Status:
COMPLETED
RAD001 for Patients With Radioiodine Refractory Thyroid Cancer
Lead Sponsor:
Dana-Farber Cancer Institute
Collaborating Sponsors:
Massachusetts General Hospital
M.D. Anderson Cancer Center
Conditions:
Thyroid Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Since thyroid cancer becomes refractory to radioactive iodine, treatment options are very limited. Tyrosine kinase inhibitors such as sorafenib have recently shown promise. This trial seeks to expand ...
Detailed Description
* RAD001 will be taken once a day in the morning starting on Day 1 and continue until the participant is no longer participating in the study treatment. * A history and physical exam will be performed...
Eligibility Criteria
Inclusion
- Histologically confirmed locally advanced or metastatic thyroid cancer, excluding thyroid lymphomas not amenable to or refractory to surgical resection, external beam radiotherapy, radioiodine or other local therapies.
- Prior therapy with chemotherapy and targeted therapies except for mTor inhibitors is allowed.
- Medullary thyroid cancer with documented evidence of disease progression by modified RECIST within 6 months before study day 1 or symptomatic disease at the time of screening in the absence of documented disease progression.
- Differentiated thyroid cancer with documented evidence of disease progression by modified RECIST within 6 months before study day 1.
- Anaplastic thyroid cancer with disease progression with documented disease progression by modified RECIST within 6 months of study day 1.
- Patients must have at least one measurable site of disease according to RECIST criteria that has not previously irradiated. If the patient has has previous radiation to the marker lesion(s), there must be evidence of progression since radiation.
- 18 years of age or older
- WHO performance status 2 or less
- Adequate bone marrow, liver, and renal function
- Fasting serum cholesterol 300mg/dL or less OR 7.75 mmol/L or less AND fasting triglycerides 2.5x ULN or less
Exclusion
- Patients receiving anticancer therapies within last 2 weeks or who have received radiation therapy within 3 weeks of study day 1
- Prior therapy with mTOR inhibitors
- Patients who have had a major surgery or significant traumatic injury within 4 weeks of start of study drug, patients who have not recovered from the side effects of any major surgery or patients that may require major surgery during the course of the study
- Prior treatment with any investigational drug within the preceding 3 weeks
- Patients receiving chronic, systemic treatment with corticosteroids or another immunosuppressive agent. Topical or inhaled corticosteroids are allowed.
- Patients should not receive immunization with attenuated live vaccines within 2 weeks of study entry or during study period
- Uncontrolled brain or leptomeningeal metastases, including patients who continue to require glucocorticoids for brain or leptomeningeal metastases
- Other malignancies within the past 3 years except for adequately treated carcinoma of the cervix or basal or squamous cell carcinomas of the skin
- Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study
- A known history of HIV seropositivity
- Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of RAD001
- Patients with an active, bleeding diathesis
- Female patients who are pregnant or breast feeding, or adults of reproductive potential who are not using effective birth control methods
- Patients who have received prior treatment wih an mTOR inhibitor
- Patients with a known hypersensitivity to RAD001 or other rapamycins or to its excipients
- History of noncompliance to medical regimens
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 27 2020
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00936858
Start Date
July 1 2009
End Date
February 27 2020
Last Update
October 22 2021
Active Locations (4)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
2
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
3
Mt. Sinai Medical Center
New York, New York, United States, 10029
4
MD Anderson Cancer Center
Houston, Texas, United States, 77030