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Fluorouracil + Biological Therapy for Kidney Cancer
Phase 1
Waitlist Available
Research Sponsored by St. Luke's Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Bidimensionally measurable disease (by CT scan or MRI) outside prior irradiation port unless documented disease progression after radiotherapy
No autoimmune disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study Summary
This trial is studying how well giving fluorouracil together with biological therapy works in treating patients with metastatic kidney or colorectal cancer.
Who is the study for?
This trial is for adults with metastatic kidney or colorectal cancer who've tried standard treatments without success, declined them, or can't have them due to other illnesses. They must not be pregnant or nursing and should use contraception if fertile. Participants need functioning kidneys, lungs, liver, blood cells, no recent biologic therapy/chemotherapy/radiotherapy/surgery/steroid treatment and no active infections or autoimmune diseases.Check my eligibility
What is being tested?
The study is testing the combination of a chemotherapy drug called fluorouracil with biological therapy to see how well it works against metastatic kidney or colorectal cancer. It's in Phase I which means they're looking at safety and what dose might work best.See study design
What are the potential side effects?
Fluorouracil may cause side effects like mouth sores, diarrhea, low blood cell counts leading to increased infection risk and bleeding problems. Biological therapies could lead to flu-like symptoms such as fever and chills as well as fatigue.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer can be measured on scans and is outside the area previously treated with radiation, unless it has grown after radiation.
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I do not have an autoimmune disease.
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I do not have untreated or unstable brain metastasis.
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I am 18 years old or older.
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My liver functions are within normal limits and I don't have hepatitis B.
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My thyroid condition is under control.
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I do not have any major illnesses besides my current condition.
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My lung function is above 65% of what's expected and I don't have an untreated lung clot.
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My cancer is confirmed as metastatic kidney or colorectal cancer.
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My creatinine level is 2.0 mg/dL or lower.
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I am able to get out of my bed or chair and move around.
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I do not have any ongoing infections.
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My heart is healthy with no current severe issues.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
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Who is running the clinical trial?
St. Luke's Medical CenterLead Sponsor
12 Previous Clinical Trials
208,491 Total Patients Enrolled
John P. Hanson, MDStudy ChairSt. Luke's Medical Center
7 Previous Clinical Trials
270 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- It's been over a month since my last biologic therapy or immunotherapy.It's been over a month since my last chemotherapy, or over 6 weeks for specific types.I haven't taken any steroids or steroid-containing medicines in the last 4 weeks.I have either not responded to, cannot receive, or have refused standard treatments.My cancer can be measured on scans and is outside the area previously treated with radiation, unless it has grown after radiation.I haven't had any cancer in the past 5 years, except for treated skin cancer or cervical pre-cancer.I do not have an autoimmune disease.I am 18 years old or older.My liver functions are within normal limits and I don't have hepatitis B.My thyroid condition is under control.I do not have any major illnesses besides my current condition.My lung function is above 65% of what's expected and I don't have an untreated lung clot.It's been over a month since my last radiation treatment.My surgery status is not a factor for this trial.I do not have untreated or unstable brain metastasis.My cancer is confirmed as metastatic kidney or colorectal cancer.My creatinine level is 2.0 mg/dL or lower.I am able to get out of my bed or chair and move around.I do not have any ongoing infections.My heart is healthy with no current severe issues.My condition matches the specific disease characteristics required.
Research Study Groups:
This trial has the following groups:Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- 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
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How hazardous is this therapy for those who receive it?
"Due to the limited data surrounding efficacy and safety, our team classified this treatment's risk level as a 1. This assessment was based on it being in Phase 1 of its clinical trial process."
Answered by AI
Are researchers currently accepting new participants into this clinical trial?
"Contrary to our expectations, clinicaltrials.gov discloses that this medical trial is not actively searching for patients although it was initially published in January 2001 and last edited on September 19th 2013. Thankfully, there are 1207 other clinical studies enrolling participants at the moment."
Answered by AI
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