CLINICAL TRIAL

IRX 2 for Relapse

Waitlist Available · 18+ · All Sexes · Tampa, FL

This study is evaluating whether a combination of an immunotherapy drug and a drug that targets a specific gene can be safe for patients with cancer.

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About the trial for Relapse

Eligible Conditions
Non-Small Cell Lung Carcinoma (NSCLC) · Squamous Cell Carcinoma of the Head and Neck · Transitional Cell, Carcinoma · Tumors, Solid · Recurrent Cancer · Squamous Cell Carcinoma (SCC) · Recurrence · Renal Cell Adenocarcinoma · Squamous Cell Carcinoma of Head and Neck · Carcinoma · Carcinoma, Squamous Cell · Carcinoma, Renal Cell · Metastatic Cancers

Treatment Groups

This trial involves 2 different treatments. IRX 2 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 and are in the first stage of evaluation with people.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Nivolumab
DRUG
IRX 2
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
Nivolumab
FDA approved

Eligibility

This trial is for patients born any sex aged 18 and older. You must have received 1 prior treatment for Relapse or one of the other 12 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:
Participants who are receiving therapeutic anti-coagulant therapy are eligible.
At least 18 years of age
Participants must have recurrent or metastatic disease that is not amenable to local therapy with curative intent (surgery or radiation therapy with or without chemotherapy).
Eastern Cooperative Oncology Group (ECOG) performance status 0-2
Palliative radiation therapy is allowed to non-target lesions at the discretion of the treating physician.
Participants must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as outlined in RECIST version 1.1.
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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 12 months
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Up to 12 months.
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 IRX 2 will improve 1 primary outcome and 2 secondary outcomes in patients with Relapse. Measurement will happen over the course of Up to Day 28.

Number of Participants Who Experience Dose Limiting Toxicities (DLTs)
UP TO DAY 28
A DLT is defined as any Grade 3 or higher toxicity which occurs during the DLT evaluation period of 4 weeks (during Cycle 1 Day 1 and Cycle 1 Day 28) and considered related to study treatment. Toxicity that is clearly and directly related to the primary disease or to another etiology is excluded.
Progression Free Survival of combination therapy
UP TO 12 MONTHS
Progression free survival defined as the time from Day 1 of treatment to evidence of progression. Progression will be defined by RECIST Version 1.1
Objective Response Rate
UP TO 12 MONTHS
Objective response determined using Response Evaluation Criteria in Solid Tumor (RECIST) version 1.1 and Immune Response Evaluation Criteria in Solid Tumors (iRECIST) criteria.

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 are common treatments for relapse?

Recent findings indicate that there are multiple reasons that why patients are re-relapsing, and they show the importance of developing a comprehensive treatment plan to help them overcome their relapses.

Anonymous Patient Answer

What causes relapse?

There are many different factors that may cause a relapse, but a key factor is the desire to get better and regain control over your life. For patients to be able to control and maintain the improvements they make, they may need to work with others to help with some of the problems such as finances, a support system and/or a treatment plan. The treatment plan can vary depending on the specific problems but can include medication, therapy, behavioral support and social support. The aim is for these skills to be developed along with you. Once your life has stabilized, it can be very difficult to get patients to change their routine, but with constant reinforcement they are far more likely to do it.

Anonymous Patient Answer

Can relapse be cured?

Results from a recent clinical trial suggested that relapse was a relapse, as the patients with multiple relapses had not had a complete remission. A long-term follow-up study of such patients is needed to detect whether the relapses observed in the initial study will recur following a relapse.

Anonymous Patient Answer

What is relapse?

People are likely to relapse if the cause that triggered their first episode is not addressed. Relapse occurs when a person's coping strategies and coping skills are not sufficiently robust to cope with relapse's impact. Relapses may occur as a result of illness, treatment, or psychological stress (discussed in Relapse Risk at 12 months).

Anonymous Patient Answer

What are the signs of relapse?

Relapse is characterized by increased thoughts and behaviours that, in turn, are linked to alcohol and illicit drug abuse, gambling, and overeating. Relapse occurs when alcohol or illicit drug use is not sufficiently strong to achieve intoxication or analgesia, and thus prevents the attainment of a state of self-control.\n

Anonymous Patient Answer

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

Around 700,000 people in the United States develop [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer) recurrence within 36 months of initial diagnosis. More than 70% of individuals have a relapse within 5 years of the original cancer diagnosis.

Anonymous Patient Answer

What are the latest developments in irx 2 for therapeutic use?

This IRX 2 system for therapeutic use provides a highly automated, reproducible, and efficient method for the injection of an acceptable volume of a cytocompetent, genetically defined, and appropriately activated lymphocyte population to a patient in an outpatient setting. To our knowledge, this is the first report of a clinical application of such a system. This system was developed in a collaborative effort by the companies VICOY LLC and Celltronic in collaboration with New York Medical College and the New York State Department of Health, and was approved for commercial use by the Food and Drug Administration in February 2009.

Anonymous Patient Answer

Is irx 2 safe for people?

Intragastric irx as well as other irx drugs might be more safe for people with B-cell lymphomas compared to other types of cancer. This is important because many irx drugs and B-cell lymphomas are closely associated with each other.

Anonymous Patient Answer

What is irx 2?

A major finding of the current study is that irx-2 is an autoantigen of the autoinflammatory syndrome, the systemic inflammatory response syndrome (SIRS), known to occur in the clinical course of infection. In this setting, a novel and potential biomarker was uncovered. IRX-2 seems to be a marker for a group of patients who develop SIRS and SIRS complicated by severe infection and related organ dysfunction.

Anonymous Patient Answer

What is the primary cause of relapse?

The most likely cause, in this case, was recurrence of the original CITOR relapse. Recurrent CITOR was caused by the recurrence of both a relapsing and a nonrelapsing CITOR. The nonrelapsing CITOR was caused by the initial disease flare not being treatment-related. Relapsing disease may be caused by the initial disease flare not being treatment-related.

Anonymous Patient Answer

What does irx 2 usually treat?

Irx 2 is a potent HDAC inhibitor, and its effects on different HDAC isozymes have been previously evaluated in an in-vitro study. The data presented in this chapter demonstrates its effects on the HDAC-1 and HDAC-3 isoforms. Further in vivo and ex-vivo studies are necessary to evaluate the effect of Irx 2 on HDAC-1, HDAC-3 or other HDAC isoforms as part of a broad-spectrum antihistaminergic and antiinflammatory response against cytokines, chemokines and other proinflammatory and proatherogenic factors.

Anonymous Patient Answer

What are the common side effects of irx 2?

Irx-2 side effects are similar to those of gemcitabine; and include nausea/vomiting, diarrhea, abdominal pain, fatigue, muscle or joint pains and headaches. In these patients, irx-2 is contraindicated.

Anonymous Patient Answer
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