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rSIFN-co for Cancer
Study Summary
This trial will test different doses of a new drug to find the safest and most effective dose. The trial will enroll additional subjects at each dose level until a total of 9 subjects have completed the trial without having any serious side effects.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I regularly use steroid medication.I do not have any severe health or mental conditions that could make this study risky for me.I have not had any non-healing wounds, fractures, or ulcers in the last 28 days.I haven't taken mTOR inhibitor therapy in the last 4 weeks.My cancer is one of the specified types and is getting worse despite treatment.I have had chemotherapy, immunotherapy, surgery, or radiation for cancer before.My liver is functioning well, with normal bilirubin and enzyme levels.My blood tests show normal levels of hemoglobin, white blood cells, and platelets.I agree to use contraception if I am not sterile.I do not have uncontrolled HIV, hepatitis B, or C.I have a history of blood clots but am on medication to manage it.I can carry out all my usual activities without help.My kidney function is within the normal range.I am currently being treated for a serious infection.I have a severe medical condition that is not under control.I am 18 years old or older.I am able to understand and agree to participate in the study.I have an autoimmune disorder or uncontrolled diabetes.I haven't had cancer treatment or surgery in the last 4 weeks.I had a blood clot in an artery in the last 6 months.I have a history of epilepsy, depression, or other mental health issues.I am not pregnant or breastfeeding and use birth control.
- Group 1: sSIFN-co
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
How many individuals are eligible for enrollment in this experiment?
"This clinical trial is no longer taking on participants. It initially opened for enrollment in January 2016 and was last updated June 16th 2022. However, if you are searching for other trials, there are 165 medical studies that require people with kidney issues as well as 1 study looking to enrol those dealing with rSIFN-co."
Has there been a similar research effort in the past?
"Since 2016, the drug rSIFN-co has undergone extensive research. Medelis Inc. initiated its first clinical trial in that year with 36 participants and successfully completed Phase 1 Drug Approval Stage by 2020. Currently, this organisation is sponsoring one active study on the medication."
What criteria must someone meet to be eligible for this research endeavor?
"This clinical trial is in need of 36 volunteers that are aged 18 and 80, suffering from advanced solid tumors such as melanoma, kidney cancer, lung cancer, colorectal carcinoma, prostate cancer or neuroendocrine tumor. To be eligible for consideration applicants must comply with the following criteria: gender (male/female), Eastern Cooperative Oncology Group Performance Status level less than 1; have at least one target lesion according to RECIST 1.1 standards; prior systemic chemotherapy permitted; adequate hepatic function (total bilirubin ≤2 ULN); creatinine clearance greater than 40ml/min.; hemoglobin"
What other research projects have utilized rSIFN-co as a part of their study?
"As of now, 1 study is ongoing for rSIFN-co with none at Phase 3. Most experiments are conducted in Chicago, Illinois; however, other 4 locations have studies underway as well."
Are there still open slots for participants in this trial?
"This investigation has concluded its recruitment process. The initial posting of the trial occurred on January 1st, 2016 with a final edit made June 16th 2022. If you are searching for other studies there are presently 165 trials enrolling patients experiencing kidney-related issues and one study recruiting participants with rSIFN-co."
Do the criteria for this medical trial include individuals aged 45 and older?
"This clinical trial has a wide age range for enrollment, with the lower limit set at 18 and the upper boundary being 80 years old."
What implications does administering rSIFN-co have for individuals’ well-being?
"There is scant clinical data affirming the safety and efficacy of rSIFN-co, so it received a rating of 1 on our scale."
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