CompletedPhase 1

Onalespib in Treating Patients With Locoregionally Advanced Squamous Cell Carcinoma of the Head and Neck Receiving Radiation Therapy and Cisplatin

United States, Canada2 participantsStarted 2015-10-22

Plain-language summary

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.

Who can participate

Age range

18 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patients must have a histologically or cytologically confirmed, previously untreated squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx * Tumors must be staged T1-4, N2b-3, M0 (human papillomavirus positive \[HPV\]+ or HPV negative \[-\]); patients with HPV+ tumors should have at least one high risk feature such as T4, N3, or smoking history of \> 10 pack years * The disease must be considered to be potentially curable by combined radiotherapy and cisplatin based chemotherapy * Eastern Cooperative Oncology Group (ECOG) performance status =\< 1 (Karnofsky \>= 70%) * Life expectancy of greater than 6 months * Absolute neutrophil count (ANC) \>= 1.5 x 10\^9/L * Hemoglobin \>= 9 g/dL * Platelets \>= 100 x 10\^9/L * Serum creatinine =\< 1.5 mg/dL (=\< 120 umol/L) OR calculated creatinine clearance (Cockcroft-Gault formula) \>= 50 mL/min OR 24-hour urine creatinine clearance \>= 50 mL/min * Bilirubin =\< 1.5 x upper limit of normal (ULN) * Aspartate aminotransferase (AST) =\< 2.5 x ULN * Alanine aminotransferase (ALT) =\< 2.5 x ULN * Proteinuria =\< +1 on dipstick or =\< 1 gram/24 hours * Corrected QT using the Fridericia formula (QTcF) \< 470 msec * Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, during the study participation, and for three months after the last dose of the drug; women of child-bearing potential must …

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Maximum tolerated dose determined by dose-limiting toxicity (DLT) of onalespib in combination with concurrent cisplatin and radiation therapy graded according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0

Timeframe: 8 weeks

Pharmacokinetic (PK) profile of onalespib in combination with cisplatin and radiation therapy

Timeframe: Baseline, 0.5, 1, 2, 3, 4, 6, 8, 9, and 24 hours on day -7; baseline, 0.5, 1, 2, 3, 4, 6, 8, 9, 24 hours on day 9; and baseline on day 24

PK profile of cisplatin in combination with concurrent onalespib and radiotherapy

Timeframe: Baseline, at end of cisplatin infusion, at 2, 4, 6, and 8-9 on day 8, and 24 hours on day 9, and at baseline on days 22 and 29

Trial details

NCT IDNCT02381535

SponsorNational Cancer Institute (NCI)

Sponsor typeNIH

Study typeINTERVENTIONAL

Primary completion2020-04-24

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