Onalespib + Radiation Therapy + Cisplatin for Head and Neck Cancer

Recruiting at 1 trial location

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: National Cancer Institute (NCI)

Must not be taking: Herbal supplements, Antivirals

Disqualifiers: Metastases, Hearing impairment, Cardiovascular, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 35

Duration: 7 weeks

2 Participants Needed

Trial Summary

What is the purpose of this trial?

This phase I trial studies the side effects and best dose of onalespib when given together with intensity-modulated radiation therapy (IMRT) and cisplatin in treating patients with squamous cell carcinoma of the head and neck that has spread from where it started to nearby tissue or lymph nodes. Onalespib works by blocking a protein called HSP90. HSP90 helps protect cells from stress and supports many other proteins that cause cell growth. When HSP90 is blocked, tumor cell growth may be slowed or stopped and may die more easily when treated with chemotherapy and radiation. Drugs used in chemotherapy, such as cisplatin, 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. IMRT is a specialized radiation therapy that delivers beams of radiation of different intensities aimed at the tumor from many angles and may kill more tumor cells and cause less damage to normal tissue. Giving onalespib with cisplatin and IMRT may kill more tumor cells.

Research Team

Andrew Hope, MD, FRCPC

Principal Investigator

University Health Network Princess Margaret Cancer Center LAO

Eligibility Criteria

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

Life expectancy of greater than 6 months

Hemoglobin >= 9 g/dL

Platelets >= 100 x 10^9/L

Exclusion Criteria

I have or am at risk for serious eye problems like retinal detachment or macular degeneration.

I have moderate to severe heart failure.

I have hepatitis B or C, or HIV with a CD4 count of 500 or more and am not on antiviral agents.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

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.

7 weeks

35 visits (in-person for IMRT), multiple visits for IV administration

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.

Up to 5 years

Treatment Details

Interventions

• Cisplatin
• Intensity-Modulated Radiation Therapy
• Onalespib

Trial Overview The trial tests Onalespib combined with IMRT and Cisplatin in patients with locoregionally advanced head and neck cancer. It aims to find the best dose of Onalespib that's safe when used alongside standard treatments by seeing how it affects tumor growth when HSP90 protein is blocked.

Participant Groups

Group I: Treatment (onalespib, cisplatin, IMRT) Experimental Treatment 5 Interventions

Patient receive onalespib IV over 1 hour on days -7, 3, 10, 24, 31, and 38 and cisplatin IV over 1 hour on days 1, 8, 15, 22, 29, 36 and 43. Patients also undergo IMRT QD, 5 days a week over 7 weeks for a total of 35 fractions. Treatment continues in the absence of disease progression or unacceptable toxicity.

Cisplatin is already approved in European Union, United States, Canada, Japan for the following indications:

Approved in European Union as Platinol for:

• Testicular cancer
• Ovarian cancer
• Cervical cancer
• Bladder cancer
• Head and neck cancer
• Esophageal cancer
• Lung cancer
• Mesothelioma
• Brain tumors
• Neuroblastoma

Approved in United States as Platinol for:

• Testicular cancer
• Ovarian cancer
• Cervical cancer
• Bladder cancer
• Head and neck cancer
• Esophageal cancer
• Lung cancer
• Mesothelioma
• Brain tumors
• Neuroblastoma

Approved in Canada as Platinol for:

• Testicular cancer
• Ovarian cancer
• Cervical cancer
• Bladder cancer
• Head and neck cancer
• Esophageal cancer
• Lung cancer
• Mesothelioma
• Brain tumors
• Neuroblastoma

Approved in Japan as Platinol for:

• Testicular cancer
• Ovarian cancer
• Cervical cancer
• Bladder cancer
• Head and neck cancer
• Esophageal cancer
• Lung cancer
• Mesothelioma
• Brain tumors
• Neuroblastoma

Who Is Running the Clinical Trial?

National Cancer Institute (NCI)

Lead Sponsor

Trials

14,080

Recruited

41,180,000+