugPRGN-2009
PRGN-2009 will be administered in Arm 2 participants only as an SQ injection in the arm at a dose of 1 mL nominally containing 5x10\^11 viral particles (VP) on Day -7 (+/-3 days) of Cycle 1, Day 11 (+/-3 days) of Cycles 1, 2, and 3.
Location
- National Institutes of Health Clinical CenterBethesda, Maryland