Ignite Creation Date:
2025-12-25 @ 1:38 AM
Ignite Modification Date:
2025-12-31 @ 5:27 PM
Study NCT ID:
NCT06997094
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-10-27
First Post:
2025-05-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Decitabine in Combination With Standard of Care Therapy for the Treatment of Surgically Resectable HPV-Negative Head and Neck Cancer
Sponsor:
Mayo Clinic
Organization:
Study Overview
Official Title:
Phase I Decitabine Dose-Tolerance in Surgically Resectable HPV-Negative Head and Neck Cancer
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This phase I trial tests the safety, side effects, and best dose of decitabine in combination with standard of care surgery, radiation, and/or chemotherapy and the effectiveness of the combination in treating patients with head and neck squamous cell cancers that are not caused by human papilloma virus (HPV-negative) and that can be removed by surgery (resectable). Decitabine, an antimetabolite, stops cells from making deoxyribonucleic acid (DNA) and may kill tumor cells. Studies have shown that medications like decitabine can make some types of solid tumors more sensitive to chemotherapy. This allows the chemotherapy to be more effective, with slower progression and longer survival. Decitabine is also a clinically active demethylating agent, and may help make tumor cells more sensitive to radiation therapy. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill tumor cells and shrink tumors. External beam radiation therapy (EBRT) is a type of radiation that uses a machine to aim high-energy rays at the tumor from outside the body. Chemotherapy drugs work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving decitabine in combination with standard of care surgery, radiation and/or chemotherapy may be safe, tolerable, and/or effective in treating patients with surgically resectable HPV-negative head and neck squamous cell cancers.
Detailed Description:
PRIMARY OBJECTIVE:
I. To prospectively evaluate maximum tolerated dose of decitabine with standard-of-care therapy surgery and/or radiation/chemotherapy for HPV-negative head and neck cancers.
SECONDARY OBJECTIVES:
I. 1-year overall survival. (Stratified by methylation status) II. 1-year progression free survival. (Stratified by methylation status) III. Acute/late Common Terminology Criteria for Adverse Events (CTCAE) toxicity. (Stratified by methylation status)
CORRELATIVE RESEARCH OBJECTIVES:
I. In vivo methylation response to preoperative decitabine. II. Pharmacokinetics of decitabine. III. Exploratory circulating biomarkers.
OUTLINE: This is a dose-escalation study followed by a dose-expansion study.
PREOPERATIVE PHASE: Patients receive decitabine intravenously (IV) over 1 hour once daily (QD) for 3 days and undergo standard of care surgery within 28 days of receiving decitabine.
ADJUVANT TREATMENT: Patients receive decitabine IV over 1 hour QD for 3 days every 3 weeks during radiation therapy in the absence of disease progression or unacceptable toxicity. Patients also undergo EBRT QD on 5 days per week for up to 5-35 treatments per standard of care. Patients may receive concurrent chemotherapy of choice per standard of care.
Patients also undergo blood sample collection throughout the study.
After completion of study treatment, patients are followed up at 30 days, every 4-6 months for 2 years and then every 12 months for up to 5 years.
I. To prospectively evaluate maximum tolerated dose of decitabine with standard-of-care therapy surgery and/or radiation/chemotherapy for HPV-negative head and neck cancers.
SECONDARY OBJECTIVES:
I. 1-year overall survival. (Stratified by methylation status) II. 1-year progression free survival. (Stratified by methylation status) III. Acute/late Common Terminology Criteria for Adverse Events (CTCAE) toxicity. (Stratified by methylation status)
CORRELATIVE RESEARCH OBJECTIVES:
I. In vivo methylation response to preoperative decitabine. II. Pharmacokinetics of decitabine. III. Exploratory circulating biomarkers.
OUTLINE: This is a dose-escalation study followed by a dose-expansion study.
PREOPERATIVE PHASE: Patients receive decitabine intravenously (IV) over 1 hour once daily (QD) for 3 days and undergo standard of care surgery within 28 days of receiving decitabine.
ADJUVANT TREATMENT: Patients receive decitabine IV over 1 hour QD for 3 days every 3 weeks during radiation therapy in the absence of disease progression or unacceptable toxicity. Patients also undergo EBRT QD on 5 days per week for up to 5-35 treatments per standard of care. Patients may receive concurrent chemotherapy of choice per standard of care.
Patients also undergo blood sample collection throughout the study.
After completion of study treatment, patients are followed up at 30 days, every 4-6 months for 2 years and then every 12 months for up to 5 years.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: