Thyroid NeoplasmsPhase 2NCT00287287
REVLIMID® (Lenalidomide) for Therapy of Radioiodine-Unresponsive Papillary and Follicular Thyroid Carcinomas
A Phase 2 study testing Lenalidomide in people with Thyroid Neoplasms, run by Kenneth Ain at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thyroid Neoplasms
- What is being tested?
- Lenalidomide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2006to 6 Jul 2010
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kentucky Markey Cancer Center
Lexington, Kentucky, 40536
About this study
Official title: Phase II Trial of REVLIMID® (Lenalidomide) for Therapy of Radioiodine-Unresponsive Papillary & Follicular Thyroid Carcinomas
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.
Read the 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.
- Conditions
- Thyroid Neoplasms
- Being tested
- Lenalidomide
- Keywords
- Lenalidomide, Clinical Trials phase II, Carcinomas, thyroid, Radioiodine-Unresponsive, Papillary, Follicular
- Medical subject headings
- Thyroid Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LenalidomideDrug
Also called Revlimid
Initial dose is 25 mg/day dose will be adjusted accordingly as needed. Dose range for the study is 5 to 25 mg/day
| Study group | Role | What they receive |
|---|---|---|
| Lenalidomide (Revlimid) | Experimental | Treatment will be initated at 25 mg/day taken in the morning. Dose adjustments may be made to alleviate toxicities. Receives: Drug: Lenalidomide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response Rate
Percentage of patients who responded to treatment (either stable disease or complete response) based on total tumor volume measurements from CT scans.
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2006 (estimated)
- Study startFeb 2006
- Primary completion6 Jul 2010
- Study completion6 Jul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Thyroid NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kenneth Ain
- Sponsor type
- University, hospital or other
- Collaborators
- Celgene Corporation
- Responsible party
- Sponsor-investigator, Kenneth Ain, University of Kentucky
- Investigators
- Kenneth B Ain, M.D., Principal investigator, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00287287
- Sponsor's protocol ID
- 05-701-F3R
- Status last verified
- May 2020
- First submitted
- 3 Feb 2006
- Last updated
- 12 Jun 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Trial of REVLIMID® (Lenalidomide) for Therapy of Radioiodine-Unresponsive Papillary & Follicular Thyroid Carcinomas
- ClinicalTrials.gov ID
- NCT00287287
- Acronym / sponsor ID
- 05-701-F3R
- Conditions
- Thyroid Neoplasms
- Keywords
- Lenalidomide, Clinical Trials phase II, Carcinomas, thyroid, Radioiodine-Unresponsive, Papillary, Follicular
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Kenneth AinUniversity, hospital or other
- Collaborators
- Celgene Corporation
- Study start
- Feb 2006 (actual)
- Primary completion
- 6 Jul 2010 (actual)
- Study completion
- 6 Jul 2010 (actual)
- First posted
- 6 Feb 2006 (estimated)
- Results
- Posted 12 Jun 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lenalidomide (Revlimid) | Experimental | Drug: LenalidomideTreatment will be initated at 25 mg/day taken in the morning. Dose adjustments may be made to alleviate toxicities. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LenalidomideAlso: RevlimidInitial dose is 25 mg/day dose will be adjusted accordingly as needed. Dose range for the study is 5 to 25 mg/day | Drug | Lenalidomide (Revlimid) |
Primary outcome
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kenneth B Ain, M.D. principal investigator
University of Kentucky
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Lenalidomide in people with Thyroid Neoplasms, run by Kenneth Ain at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Jun 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response Rate (time frame: 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2020.