CLINICAL TRIAL

Vorinostat for Oral Squamous Cell Carcinoma

1 Prior Treatment
Metastatic
Recurrent
Waitlist Available · 18+ · All Sexes · Seattle, WA

This study is evaluating whether a combination of pembrolizumab and vorinostat is safe and effective in treating patients with head and neck cancer or salivary gland cancer.

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About the trial for Oral Squamous Cell Carcinoma

Eligible Conditions
Stage III Major Salivary Gland Carcinoma · Stage IVA Nasal Cavity and Paranasal Sinus Squamous Cell Carcinoma · Squamous Cell Carcinoma Head and Neck Cancer (HNSCC) · Carcinoma, Squamous Cell · Head and Neck Neoplasms · Recurrent Nasal Cavity and Paranasal Sinus Squamous Cell Carcinoma · Stage IVB Major Salivary Gland Carcinoma · Recurrent Nasopharynx Carcinoma · Carcinoma · Stage III Nasal Cavity and Paranasal Sinus Squamous Cell Carcinoma · Stage III Nasopharyngeal Carcinoma · Stage IV Nasopharyngeal Carcinoma · Stage IVB Nasal Cavity and Paranasal Sinus Squamous Cell Carcinoma · Stage IVC Major Salivary Gland Carcinoma · Squamous Cell Carcinoma Metastatic in the Neck With Occult Primary · Stage IVC Nasal Cavity and Paranasal Sinus Squamous Cell Carcinoma · Squamous Cell Carcinoma of Head and Neck · Recurrent Salivary Gland Carcinoma · Salivary Gland Neoplasms · Nasopharyngeal Carcinoma · Stage IVA Major Salivary Gland Carcinoma

Treatment Groups

This trial involves 2 different treatments. Vorinostat is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 1 & 2 and have already been tested with other people.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Laboratory Biomarker Analysis
OTHER
Vorinostat
DRUG
Pembrolizumab
BIOLOGICAL
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Vorinostat
FDA approved
Pembrolizumab
FDA approved

Eligibility

This trial is for patients born any sex aged 18 and older. You must have received 1 prior treatment for Oral Squamous Cell Carcinoma or one of the other 20 conditions listed above. There are 10 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Phase I run in: biopsy proven RMHNSCC with the following primary sites: nasopharynx, paranasal sinus, nasal cavity, skin/cutaneous sites; patients with unknown head and neck primary sites will be enrolled; patients with recurrent or metastatic squamous cell carcinomas of the head and neck (regardless of primary site) who are either unwilling to receive or have contraindications (deemed by treating physician) to standard systemic chemotherapy will also be eligible; patients with biopsy proven RMSGC be eligible as well
Phase II expansion: biopsy proven RMHNSCC, of any primary site (including unknown primary) and RMSGC will be eligible
Have evidence of disease progression by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria within 3 months prior to study enrollment; if the patient was receiving a prior line of systemic therapy, he/she should have evidence of disease progression on that line of treatment prior to enrollment
Have received any number lines of prior systemic therapy (including systemic therapy in the curative intent setting)
Be willing and able to provide written informed consent for the trial and comply with the study visit requirements
Have measurable disease based on RECIST 1.1
Have provided tissue from an archival tissue sample or newly obtained core or excisional biopsy of a tumor lesion
Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) performance scale
Absolute neutrophil count (ANC) >= 1,500/mcL
Platelets >= 100,000/mcL
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial

Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Up to 2 years
Screening: ~3 weeks
Treatment: Varies
Reporting: Up to 2 years
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Up to 2 years.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Vorinostat will improve 1 primary outcome and 3 secondary outcomes in patients with Oral Squamous Cell Carcinoma. Measurement will happen over the course of Up to 30 days after the completion of study treatment.

Incidence of Toxicity Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
UP TO 30 DAYS AFTER THE COMPLETION OF STUDY TREATMENT
Toxicities will be summarized as the number and percentage of patients with each type of toxicity, per Criteria for Adverse Events version 4.0
UP TO 30 DAYS AFTER THE COMPLETION OF STUDY TREATMENT
Overall Survival
UP TO 2 YEARS
The Kaplan Meier methods will be used to estimate overall survival.
UP TO 2 YEARS
Objective Response Rate
UP TO 2 YEARS
Radiologic assessments of measurable disease will be performed using radiographic imaging. RECIST 1.1 and immune response criteria will be used to assess response to therapy. Responses will be summarized as frequencies and percentages.
UP TO 2 YEARS
Progression Free Survival
UP TO 2 YEARS
The Kaplan Meier methods will be used to estimate progression free survival.
UP TO 2 YEARS

Patient Q & A Section

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

What causes oral squamous cell carcinoma?

Overall there is no clearly defined cause. A combination of various causes is likely to play a role in the development of OSCC. Tobacco smoking appears to be the predominant risk factor. Alcohol consumption is another major risk which can accelerate the process of carcinogenesis. Immunologic factors may also be involved.

Anonymous Patient Answer

Can oral squamous cell carcinoma be cured?

Recent findings indicate that there is a high risk of recurrence after an R1 resection of oral squamous cell carcinoma, which may necessitate adjuvant treatments for disease control.

Anonymous Patient Answer

What is oral squamous cell carcinoma?

In the United States, OSCC is estimated to affect 7,000 - 10,000 of the 18,000 adult cancer deaths each year. The overall 5-year survival rate after treatment for OSCC is about 55%, depending on disease stage. Most patients who develop OSCC are 60 to 64 years of age. Males and females are affected about equally. It tends to affect the more proximally placed teeth and the labial-buccal pole of the tongue. The most common sites for OSCC occurrence are the vermilion border of the tongue and the floor of the mouth. The primary cause of OSCC is cigarette smoking, but about one quarter of all patients with the disease have no current history of smoking.

Anonymous Patient Answer

What are common treatments for oral squamous cell carcinoma?

There is no effective and curative treatment for oral squamous cell carcinoma. Local treatment using radiation and chemotherapy is usually effective, and treatment intensification has not proven to be successful. Radiation is the best option for tumours of tongue and hard palate, while elective irradiation (without treatment intensification) is recommended for all patients with soft tissues tumors and head and neck carcinoma.

Anonymous Patient Answer

How many people get oral squamous cell carcinoma a year in the United States?

Based on these figures and data from other studies, it is estimated that about 3.4 million new cases of OSCC will occur in the US in 2010. The high rates of OSCC warrant greater efforts in public education and screening, and improved surveillance of OSCC and the development of a national prevention program. The prevention of OSCC may be improved by expanding the National Health Insurance coverage of oral cancer screening examinations, increased public education of the signs and symptoms of OSCC, intensified screening programs by dental professionals, and the early diagnosis and effective treatment of oral cancer.

Anonymous Patient Answer

What are the signs of oral squamous cell carcinoma?

Pain, swelling and loss of oral mobility may be some of the signs of oral cancer. Patients may be unaware of these signs unless questioned by their physician. Some signs of oral cancer are also evident when the patient looks for signs and symptoms of oral cancer. Patients with oral cancer may complain of pain or swelling at the opening of the mouth (the mouth opening) or on the outside of the lip. Most often, the site of the lesion is the base of the tongue or the floor of the mouth. The lips may have a rash or ulceration, and the inside of the lips may be tender. Rarely, cancer might be present in the mouth without symptoms.

Anonymous Patient Answer

What are the chances of developing oral squamous cell carcinoma?

The chance of OSCC development increases with time elapsed between first exposure and presentation. The development of more advanced histologies, such as grade IV, correlates with increasing age.

Anonymous Patient Answer

How serious can oral squamous cell carcinoma be?

We used the U.S. Preventive Services Task Force definition of a serious side effect. Oral cancer is rare for most people; if one has ever had head and neck cancer, one is already at risk.

Anonymous Patient Answer

What is vorinostat?

Vorinostat is a novel orally bioavailable HDACI with a distinct mechanism of action. The therapeutic index of vorinostat suggests that this agent has the potential to provide complete tumor control in patients treated at high-doses, when used at carefully defined time points.

Anonymous Patient Answer

How does vorinostat work?

Vorinostat alters gene mRNA expression and, in some cases, changes protein synthesis, in a manner consistent with disruption of the regulation of gene transcription by histone modifications. This drug, similar to HDAC inhibitors such as panobinostat, may be useful in treating epithelial tumors.

Anonymous Patient Answer

Does vorinostat improve quality of life for those with oral squamous cell carcinoma?

Vorinostat does not seem to be impacting people's quality of life over time in terms of fatigue or weight maintenance. There is a lack of evidence that vorinostat increases life expectancy in the short term in those with oral squamous cell carcinoma. This is the first study to report results of a direct comparative health status comparison between sorafenib and vorinostat in this setting.

Anonymous Patient Answer

What is the latest research for oral squamous cell carcinoma?

Although several reviews have described the importance of HPV (particularly HPV-16) in the etiology of oropharyngeal cancer, a large body of evidence continues to support a predominant role of a p16-dependent mechanism in oropharyngeal malignant transformation. However, HPV-induced cancer biology is relatively recent and may relate to the acquisition of other properties by this virus in oropharyngeal cancerous lesions. Understanding the unique molecular biology of these lesions, and consequently the relevance of different cellular pathways for oncogenesis, is an active area of active research.

Anonymous Patient Answer
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