Head and Neck CancerPhase 2NCT00026533
Thalidomide in Treating Patients With Thyroid Cancer
A Phase 2 study testing thalidomide in people with Head and Neck Cancer, run by Kenneth Ain at 1 site in United States.
Trial summary
RATIONALE: Thalidomide may stop the growth of thyroid cancer by stopping blood flow to the tumor. PURPOSE: Phase II trial to study the effectiveness thalidomide in treating patients who have thyroid cancer. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Head and Neck Cancer
- What is being tested?
- thalidomide
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Jun 2001to Dec 2005
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically confirmed follicular, papillary, insular, or medullary thyroid carcinoma
- Must meet criteria for 1 of the following:
- Unresectable, distantly metastatic tumor that does not concentrate radioactive iodine
- Follicular or papillary thyroid carcinoma with a large distant tumor burden that has not sufficiently responded to cumulative iodine I 131 doses exceeding 800 mCi
- Radiographic evidence of tumor progression, meeting 1 of the following criteria:
- Evidence gathered over a period of at least 1 year with at least 3 separate x-ray studies, defining tumor volume
- Similar radiographic evidence over a shorter period of time, delineating more than 30% increase in tumor volume
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- Karnofsky 70-100%
Life expectancy:
- Not specified
Hematopoietic:
- Absolute neutrophil count at least 750/mm^3
- Hemoglobin at least 10.5 g/dL
Hepatic:
- Bilirubin no greater than 1.5 times upper limit of normal (ULN)
Renal:
- Creatinine no greater than 1.5 times ULN
- BUN no greater than 1.5 times ULN
Other:
- No active infection not controlled with medications
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective double contraception (1 hormonal method plus 1 barrier method OR 2 simultaneous barrier methods) for female patients or barrier contraception for male patients for more than 4 weeks prior to, during, and for at least 4 weeks after study participation
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- No prior thalidomide
- No other concurrent biologic therapy
Chemotherapy:
- At least 4 weeks since prior systemic chemotherapy
- No concurrent systemic chemotherapy
Endocrine therapy:
- Not specified
Radiotherapy:
- See Disease Characteristics
- Prior radiotherapy allowed
- Concurrent limited external-beam radiotherapy to isolated sites of bony metastases allowed, provided that these sites are not the sole sites of metastatic disease and do not constitute the sites of evaluable disease for this study
- No concurrent radioiodine therapy
Surgery:
- See Disease Characteristics
- Prior surgery allowed
- Concurrent surgery allowed to sites that do not constitute evaluable disease for this study
Other:
- No concurrent medications that are known to increase the risk of peripheral neuropathy
Trial locations and contacts
1 site in 1 country.
United States1 site
Albert B. Chandler Medical Center, University of Kentucky
Lexington, Kentucky, 40536-0298
About this study
Official title: Phase II Trial of Thalidomide for Therapy of Radioiodine-Unresponsive Papillary and Follicular Thyroid Carcinomas and Medullary Thyroid Carcinomas
RATIONALE: Thalidomide may stop the growth of thyroid cancer by stopping blood flow to the tumor.
PURPOSE: Phase II trial to study the effectiveness thalidomide in treating patients who have thyroid cancer.
Read the detailed description
OBJECTIVES:
- Determine the antitumor activity of thalidomide, in terms of tumor response and duration of response, in patients with metastatic follicular, papillary, or medullary thyroid carcinoma that is unresponsive to systemic radioiodine.
- Compare the differences in antitumor activity of this drug in patients with medullary carcinomas vs those with papillary or follicular carcinomas.
- Determine the toxic effects and duration of toxic effects of this drug in these patients.
OUTLINE: Patients receive oral thalidomide once daily for 2 weeks and then twice daily. Treatment continues for 1 year in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A maximum of 50 patients will be accrued for this study.
- Conditions
- Head and Neck Cancer
- Being tested
- thalidomide
- Keywords
- stage IV papillary thyroid cancer, stage IV follicular thyroid cancer, thyroid gland medullary carcinoma, recurrent thyroid cancer, insular thyroid cancer
- Medical subject headings
- Head and Neck Neoplasms, Thyroid Cancer, Papillary, Adenocarcinoma, Follicular, Carcinoma, Medullary, Thyroid Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
thalidomideDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study startJun 2001
- Primary completionNov 2003
- Study completionDec 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancerStudies 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
Sponsor and investigators
- Lead sponsor
- Kenneth Ain
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor-investigator, Kenneth Ain, University of Kentucky
- Investigators
- Kenneth Ain, MD, Study chair, Lucille P. Markey Cancer Center at University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00026533
- Sponsor's protocol ID
- CDR0000069053
- Other IDs
- UKMC-IRB-010069
- Status last verified
- Jun 2017
- First submitted
- 9 Nov 2001
- Last updated
- 6 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Trial of Thalidomide for Therapy of Radioiodine-Unresponsive Papillary and Follicular Thyroid Carcinomas and Medullary Thyroid Carcinomas
- ClinicalTrials.gov ID
- NCT00026533
- Acronym / sponsor ID
- CDR0000069053
- Conditions
- Head and Neck Cancer
- Keywords
- stage IV papillary thyroid cancer, stage IV follicular thyroid cancer, thyroid gland medullary carcinoma, recurrent thyroid cancer, insular thyroid cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Kenneth AinUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jun 2001
- Primary completion
- Nov 2003 (actual)
- Study completion
- Dec 2005 (actual)
- First posted
- 27 Jan 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Thalidomide may stop the growth of thyroid cancer by stopping blood flow to the tumor.
PURPOSE: Phase II trial to study the effectiveness thalidomide in treating patients who have thyroid cancer.
Detailed description
OBJECTIVES:
- Determine the antitumor activity of thalidomide, in terms of tumor response and duration of response, in patients with metastatic follicular, papillary, or medullary thyroid carcinoma that is unresponsive to systemic radioiodine.
- Compare the differences in antitumor activity of this drug in patients with medullary carcinomas vs those with papillary or follicular carcinomas.
- Determine the toxic effects and duration of toxic effects of this drug in these patients.
OUTLINE: Patients receive oral thalidomide once daily for 2 weeks and then twice daily. Treatment continues for 1 year in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A maximum of 50 patients will be accrued for this study.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| thalidomide | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2017.
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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 Ain, MD study chair
Lucille P. Markey Cancer Center at 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 thalidomide in people with Head and Neck Cancer, 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?
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 6 Jun 2017. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
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 6 Jun 2017.