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Alkylating agents

Onalespib + Radiation Therapy + Cisplatin for Head and Neck Cancer

Phase 1

Waitlist Available

Led By Andrew J Hope

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Eastern Cooperative Oncology Group (ECOG) performance status =< 1 (Karnofsky >= 70%)

Patients must have a histologically or cytologically confirmed, previously untreated squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx

Must not have

History or evidence of current >= class II congestive heart failure as defined by the New York Heart Association (NYHA) functional classification system

HIV-positive patients on combination antiretroviral therapy are ineligible

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing onalespib + IMRT + cisplatin to see if it's more effective than just IMRT + cisplatin at treating squamous cell carcinoma of the head and neck.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects include reactions related to immune system suppression such as infection risk increase, possible damage to normal tissue from radiation therapy, kidney problems due to Cisplatin, fatigue from chemotherapy, and specific issues like nerve damage or heart complications.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am mostly active and can care for myself.

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I have a confirmed, untreated squamous cell carcinoma in my mouth or throat.

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My condition is potentially treatable with radiation and cisplatin chemotherapy.

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My tumor is in stages T1-4, N2b-3, M0 and may be HPV+ with high risk features or HPV-.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have moderate to severe heart failure.

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I am not HIV-positive or not on antiretroviral therapy.

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I have had radiation therapy for head or neck cancer.

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My cancer originates from the nasopharynx, paranasal sinus, skin, or is of unknown origin.

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I am not currently using any herbal supplements.

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I have a history of heart problems.

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I do not have severe numbness, pain, or weakness in my hands or feet.

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My cancer has spread to distant parts of my body.

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I do not have any serious illnesses or social situations that would stop me from following the study's requirements.

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My high blood pressure is not controlled by medication.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

PK profile of cisplatin in combination with concurrent onalespib and radiotherapy

Cisplatin

Secondary study objectives

Antitumor activity

Incidence of non-DLT adverse events (AEs)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (onalespib, cisplatin, IMRT)Experimental Treatment5 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cisplatin

2013

Completed Phase 3

~3120

Onalespib

2017

Completed Phase 1

~30