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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights

Study 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.Check my eligibility
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.See study design
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-.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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
PK profile of cisplatin in combination with concurrent onalespib and radiotherapy
Cisplatin
Secondary outcome measures
Antitumor activity
Incidence of non-DLT adverse events (AEs)
Predictive biomarkers for individual cancer patients utilizing biopsies and genomic sequencing technologies

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
~1940
Onalespib
2017
Completed Phase 1
~30
Intensity-Modulated Radiation Therapy
2010
Completed Phase 3
~2160

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,660 Previous Clinical Trials
40,924,641 Total Patients Enrolled
Andrew J HopePrincipal InvestigatorUniversity Health Network Princess Margaret Cancer Center LAO

Media Library

Cisplatin (Alkylating agents) Clinical Trial Eligibility Overview. Trial Name: NCT02381535 — Phase 1
Squamous Cell Carcinoma Research Study Groups: Treatment (onalespib, cisplatin, IMRT)
Squamous Cell Carcinoma Clinical Trial 2023: Cisplatin Highlights & Side Effects. Trial Name: NCT02381535 — Phase 1
Cisplatin (Alkylating agents) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02381535 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the Onalespib drug been officially sanctioned by the Food and Drug Administration?

"Taking into account its phase 1 status, which implies limited evidence of safety and efficacy, our team at Power gave onalespib a score of 1."

Answered by AI

Are there any criteria that would exclude me from participating in this clinical experiment?

"Those wishing to qualify for this clinical trial must have laryngeal squamous cell carcinoma and be between 18-70 years old. Currently, the medical study is looking for 2 participants in total."

Answered by AI

Are participants aged 35 and over eligible for this medical research?

"As detailed in the selection requirements, individuals who wish to take part must be aged 18 or above and not older than 70."

Answered by AI

Are there any reports of prior experiments with Onalespib?

"Since 1997, when the first clinical trial of Onalespib was conducted at City of Hope Comprehensive Cancer Center, 1559 trials have come to completion. Currently there are 750 trials actively running; many taking place in New Haven, Connecticut."

Answered by AI

Are there any vacancies within this research protocol for more participants?

"Regrettably, this trial is closed and no longer seeking participants. It was first published on September 21st 2015 with the latest update being November 16th 2022. However, there are currently 2676 active trials for laryngeal squamous cell carcinoma patients and 750 studies actively recruiting those taking Onalespib."

Answered by AI

What is the enrollment quota for this research program?

"At present, this trial has ceased recruitment. It was initially posted on September 21st 2015 and the last update occured November 16th 2022. However, there are currently 2676 studies actively recruiting participants with laryngeal squamous cell carcinoma and 750 trials for Onalespib that are still enrolling patients."

Answered by AI

What diseases does Onalespib generally target?

"Onalespib is a common treatment for advanced ovarian cancer and can be beneficial to those with conditions that are unresponsive to conventional therapies, metastatic neoplasms, or advance directives."

Answered by AI
~0 spots leftby Apr 2025