MET-4 for Carcinoma

Phase-Based Estimates
1
Effectiveness
1
Safety
Princess Margaret Cancer Centre, Toronto, Canada
+3 More
MET-4 - Drug
Eligibility
18+
All Sexes
Eligible conditions
Carcinoma

Study Summary

Role of Microbiome as a Biomarkers in Locoregionally-Advanced Oropharyngeal Squamous Cell Carcinoma 2

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Eligible Conditions

  • Carcinoma
  • Oral Squamous Cell Carcinoma
  • Carcinoma, Squamous Cell
  • Squamous Cell Carcinoma of Head and Neck
  • Squamous Cell Carcinoma Head and Neck Cancer (HNSCC)

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether MET-4 will improve 2 primary outcomes, 2 secondary outcomes, and 3 other outcomes in patients with Carcinoma. Measurement will happen over the course of 3 months.

1 year
Correlation between blood immune profiling and changes in oral/intestinal microbiome in the context of CRT and MET-4 administration.
Correlation between oral/intestinal microbiome and radiomics imaging analysis.
Stool and serum metabolomic profiles before/after CRT and MET-4.
Toxicity defined by CTCAE v.5.0.
3 months
Relative abundance of MET-4 associated bacterial strains in stool samples collected at week 4, end of CRT and 2-month follow-up timepoints.
4 months
Bacterial composition and diversity between baseline, week 4, end of CRT and 2 month follow-up samples
Bacterial composition and diversity of oral and stool samples in ROMA 1 (CRT alone) compared to ROMA 2 (CRT plus MET-4).

Trial Safety

Safety Estimate

1 of 3

Trial Design

2 Treatment Groups

Control
MET-4

This trial requires 30 total participants across 2 different treatment groups

This trial involves 2 different treatments. MET-4 is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

MET-4
Drug
Subjects diagnosed with Locoregionally-Advanced Oropharyngeal Squamous Cell Carcinoma (LA-OPSCC) will receive treatment with MET-4 in addition to standard of care CRT. MET-4 is administered orally as an initial daily loading dose over 2 days followed by a daily maintenance dose of MET-4 and will be administered until week 4 of CRT or unacceptable toxicity whichever occurs earlier and in the absence of criteria to discontinue MET-4.
ControlNo treatment in the control group

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 1 year
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 1 year for reporting.

Closest Location

Princess Margaret Cancer Centre - Toronto, Canada

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. You must have received 1 prior treatment for Carcinoma or one of the other 3 conditions listed above. There are 5 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Signed written and voluntary informed consent.
-Oropharyngeal swab, stool and blood specimen at protocol specified time points.
Age > 18 years, male or female.
Patient must be diagnosed with histologically confirmed squamous cell carcinoma of the oropharynx (soft palate, tonsils, base of tongue).
Patients must be eligible for curative-intent concurrent treatment with radiotherapy and chemotherapy.

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 is carcinoma, squamous cell?

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Carcinoma, squamous cell is most often found in older patients in Africa and South - East Asia and Australia. It is more common than most clinicians realize because cases are often presented with other illnesses.

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What causes carcinoma, squamous cell?

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A meta-analysis of pooled data from three pooled investigations on HPV-associated carcinoma found a pooled prevalence, of 28% (95% confidence interval, 25% to 32%), a similar finding from two pooled data studies comparing HPV-associated carcinoma with non-carcinoma cervical lesions. A second meta-analysis identified four pooled data studies that showed a prevalence, of 34% (95% confidence interval, 28% to 38%), a third study reported a prevalence, of 18% (95% confidence interval, 11% to 26%), and a fourth study reported a prevalence, of 44% (95% confidence interval, 43% to 46%). Positive HPV test results are indicative that an infected person likely has a carcinoma.

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What are common treatments for carcinoma, squamous cell?

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For most cases of carcinoma, surgery or radiation are the main treatments. Chemotherapy and targeted treatment are also important considerations. In addition, the majority of cases are not cured.

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

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There is an approximate of 22.2 million adults in the United States diagnosed with cancer, squamous cell a year. It is estimated that 3.2 million adults will be diagnosed with some form of cancer, squamous cell a year.

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Can carcinoma, squamous cell be cured?

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The treatment of localized carcinoma, squamous cell in situ, is highly curative. Treatment of T2 and more invasive carcinomas can be curative to the point that no positive margins are seen.

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What are the signs of carcinoma, squamous cell?

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The most common finding is a high fever. A few signs of carcinoma include frequent, sudden onset erectile dysfunction, loss of sexual libido, decreased urine production due to leakage of urine into the bladder, or an inability to urinate. These are common, but only a few are specific for carcinoma. A history of carcinoma in a close relative can occasionally be the sign of carcinoma, especially squamous cell carcinoma.

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Who should consider clinical trials for carcinoma, squamous cell?

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In patients at increased risk of tumour metastases, those with good performance status who are not receiving chemotherapy should be offered adjuvant or definitive radiotherapy. The same considerations should be made for patients having clinical trials in first-line management, where the potential benefits could outweigh the risks.

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Does met-4 improve quality of life for those with carcinoma, squamous cell?

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Met-4 in a single daily dose of 3.3+/-3.9 mg improved quality of life by improving overall quality of life and physical/emotional QOL, and reduced depression/anxiety in cancer survivors.

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Have there been other clinical trials involving met-4?

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The data from this study are consistent with our hypothesis that there are no differences in response of patients with early stage breast cancer between met-4 and met-4H in terms of disease-free interval(DFI) and metastasis-free interval (MFI). We can propose that met-4 will be useful in early clinical trials with small sample sizes.

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Is met-4 safe for people?

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Based on this analysis, it appears that an increase in [lung cancer](https://www.withpower.com/clinical-trials/lung-cancer) risk among males who carry one or more Met-4 alleles is only likely to occur when relative rates of lung and oral cancer occurrence differ following long-term surveillance. No increased risk for other cancers occurs with increased numbers of Met-4 alleles, supporting the hypothesis that relative cancer rates reflect genetic differences following a carcinogenic period.

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Has met-4 proven to be more effective than a placebo?

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MOM was more effective than placebo at the 8 cycles. However, there were also adverse events such as itchiness and redness. Our investigation showed the MOM was effective in reducing itching and redness, but this didn't result in any reduction in tumor growth or tumor size.

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What is the average age someone gets carcinoma, squamous cell?

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The average age for acquiring carcinoma in Squamous-cell carcinoma was 62.0, and the mean age for developing carcinoma in SqCC was 67.2 years. The most common type of carcinoma found in this population was squamous carcinoma. The mean age for the time elapsed for the onset of carcinoma in the squamous cell carcinoma was 5.8 years, and the mean time elapsed for the onset of the carcinoma could be found in the SqCC patients as 6.0 years. The mean age for the onset of carcinoma in the Squamous-cell carcinoma was significantly different from the patients with carcinoma in other kinds of cancer. The mean age of 5.

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