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Alkylating agents
Cyclophosphamide + Sirolimus for Advanced Thyroid Cancer
Phase 2
Recruiting
Led By Paul Swiecicki, M.D.
Research Sponsored by University of Michigan Rogel Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Histologically documented differentiated thyroid cancer with or without metastases, not amenable to curative treatment; or the patient has documented refusal of curative treatment
Measurable disease (>10 mm) and have progression of disease based on RECIST criteria. Previously irradiated tumor lesions are not considered measurable unless they have progressed since radiation.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up patients will be followed until death or up to 2 years
Awards & highlights
Study Summary
This trial will study the effects of two drugs, Cyclophosphamide and Sirolimus, on thyroid cancer that has spread.
Who is the study for?
This trial is for adults over 18 with advanced thyroid cancer that's spread and doesn't respond to radioactive iodine treatment. They should be able to perform daily activities (ECOG 0-2), not have had certain treatments recently, and must agree to follow the study plan. Pregnant or breastfeeding women, those unable to use contraception, and individuals with specific health issues or sensitivities to the drugs tested are excluded.Check my eligibility
What is being tested?
The trial tests Cyclophosphamide and Sirolimus in patients with metastatic differentiated thyroid cancer. It's a non-randomized pilot study where participants take Sirolimus daily for 28 days and Cyclophosphamide on specified days within this cycle. The effectiveness is checked every two cycles through imaging.See study design
What are the potential side effects?
Potential side effects include immune system suppression leading to increased infection risk, nausea, vomiting, mouth sores from Cyclophosphamide; and mouth ulcers, high cholesterol levels, lung problems from Sirolimus. Side effects can vary based on individual patient conditions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My thyroid cancer cannot be cured by surgery or I have chosen not to undergo curative treatment.
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My cancer has grown despite treatment, and I have a tumor larger than 10 mm.
Select...
I am able to get out of my bed or chair and move around.
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Iodine-131 treatment did not work for me or I can't receive it.
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I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ patients will be followed until death or up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~patients will be followed until death or up to 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Percentage of patients that respond to treatment
Secondary outcome measures
Median overall survival time
Median progression free survival time
The number of patients that experience toxicity
Trial Design
1Treatment groups
Experimental Treatment
Group I: Cyclophosphamide and SirolimusExperimental Treatment2 Interventions
Sirolimus 4 mg, PO, days 1-28 as well as Cyclophosphamide 100 mg, PO, days 1-5 and 15-19
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sirolimus
2013
Completed Phase 4
~2750
Cyclophosphamide
1995
Completed Phase 3
~3770
Find a Location
Who is running the clinical trial?
University of Michigan Rogel Cancer CenterLead Sponsor
294 Previous Clinical Trials
24,242 Total Patients Enrolled
Paul Swiecicki, M.D.Principal InvestigatorUniversity of Michigan Rogel Cancer Center
3 Previous Clinical Trials
90 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- People who are in jail or prison.I do not have any serious health issues or infections that would stop me from receiving the study treatment.I am allergic to cyclophosphamide or sirolimus.I have a blockage in my urinary tract.I am mentally capable of understanding and following the study's requirements.I haven't had chemotherapy, radiation, or tyrosine kinase inhibitor treatments in the last 4 weeks.I have been treated with an mTOR inhibitor before.I haven't had advanced genetic testing on my cancer.I am not on strong CYP3A4 or P-glycoprotein inhibitors/inducers, or can stop them a week before starting Cyclophosphamide and Sirolimus.My stomach or intestines do not work well, affecting how I absorb medicine.I am not using, or unable to use, birth control or practice abstinence.I am not pregnant or breast-feeding.My thyroid cancer cannot be cured by surgery or I have chosen not to undergo curative treatment.My cancer has grown despite treatment, and I have a tumor larger than 10 mm.My organs and bone marrow are working well.I am willing and able to follow the study's schedule and procedures.I am able to get out of my bed or chair and move around.You are expected to live for at least 12 more weeks.Iodine-131 treatment did not work for me or I can't receive it.I have not had 131I therapy in the last 6 months, or 1 month if my post-treatment scan was negative.I haven't had 131I therapy in the last 6 months, or 4 weeks if my post-treatment scan was negative.I am 18 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: Cyclophosphamide and Sirolimus
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.
What studies have been done on the long-term effects of Sirolimus?
"Sirolimus has received a score of 2 from our team at Power. This is because, although there is data supporting its safety, this medication has not yet been proven effective in clinical trials."
Answered by AI
What is the total subject pool for this experiment?
"According to the clinicaltrials.gov website, this clinical trial is still looking for patients. This particular study was first posted on April 27th, 2017 and received its most recent update on August 15th, 2022. So far, 19 patients have been enrolled at 1 site."
Answered by AI
For what purpose is Sirolimus most often prescribed?
"Sirolimus is a medication that's frequently used in organ transplantation procedures. Additionally, it has shown to be helpful for patients with multiple sclerosis, leukemia, myelocytic, acute conditions, and retinoblastoma."
Answered by AI
Are new participants being accepted for this experiment?
"The online registry, clinicaltrials.gov, shows that this trial is open and looking for patients. This particular study was first advertised on April 27th, 2017 with the most recent update being from August 15th, 2022."
Answered by AI
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