RAD001 for Patients With Radioiodine Refractory Thyroid Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Massachusetts General Hospital
M.D. Anderson Cancer Center
Mount Sinai Hospital, New York
Novartis
Information provided by (Responsible Party):
Jochen Lorch, MD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT00936858
First received: July 9, 2009
Last updated: January 16, 2014
Last verified: January 2014
  Purpose

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 treatment options for this disease with a new, oral drug called RAD001. It is an inhibitor of the mTOR pathway and has shown activity in neuroendocrine cancers of the gastrointestinal tract and has been approved for the treatment of metastatic renal cell cancer.


Condition Intervention Phase
Thyroid Cancer
Drug: RAD001
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Trial Using RAD001 for Patients With Radioiodine Refractory Thyroid Cancer

Resource links provided by NLM:


Further study details as provided by Dana-Farber Cancer Institute:

Primary Outcome Measures:
  • Progression free survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Objective response rate (complete and partial responses by modified RECIST criteria) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • 1 year survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 33
Study Start Date: July 2009
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: RAD001
RAD001 will be administered orally as once daily dose of 10 mg (one 10mg tablet or two 5mg tablets) continuously from study day 1 until progression of disease or unacceptable toxicity.
Drug: RAD001
Taken orally once a day in the morning
Other Name: Afinitor (everolimus)

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 the first day of the study and then once a month. Blood tests including coagulation studies, and thyroid studies will be performed monthly. A urine sample will need to be provided on the first day of treatment and then every 2 months. Imaging consisting of a CT or MRI of the neck, chest and abdomen will be done every 8 weeks after starting RAD001.
  • Participants will remain on this research study for up to 24 months. However, if the participants doctor feels that they are benefiting from the study drug and they do not have severe side effects, they may be given the option to continue taking RAD001.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00936858

Locations
United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
United States, New York
Mt. Sinai Medical Center
New York, New York, United States, 10029
United States, Texas
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
Dana-Farber Cancer Institute
Massachusetts General Hospital
M.D. Anderson Cancer Center
Mount Sinai Hospital, New York
Novartis
Investigators
Principal Investigator: Jochen Lorch, MD Dana-Farber Cancer Institute
  More Information

No publications provided

Responsible Party: Jochen Lorch, MD, Medical Oncology, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT00936858     History of Changes
Other Study ID Numbers: 09-049
Study First Received: July 9, 2009
Last Updated: January 16, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Dana-Farber Cancer Institute:
radioiodine refractory thyroid cancer
RAD001

Additional relevant MeSH terms:
Thyroid Neoplasms
Thyroid Diseases
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Endocrine System Diseases
Sirolimus
Everolimus
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antifungal Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on July 20, 2014