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REVLIMID® (Lenalidomide) for Therapy of Radioiodine-Unresponsive Papillary and Follicular Thyroid Carcinomas

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00287287
Recruitment Status : Completed
First Posted : February 6, 2006
Results First Posted : June 12, 2020
Last Update Posted : June 12, 2020
Celgene Corporation
Information provided by (Responsible Party):
Kenneth Ain, University of Kentucky

Brief Summary:
The primary objective of the study is to assess the anti-tumor activity of REVLIMID® (lenalidomide), administered as a single agent, in patients with distantly metastatic thyroid carcinomas which are unresponsive to systemic radioiodine, in terms of tumor response and response duration.

Condition or disease Intervention/treatment Phase
Thyroid Neoplasms Drug: Lenalidomide Phase 2

Detailed Description:

Thalidomide has found new uses as a tumor anti-angiogenesis agent that is capable of diminishing the proliferation of angiogenesis-dependent solid malignancies. Distantly metastatic, unresectable medullary thyroid carcinomas, as well as de-differentiated papillary and follicular thyroid carcinomas, which no longer concentrate radioiodine, have no known effective systemic therapies. We have verified, in the context of a completed phase 2 clinical trial, that thalidomide has significant activity in thyroid carcinomas that are no longer radioiodine avid and are rapidly progressive. This activity has only limited durability of around 7 months and is associated with significant toxicities of sedation, constipation and neuropathy.

REVLIMID® (lenalidomide) is an analog of thalidomide with the chemical name, alpha-(3-aminophthalimido) glutarimide. REVLIMID® is noted to be more potent than thalidomide in inhibiting the production of TNF-alpha. It has more than doubled the inhibition of microvessel growth at the same concentration as thalidomide in a rat aorta angiogenesis model as well as greatly enhanced activity as an IMiD. Most importantly, it lacks much of the toxicity of thalidomide, particularly in regards to somnolence, neuropathy, or biochemical effects. In fact, patients with multiple myeloma, known to be resistant to thalidomide, were still seen to exhibit clinical responses to REVLIMID®. This makes REVLIMID® an appropriate agent to investigate in a phase 2 trial in thyroid carcinoma.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Trial of REVLIMID® (Lenalidomide) for Therapy of Radioiodine-Unresponsive Papillary & Follicular Thyroid Carcinomas
Actual Study Start Date : February 2006
Actual Primary Completion Date : July 6, 2010
Actual Study Completion Date : July 6, 2010

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Lenalidomide (Revlimid)
Treatment will be initated at 25 mg/day taken in the morning. Dose adjustments may be made to alleviate toxicities.
Drug: Lenalidomide
Initial dose is 25 mg/day dose will be adjusted accordingly as needed. Dose range for the study is 5 to 25 mg/day
Other Name: Revlimid

Primary Outcome Measures :
  1. Response Rate [ Time Frame: 4 years ]
    Percentage of patients who responded to treatment (either stable disease or complete response) based on total tumor volume measurements from CT scans.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Histological confirmation of follicular, papillary, insular, or Hürthle-cell thyroid carcinoma. Histologic slides and/or tissue blocks must be reviewed at the University of Kentucky Medical Center.
  • Patients must have an unresectable, distantly metastatic tumor, which does not concentrate radioactive iodine. Alternatively, follicular or papillary thyroid carcinoma patients with large distant tumor burdens which have not sufficiently responded to more than 800 mCi I-131 cumulative therapy and are progressive (criteria #4) may be appropriate for inclusion.
  • No systemic chemotherapy agents within 4 weeks of initiation of therapy.
  • Patients must have 3 consecutive radiographic evaluations demonstrating a cumulative 30% increase in tumor volume over a period of one year or less.
  • Patients must be over the age of 18 years with the ability to understand and willing to sign an informed consent.
  • Non-pregnant (if female). Women of childbearing potential (fertile females) must have a negative serum or urine pregnancy test within one day of starting study drug. In addition, sexually active fertile female subjects must agree to adequate contraceptive methods (oral, injectable, or implantable hormonal contraceptive; tubal ligation, intrauterine device, barrier contraceptive with spermicide; or vasectomized partner) while on study drug. Men must agree to use latex condoms when having sex with fertile women.
  • Karnofsky performance status ≥ 70.
  • Baseline laboratory studies:

    • absolute neutrophil count (ANC) > 1000/mm3
    • platelet count ≥ 100 K/mm3
    • creatinine ≤ 1.5 mg/dL, and
    • transaminase levels (AST/SGOT, ALT/SGPT) ≤ 2 x upper limit of normal (ULN) (or ≤ 5 x I:M if hepatic metastases are present)
  • Disease free of other prior malignancies for ≥ 5 years, with the exception of currently treated basal cell/squamous cell carcinoma of the skin or "in-situ" carcinoma of the cervix or breast.
  • Thyroid stimulating hormone (TSH, thyrotropin) levels must be suppressed with sufficient levothyroxine to be kept beneath the normal range of the assay.

Exclusion Criteria:

  • Patients may not have had prior REVLIMID® therapy.
  • No serious concomitant medical or psychiatric illness that might interfere with informed consent or conduct of the study, including active infections that are not controlled with medication.
  • Patients must not be pregnant or breastfeeding.
  • Use of any other experimental drug or therapy within 28 days of baseline.
  • Known hypersensitivity to thalidomide.
  • The development of erythema nodosum, characterized by a desquamating rash, while taking thalidomide or similar drugs.
  • Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study.
  • Concurrent use of other anti-cancer agents or treatments, with the exception of thyrotropin-suppression by levothyroxine.
  • All subjects with central nervous system involvement, with the exception of those subjects whose central nervous system metastases have been treated with either radiotherapy and/or surgery and remain asymptomatic with no evidence of active central nervous system disease (verified by computed tomography [CT] scan or magnetic resonance imaging [MRI]) for at least 6 months.
  • Known to be positive for HIV or infectious hepatitis, type A, B, or C.
  • Patients with medullary or anaplastic thyroid carcinomas are excluded. Patients whose disease is limited to bone metastases are excluded.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00287287

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United States, Kentucky
University of Kentucky Markey Cancer Center
Lexington, Kentucky, United States, 40536
Sponsors and Collaborators
Kenneth Ain
Celgene Corporation
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Principal Investigator: Kenneth B Ain, M.D. University of Kentucky
  Study Documents (Full-Text)

Documents provided by Kenneth Ain, University of Kentucky:
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Responsible Party: Kenneth Ain, Principal Investigator, University of Kentucky Identifier: NCT00287287    
Obsolete Identifiers: NCT00381498
Other Study ID Numbers: 05-701-F3R
First Posted: February 6, 2006    Key Record Dates
Results First Posted: June 12, 2020
Last Update Posted: June 12, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Kenneth Ain, University of Kentucky:
Clinical Trials phase II
Carcinomas, thyroid
Additional relevant MeSH terms:
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Thyroid Neoplasms
Adenocarcinoma, Follicular
Thyroid Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Endocrine System Diseases
Endocrine Gland Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents