CLINICAL TRIAL

Selenomethionine (SLM) for Carcinoma

1 Prior Treatment
Locally Advanced
Metastatic
Recruiting · 18+ · All Sexes · Iowa City, IA

SLM + Axitinib for Clear Cell RCC

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About the trial for Carcinoma

Eligible Conditions
Carcinoma · Advanced Metastatic Clear Cell Renal Cell Carcinoma (CCRCC) · Carcinoma, Renal Cell

Treatment Groups

This trial involves 2 different treatments. Selenomethionine (SLM) 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.
Axitinib
DRUG
Selenomethionine (SLM)
DRUG
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
Axitinib
FDA approved

Eligibility

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 2 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:
At least one Response Evaluation Criteria In Solid Tumors (RECIST)-defined target lesion. *Patient must have documented disease progression.
Renal function (creatinine level within normal institutional limit, or creatinine clearance >15 mL/min/1.73 m2 for patients with creatinine levels above institutional normal, calculated using the Cockcroft-Gault formula).
Liver function (AST/ALT <2.5 X institutional upper limit of normal OR < 5 x institutional upper limit of normal in cases of liver metastases; Total bilirubin ≤ 1.5 times ULN.)
Adequate hematological lab values including;
Absolute Neutrophil Count (ANC) ≥ 1.0 x 109/L
Platelets ≥ 100 x 109/L
Hemoglobin ≥ 7.0 g/dL
Eastern Cooperative Oncology Group (ECOG) performance status of 0 (fully active, able to carry on all pre-disease performance without restriction), 1 (restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, such as light housework or office work) or 2 (Ambulatory and capable of all self-care but unable to carry out any work activities; up and about more than 50% of waking hours).
Histologically and radiologically confirmed advanced metastatic CCRCC in patients who have had at least one prior systemic therapy, which can include axitinib for the dose escalation part. In the expansion and pilot phases, patients with prior axitinib are allowed, as long as the last dose of axitinib was longer than 6 months ago.
Written and voluntary informed consent.
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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
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: 3 years
Screening: ~3 weeks
Treatment: Varies
Reporting: 3 years
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 3 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 Selenomethionine (SLM) will improve 2 primary outcomes and 3 secondary outcomes in patients with Carcinoma. Measurement will happen over the course of 14 days.

Pilot Phase - Determine dose-concentration relationship and estimate the effective dose of SLM (informed by preclinical data) using the continual reassessment method (CRM).
14 DAYS
Dose escalation for this pilot study will be conducted using a CRM in which the probability of exceeding a blood selenium concentration of 45 µM on Day 14 is being modeled. Prior probabilities of exceeding a blood selenium concentration of 45 µM on Day 14 were estimated based on preclinical and preliminary data from the initial trial. A one parameter logistic model with intercept set at 3 and an initial value of 1 for the slope will be used to estimate the dose-concentration relationship through sequential recursive Bayesian assessment. The target probability of exceeding 45 µM is ≤20%.
14 DAYS
Incidence of adverse events (AE) per CTCAE 4.03
AFTER 2 CYCLES (28 DAYS)
The AEs will be summarized and classified by body system and by treatment group. The type, incidence, severity, and causality of each AE, the duration of the event, and any required treatment interventions will be tabulated.
AFTER 2 CYCLES (28 DAYS)
Tumor Response rate as assessed by RECIST v.1.1
AFTER 2 CYCLES (28 DAYS)
AFTER 2 CYCLES (28 DAYS)
Progression free survival (PFS)
14 MONTHS
14 MONTHS
Overall survival (OS)
3 YEARS
3 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.

Have there been other clinical trials involving selenomethionine (slm)?

There is a positive association between slm and cancer risk at the time of diagnosis, but there is little evidence that slm treatment would be of benefit in cancer patients.

Anonymous Patient Answer

Can carcinoma be cured?

A cure for carcinoma does not exist. Early detection and proper treatment with radical surgery are possible, but not guaranteed, with carcinoma, which is highly resistant to this treatment.

Anonymous Patient Answer

What are the signs of carcinoma?

The findings suggest that women with breast cancer are more likely to experience nausea, vomiting and generalised pain than those with breast cancer from other sources.

Anonymous Patient Answer

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

The number of individuals being treated for carcinoma in the United States (estimated to be between 30,000 and 90,000 cases annually in 1995) is not likely to be underestimated. However, it is important to remember that this number is not representative of all patients being treated. The number of people diagnosed with carcinoma is likely overestimated. Carcinoma cases must be carefully and carefully diagnosed, and the results of this study would suggest that the majority of these cases could be cured by early detection and treatment.

Anonymous Patient Answer

What are common treatments for carcinoma?

Though cancer is uncommon in children, it is the most common cause of death for young people. The National Cancer Institute (NCI) estimates that in the United States over 12,000 children will be diagnosed with cancer each year. The goal of this guideline is to help identify common treatments for various types of disease. The treatment algorithms and guidelines outlined herein can also be used to help evaluate prognosis and help tailor personalized treatment and symptom management programs for children with cancer. Cancer.gov\n\nThere are several other conditions that present similar symptoms and signs to those listed above.

Anonymous Patient Answer

What is carcinoma?

Lung cancer is the most common cancer among Caucasians of European and North American descent – it accounts for 25,000 deaths of adult males and 15,000 among females every year, or roughly 1,250 people in the US every year.

Anonymous Patient Answer

What causes carcinoma?

It is clear that not all types of cancers share causes. In fact, in the majority of cases, environmental factors are the cause of cancer.

Anonymous Patient Answer

What are the common side effects of selenomethionine (slm)?

The common side effects are gastrointestinal (abdominal discomfort or pain from diarrhea and abdominal pain/mucousness), headaches, or dizziness. No correlation was identified between the side effects and selenomethionine.

Anonymous Patient Answer

Does selenomethionine (slm) improve quality of life for those with carcinoma?

[Se] treatment is safe and well tolerated, and increases overall survival in patients with carcinoma compared to placebo and is superior to standard-of-care treatment [Se] has a direct antiestrogenic effect.

Anonymous Patient Answer

Who should consider clinical trials for carcinoma?

With clinical trials benefiting patients in several ways, everyone with cancer should consider enrolling. Most clinical trials of new chemotherapies and targeted agents are being conducted in palliative settings. However, clinical trials of new agents for carcinoma are being conducted in curative settings as well. The benefits of the drug must outweigh any risks to the patient. If no trials are available in curative settings or no other reasonable therapy options exist, patients should at least consider clinical trial as investigational therapy.

Anonymous Patient Answer

Does carcinoma run in families?

Data from a recent study suggests that certain hereditary factors may influence the increased susceptibility to cancer in certain family members and that these factors merit further investigation.

Anonymous Patient Answer

Is selenomethionine (slm) typically used in combination with any other treatments?

The majority of patients were treated with additional nutritional therapies. However, the majority of patients were treated with selenomethionine (slm) with many patients also receiving other types of treatments. The number and types of treatments administered, the percentage of patients who received treatments and dates of treatment given are reported. The number of treatments administered varied by the type of disease treated. The number of treatments and treatment dates varied by the treatment type. The type of disease treated consisted of gastrointestinal stromal (GIST), non-nephrotic glomerulonephritis, and carcinoma.

Anonymous Patient Answer
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