RECRUITING

Cyclophosphamide and Sirolimus for the Treatment of Metastatic, RAI-refractory, Differentiated Thyroid Cancer

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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. Cycle length will be 28 days. Patients will be monitored closely for toxicity and undergo imaging to evaluate efficacy once every 2 cycles.

Official Title

An Open Label Phase II Trial Evaluating the Efficacy of Cyclophosphamide and Sirolimus for the Treatment of Metastatic, RAI-refractory, Differentiated Thyroid Cancer

Quick Facts

Study Start:2017-04-27

Study Completion:2025-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT03099356

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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 Sirolimus * 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, small bowel resection) including dependence on a G-Tube for administration of medications. * 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

Inclusion Criteria

Exclusion 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 Sirolimus
* 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, small bowel resection) including dependence on a G-Tube for administration of medications.
* 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

Contacts and Locations

Study Contact

Cancer AnswerLine

CONTACT

1-800-865-1125

canceranswerline@umich.edu

Paul Swiecicki, M.D.

CONTACT

pswiecic@med.umich.edu

Principal Investigator

Paul Swiecicki, M.D.

PRINCIPAL_INVESTIGATOR

University of Michigan Rogel Cancer Center

Study Locations (Sites)

University of Michigan Cancer Center

Ann Arbor, Michigan, 48109

United States

Collaborators and Investigators

Sponsor: University of Michigan Rogel Cancer Center

Paul Swiecicki, M.D., PRINCIPAL_INVESTIGATOR, University of Michigan Rogel Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2017-04-27

Study Completion Date2025-12

Study Record Updates

Study Start Date2017-04-27

Study Completion Date2025-12

Terms related to this study

Additional Relevant MeSH Terms

Metastatic Thyroid Cancer