Decitabine + Standard Therapy for Head and Neck Cancer

CT
Overseen ByClinical Trials Referral Office
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the effectiveness of combining the drug decitabine with standard treatments such as surgery, radiation, and chemotherapy for certain types of head and neck cancer. The focus is on cancers not linked to HPV, which can be surgically removed and may respond better to treatment with decitabine. Participants with HPV-negative head and neck cancer that can be surgically removed might be suitable candidates. The trial primarily assesses the safety and effectiveness of this combined approach. As a Phase 1 trial, the research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor to understand how your medications might interact with the trial treatments.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research has shown that decitabine has undergone testing in various studies for safety. One study found that the most common side effect was a drop in blood cell counts. Another study reported side effects such as a low white blood cell count, nausea, and high levels of fat in the blood. Despite these side effects, decitabine has been used in cancer treatments and is generally considered manageable. Additionally, health authorities have already approved decitabine for certain conditions, suggesting its recognized safety. However, this trial is in an early phase, focusing on assessing safety and determining the right dose. More data is being collected to fully understand its tolerance in this specific use.12345

Why do researchers think this study treatment might be promising for head and neck cancer?

Unlike the standard treatments for head and neck cancer, which typically involve surgery, radiation, and chemotherapy, Decitabine offers a unique approach. Researchers are excited about Decitabine because it acts as a DNA hypomethylating agent, potentially reactivating genes that suppress tumors. This mechanism could enhance the effectiveness of traditional therapies by making cancer cells more sensitive to treatment. Additionally, Decitabine is administered intravenously over a short period, which might lead to faster results compared to conventional chemotherapy. This innovative approach provides hope for improved outcomes in head and neck cancer treatment.

What evidence suggests that decitabine combined with standard therapy might be an effective treatment for head and neck cancer?

Research has shown that decitabine, which participants in this trial will receive, may increase tumor cells' sensitivity to treatments like chemotherapy and radiation. Studies have found that combining decitabine with chemotherapy can enhance the responsiveness of head and neck cancer to drugs like cisplatin. Specifically, one study discovered that decitabine improved the response of head and neck cancer cells to cisplatin. Additionally, decitabine can alter cancer cell growth and spread, making them easier to target and kill with standard treatments. These early findings suggest that adding decitabine to traditional treatments could improve outcomes for patients with this type of cancer.13678

Who Is on the Research Team?

AL

Adam L. Holtzman, MD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

This trial is for adults with HPV-negative head and neck squamous cell cancers that can be surgically removed. Participants must have certain blood counts within normal ranges, no distant metastases, and an ECOG performance status of 0 or 1. They should not have had chemotherapy in the last 5 years for other conditions, be pregnant or nursing, HIV positive on antiretroviral therapy, or have any severe diseases that could interfere with the study.

Inclusion Criteria

Alanine aminotransferase (ALT) and aspartate transaminase (AST) ≤ 3 x ULN (≤ 5 x ULN for patients with liver involvement) (obtained ≤ 14 days prior to registration)
Hemoglobin ≤ 9.0 g/dL (obtained ≤ 14 days prior to registration)
Platelet count ≥ 100,000/mm^3 (obtained ≤ 14 days prior to registration)
See 14 more

Exclusion Criteria

Nursing women
I had chemotherapy for a different condition within the last 5 years.
I am not on any experimental drugs for my cancer.
See 11 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Preoperative

Patients receive decitabine intravenously over 1 hour once daily for 3 days and undergo standard of care surgery within 28 days of receiving decitabine

4 weeks

Adjuvant Treatment

Patients receive decitabine IV over 1 hour once daily for 3 days every 3 weeks during radiation therapy. Patients also undergo EBRT daily on 5 days per week for up to 5-35 treatments per standard of care. Concurrent chemotherapy may be administered per standard of care

Up to 15 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 5 years
Follow-up at 30 days, every 4-6 months for 2 years, then every 12 months

What Are the Treatments Tested in This Trial?

Interventions

  • Chemotherapy
  • Decitabine
  • External Beam Radiation Therapy
  • Surgical Procedure
Trial Overview The trial tests decitabine combined with standard care (surgery, radiation/chemotherapy) to see if it's safe and effective against resectable HPV-negative head and neck cancers. Decitabine may make tumor cells more sensitive to treatment by stopping DNA production. The effectiveness of this combination will also be evaluated through questionnaires and biospecimen collection.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Treatment (decitabine, surgery, radiation)Experimental Treatment6 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials
3,427
Recruited
3,221,000+

Citations

Decitabine and Nivolumab in Participants With Recurrent ...This research study is for people who have recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) that has been confirmed by tissue or cell ...
5-Aza-2′-deoxycytidin (Decitabine) increases cancer-testis ...5-Aza-2′-deoxycytidin (Decitabine) increases cancer-testis antigen expression in head and neck squamous cell carcinoma and modifies immune checkpoint ...
Decitabine Rescues Cisplatin Resistance in Head and Neck ...The study provides direct evidence that decitabine restores cisplatin sensitivity in in vitro and in vivo models of HNSCC. Combination treatment of cisplatin ...
Research progress of decitabine in the treatment of solid ...In a meta-analysis conducted by Miriam et al., decitabine monotherapy resulted in a reported response rate of 40% [95% CI, 32–48%] in AML, with a median overall ...
Demethylation Therapy as a Targeted Treatment for Human ...Improved survival of patients with human papillomavirus-positive head and neck squamous cell carcinoma in a prospective clinical trial . J Natl Cancer Inst.
An update on the safety and efficacy of decitabine ...Data collected from this study demonstrated a median survival of 19.4 months by the closure of the study. The most common reported side effect was cytopenias.
Safety and efficacy of chidamide in combination with ...The most common adverse events were leukocytopenia (58%; grade 3: 16%), nausea (53%) and hypertriglyceridemia (26%). No immune-related adverse ...
Clinical Trial: NCT03019003This is a non-randomized, open-label, Phase IbI study to assess the safety and efficacy of oral decitabine (ASTX727) and durvalumab ...
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