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

NCT00287287 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: 05-701-F3R
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Thyroid Neoplasms

Keywords

Lenalidomide; Clinical Trials phase II; Carcinomas, thyroid; Radioiodine-Unresponsive; Papillary; Follicular

Outcome Measures

Primary Outcomes (1)

• Response Rate

  Percentage of patients who responded to treatment (either stable disease or complete response) based on total tumor volume measurements from CT scans.

  4 years

Study Arms (1)

Lenalidomide (Revlimid)

EXPERIMENTAL

Treatment will be initated at 25 mg/day taken in the morning. Dose adjustments may be made to alleviate toxicities.

Drug: Lenalidomide

Interventions

Lenalidomide DRUG

Initial dose is 25 mg/day dose will be adjusted accordingly as needed. Dose range for the study is 5 to 25 mg/day

Also known as: Revlimid

Lenalidomide (Revlimid)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kenneth Ain: lead
• Celgene Corporation: collaborator

Study Sites (1)

University of Kentucky Markey Cancer Center

Lexington, Kentucky, 40536, United States

Location

MeSH Terms

Conditions

Thyroid Neoplasms

Interventions

Lenalidomide

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Endocrine System Diseases; Thyroid Diseases

Intervention Hierarchy (Ancestors)

Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Kenneth Ain
• Organization: University of Kentucky

kenneth.ain@uky.edu

8593236652

Study Officials

• Kenneth B Ain, M.D.

  University of Kentucky

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 3, 2006
• First Posted: February 6, 2006
• Study Start: February 1, 2006
• Primary Completion: July 6, 2010
• Study Completion: July 6, 2010
• Last Updated: June 12, 2020
• Results First Posted: June 12, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)