Bintrafusp Alfa and Stereotactic Body Radiation Therapy for the Treatment of Recurrent or Second Primary Head and Neck Squamous Cell Cancer

• Status: Recruiting
• Trial end date: 2021-08-31
• Target enrollment: 0
• Participant gender: All

Summary

This phase I/II trial studies the side effects and how well bintrafusp alfa and stereotactic body radiation therapy work in treating patients with head and neck squamous cell cancer that has come back (recurrent) or has occurred after having cancer in the past (second primary). Immunotherapy with bintrafusp alfa may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. Stereotactic body radiation therapy uses special equipment to position a patient and deliver radiation to tumors with high precision. This method can kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue. Giving bintrafusp alfa and stereotactic body radiation therapy may help to control recurrent head and neck squamous cell cancer.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: M.D. Anderson Cancer Center
• Collaborator: National Cancer Institute (NCI)
• Treatments: Atezolizumab

Criteria

Inclusion Criteria:

• Patients with histologically documented local-regional recurrent squamous cell carcinoma of the head and neck, or second primary squamous cell carcinoma of the head and neck

• Patients must be willing to undergo research biopsy for tissue collection at baseline and at disease progression

• Previous receipt of at least 30 Gy of radiation for head and neck squamous cell cancer (HNSCC) with overlapping fields

• Not eligible or poor candidate or patient refusal of surgery for recurrence

• Evaluable disease apparent on imaging (MRI or computed tomography [CT])

• 1 to 3 sites of recurrence (< 60 cm^3 per site, total volume < 100 cm^3)

• Eastern Cooperative Oncology Group (ECOG) = 0, 1, or 2

• White blood count (WBC) >= 2000/L

• Absolute neutrophil count (ANC) >= 1,500 cells/mm^3

• Platelets >= 100,000 cells/mm^3

• Hemoglobin >= 9.0 g/dl; Note: The use of transfusion or other intervention to achieve hemoglobin (Hgb) >= 9.0 g/dl is acceptable

• Serum creatinine =< 1.5 mg/dl or creatinine clearance (CC) >= 50 ml/min determined by 24-hour collection or estimated by Cockcroft-Gault formula

• Total bilirubin =< 1.5 x upper limit of normal (ULN) (except patients with Gilbert syndrome who can have total bilirubin < 3.0 mg/dL)

• Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) < 3 x the upper limit of normal

• Negative serum pregnancy test for women of childbearing potential and confirmation within 24 hours of first dose of study drug

Exclusion Criteria:

• Presence of distant metastases

• Less than six-month disease free interval from end of prior radiotherapy to the head and neck

• Prior receipt of anti-PD-1/L1

• Patients who are pregnant or breast feeding

• Clinically significant uncontrolled major cardiac, respiratory, renal, hepatic, gastrointestinal or hematologic disease but not limited to: symptomatic congestive heart failure, unstable angina, or cardiac dysrhythmia not controlled by pacer device; myocardial infarction within 3 months of registration

• Active autoimmune disorder or immunosuppression (including human immunodeficiency virus [HIV], but excluding endocrine abnormalities that are controlled with replacement medications)

• Active viral hepatitis

• Steroid therapy of greater than prednisone 10 mgs a day or equivalent

• Prior history of invasive non-head and neck cancer within two years, with the exception of screen detected prostate cancer treated with observation only, basal cell and squamous cell carcinoma of the skin, and micro-invasive resected cervical carcinoma