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New treatment option for Metastatic Thyroid Cancer
Official title Cyclophosphamide and Sirolimus for the Treatment of Metastatic, RAI-refractory, Differentiated Thyroid Cancer
ClinicalTrials.gov ID: NCT03099356
What this study is testing
What is Cyclophosphamide?
Cyclophosphamide is an investigational medicine, being studied as a potential treatment for metastatic thyroid cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study will be a non-randomized pilot trial using Cyclophosphamide and Sirolimus for the treatment of metastatic differentiated thyroid cancer. Patients will be treated with Sirolimus 4 mg, PO, days 1-28 as well as Cyclophosphamide 100 mg, PO, days 1-5 and 15-19.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Histologically documented differentiated thyroid cancer with or without metastases, not amenable to curative treatment; or the patient has documented...
- Measurable disease (\>10 mm) and have progression of disease based on RECIST criteria. Previously irradiated tumor lesions are not considered...
- Previous failure of Iodine-131 (131I) therapy or not candidates to receive 131I as assessed by treating physician.
- Age ≥ 18 years
- ECOG (Eastern Cooperative Oncology Group) performance status 0-2
You likely can't join if
- Inability to obtain Foundation One testing on archival tissue, or, lack of previous Next Generation Sequencing
- Chemotherapy, tyrosine kinase inhibitor, or radiation therapy within 4 weeks
- Prior experimental therapy within 4 weeks of planned start of this trial
- 131I therapy within 24 weeks before entry (4 weeks if negative post-treatment scan)
- Previous treatment with an mTOR inhibitor
- Patients who are currently receiving treatment with strong inhibitors or inducers of CYP3A4 or P-glycoprotein that cannot be discontinued at least...
See the full eligibility criteria
- 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.
- Previous failure of Iodine-131 (131I) therapy or not candidates to receive 131I as assessed by treating physician.
- Age ≥ 18 years
- ECOG (Eastern Cooperative Oncology Group) performance status 0-2
- Life expectance of ≥ 12 weeks
- 131I therapy not allowed within 24 weeks before entry (4 weeks if negative post-treatment scan)
- Adequate organ and marrow function
- Women of childbearing potential must have a negative serum or urine pregnancy test within 3 days prior to treatment
- Signed and dated informed consent document indicating that the patient (or legally acceptable representative) has been informed of all pertinent aspects of the trial prior to enrollment
- Willingness and ability to comply with scheduled visits, treatment plans, including willingness to take study medication, laboratory tests, and other study procedures
- Inability to obtain Foundation One testing on archival tissue, or, lack of previous Next Generation Sequencing
- Chemotherapy, tyrosine kinase inhibitor, or radiation therapy within 4 weeks
- Prior experimental therapy within 4 weeks of planned start of this trial
- 131I therapy within 24 weeks before entry (4 weeks if negative post-treatment scan)
- Previous treatment with an mTOR inhibitor
- Patients who are currently receiving treatment with strong inhibitors or inducers of CYP3A4 or P-glycoprotein that cannot be discontinued at least one week prior to the start of treatment with Cyclophosphamide and...
- Impairment of GI (gastrointestinal) function or GI disease that may significantly alter the absorption of study medications (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome...
- A serious uncontrolled medical disorder or active infection that would impair their ability to receive study treatment
- Patients with known sensitivities to either cyclophosphamide and/or sirolimus
- Patients with known urinary outflow obstruction
- Dementia or significantly altered mental status that would prohibit the understanding or rendering of informed consent and compliance with the requirements of this protocol
- Patients (male and female) having procreative potential who are not willing or not able to use adequate contraception or practicing abstinence
- Women who are pregnant or breast-feeding
- Patients residing in prison
The study team makes the final eligibility decision.
Where it's taking place
- Ann Arbor, Michigan, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Ann Arbor, Michigan, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.