Peposertib + Radiation for Advanced Head and Neck Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new treatment for advanced head and neck cancer. Researchers are testing a drug called peposertib combined with radiation to assess its safety and effectiveness for patients unable to use the common chemotherapy drug, cisplatin. Peposertib may inhibit cancer cell growth by blocking certain necessary enzymes. Individuals with metastatic head and neck cancer who cannot tolerate cisplatin might be suitable candidates for this study. As a Phase 1 trial, the research aims to understand how the treatment works in people, providing participants the opportunity to be among the first to receive this new treatment.
Do I need to stop my current medications for the trial?
Yes, you may need to stop certain medications. The trial excludes participants who cannot discontinue proton pump inhibitors 5 days before treatment and those taking strong inhibitors, inducers, or sensitive substrates of specific enzymes (CYP3A4/5, CYP2C19, CYP2C9, CYP1A2, CYP2B6) before the study. Opioids are allowed, except methadone.
Will I have to stop taking my current medications?
The trial requires participants to stop taking proton pump inhibitors 5 days before treatment and any medications that are strong inhibitors, inducers, or sensitive substrates of certain liver enzymes (CYP3A4/5, CYP2C19, CYP2C9) before starting the study. Opioids are allowed, except for methadone.
Is there any evidence suggesting that this treatment is likely to be safe for humans?
Research has shown mixed safety results when combining peposertib with radiation therapy. In one study, this combination was unsafe for some patients with head and neck cancer. However, another study found that peposertib, when used with palliative radiation therapy, was well-tolerated at doses up to 200 mg once a day. This indicates that some patients managed the treatment without serious issues at that dose. It is important to note that this treatment remains under investigation. The goal is to determine the optimal dose and assess its safety for a broader patient population.12345
Why do researchers think this study treatment might be promising?
Peposertib is unique because it targets the DNA damage response in cancer cells, potentially enhancing the effectiveness of radiation therapy. Unlike traditional treatments for advanced head and neck cancer, which often rely solely on radiation or chemotherapy, peposertib is taken orally before each radiation session. This approach aims to make cancer cells more sensitive to radiation, potentially improving outcomes and reducing the chance of disease progression. Researchers are excited about peposertib because it offers a novel way to attack cancer cells, possibly leading to better survival rates and fewer side effects.
What evidence suggests that peposertib combined with radiation therapy might be an effective treatment for advanced head and neck cancer?
Research has shown that peposertib, a treatment in this trial, can effectively slow tumor growth when combined with radiation therapy. In studies with mice, this combination stopped tumor growth in various cancers, including head and neck cancer. Peposertib blocks an enzyme that tumor cells need to grow, enhancing the effectiveness of radiation in killing these cells. Although still in the early stages, this research suggests that the treatment could be promising for individuals with advanced head and neck cancer.23678
Who Is on the Research Team?
Maura L Gillison
Principal Investigator
NRG Oncology
Are You a Good Fit for This Trial?
This trial is for adults with advanced head and neck cancer who can't take cisplatin. Participants must be HIV-positive on effective treatment, able to swallow tablets, willing to use contraception, have certain types of oropharynx cancer stages, measurable disease per RECIST 1.1 criteria, specific blood cell counts within range, and no history of distant metastatic disease.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive peposertib orally once daily and undergo IMRT daily Monday-Friday for 7 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Peposertib
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Cancer Institute (NCI)
Lead Sponsor
NRG Oncology
Collaborator