Onalespib + Radiation Therapy + Cisplatin for Head and Neck Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine the optimal dose of a new drug, onalespib, when combined with radiation therapy and the chemotherapy drug cisplatin, for treating certain types of head and neck cancer. Onalespib blocks a protein that aids cancer cell growth, potentially enhancing the effectiveness of the other treatments. The trial targets individuals with squamous cell carcinoma in areas such as the mouth or throat, where the cancer has spread to nearby tissues or lymph nodes. It suits those who have not received prior treatment for this cancer and whose condition may be curable with these combined therapies. As a Phase 1 trial, this research focuses on understanding the treatment's effects in people, offering participants the chance to be among the first to receive this new drug.
Do I have to stop taking my current medications for the trial?
The trial protocol does not specify if you need to stop taking your current medications, but it does prohibit the use of all herbal supplements during the study. It's best to discuss your current medications with the trial team to ensure they are not prohibited.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that onalespib is generally easy for patients to handle. It is safer than similar drugs because it dissolves well in water. Patients who have used onalespib, even alongside other treatments, find it manageable.
Cisplatin, a common chemotherapy drug, reliably treats head and neck cancers with a strong safety profile. Studies indicate that using it weekly or every three weeks is both safe and effective, with no major safety differences between the schedules.
Intensity-modulated radiation therapy (IMRT) is also considered safe. It targets tumors more precisely, protecting healthy tissue and resulting in fewer side effects compared to older radiation methods.
Overall, past studies show that the treatments in this trial have a good safety record.12345Why are researchers excited about this trial's treatments?
Researchers are excited about the Onalespib treatment for head and neck cancer because it introduces a novel approach by targeting heat shock protein 90 (Hsp90), which plays a role in cancer cell survival and growth. Unlike traditional treatments like surgery, radiation, and chemotherapy alone, Onalespib works alongside cisplatin and radiation to potentially enhance their effectiveness. This combination aims to improve treatment outcomes by making cancer cells more sensitive to traditional therapies, which could lead to better control of the disease with potentially fewer side effects.
What evidence suggests that this trial's treatments could be effective for head and neck cancer?
In this trial, participants will receive a combination of onalespib, cisplatin, and intensity-modulated radiation therapy (IMRT). Research has shown that onalespib, a drug that blocks the protein HSP90, can slow or stop tumor growth, making cancer cells more sensitive to treatments like chemotherapy and radiation. Laboratory studies have found that onalespib works well with radiation and enhances the effect of cisplatin, a common chemotherapy drug, in killing cancer cells. Cisplatin is known for stopping tumor growth and has effectively treated head and neck cancers, with studies showing good control over time. IMRT is a precise form of radiation that targets tumors more accurately and causes less damage to healthy tissues, improving outcomes for patients with head and neck cancers. Together, these treatments show promise in effectively treating head and neck squamous cell carcinoma.23678
Who Is on the Research Team?
Andrew Hope, MD, FRCPC
Principal Investigator
University Health Network Princess Margaret Cancer Center LAO
Are You a Good Fit for This Trial?
This trial is for adults with advanced squamous cell carcinoma of the head and neck, without distant metastases. Participants must have a certain level of physical fitness (ECOG <=1), adequate organ function, no severe hearing loss or significant heart conditions, not be HIV-positive on antiretroviral therapy, and agree to use contraception. Those with other recent cancers or uncontrolled illnesses are excluded.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive onalespib, cisplatin, and IMRT. Onalespib is administered IV on days -7, 3, 10, 24, 31, and 38. Cisplatin is administered IV on days 1, 8, 15, 22, 29, 36, and 43. IMRT is administered once daily, 5 days a week over 7 weeks.
Follow-up
Participants are monitored for safety and effectiveness after treatment completion. Follow-up occurs every 3 months for 1 year, then every 6 months for another year, and potentially every 6 months for up to 3 additional years.
What Are the Treatments Tested in This Trial?
Interventions
- Cisplatin
- Intensity-Modulated Radiation Therapy
- Onalespib
Cisplatin is already approved in European Union, United States, Canada, Japan for the following indications:
- Testicular cancer
- Ovarian cancer
- Cervical cancer
- Bladder cancer
- Head and neck cancer
- Esophageal cancer
- Lung cancer
- Mesothelioma
- Brain tumors
- Neuroblastoma
- Testicular cancer
- Ovarian cancer
- Cervical cancer
- Bladder cancer
- Head and neck cancer
- Esophageal cancer
- Lung cancer
- Mesothelioma
- Brain tumors
- Neuroblastoma
- Testicular cancer
- Ovarian cancer
- Cervical cancer
- Bladder cancer
- Head and neck cancer
- Esophageal cancer
- Lung cancer
- Mesothelioma
- Brain tumors
- Neuroblastoma
- Testicular cancer
- Ovarian cancer
- Cervical cancer
- Bladder cancer
- Head and neck cancer
- Esophageal cancer
- Lung cancer
- Mesothelioma
- Brain tumors
- Neuroblastoma
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Cancer Institute (NCI)
Lead Sponsor