|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00052767 |
Purpose
RATIONALE: Drugs used in chemotherapy, such as FR901228, work in different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase I trial to study the effectiveness of FR901228 in treating patients who have refractory thyroid cancer or other advanced cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Head and Neck Cancer Unspecified Adult Solid Tumor, Protocol Specific |
Drug: romidepsin |
Phase I |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label |
| Official Title: | Phase I Trial of Romidepsin Given on Days One, Three and Five in Patients With Thyroid and Other Advanced Cancers |
| Estimated Enrollment: | 56 |
| Study Start Date: | November 2002 |
| Estimated Primary Completion Date: | February 2005 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: This is an open-label, dose-escalation study.
Patients receive FR901228 (romidepsin) IV over 4 hours on days 1, 3, and 5. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of FR901228 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 6 patients experience dose-limiting toxicity.
Once the MTD is determined, an additional cohort of 10 patients with radioiodine-refractory non-medullary thyroid cancer are treated at that dose.
PROJECTED ACCRUAL: Approximately 3-56 patients (10 with radioiodine-refractory non-medullary thyroid cancer) will be accrued for this study within 17-21 months.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed cancer for which there is no known standard therapy capable of extending life expectancy (closed to accrual as of ½8/08)
Thyroid cancer cohort (enrolled after the maximum tolerated dose for study drug has been determined):
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Concurrent corticosteroids for non-responding lesions allowed provided dose is stable
Radiotherapy
Surgery
Other
Contacts and Locations| United States, Maryland | |
| NCI - Center for Cancer Research | Recruiting |
| Bethesda, Maryland, United States, 20892 | |
| Contact: Clinical Trials Office - NCI - Center for Cancer Research 888-624-1937 | |
| Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office | Recruiting |
| Bethesda, Maryland, United States, 20892-1182 | |
| Contact: Clinical Trials Office - Warren Grant Magnusen Clinical Center 888-NCI-1937 | |
| Study Chair: | Susan E. Bates, MD | National Cancer Institute (NCI) |
More Information
| Study ID Numbers: | CDR0000258737, NCI-03-C-0030, NCI-5483 |
| Study First Received: | January 24, 2003 |
| Last Updated: | June 16, 2009 |
| ClinicalTrials.gov Identifier: | NCT00052767 History of Changes |
| Health Authority: | Unspecified |
|
unspecified adult solid tumor, protocol specific recurrent thyroid cancer |
|
Neoplasms Neoplasms by Site Thyroid Neoplasms Antineoplastic Agents Therapeutic Uses Head and Neck Neoplasms |
Romidepsin Endocrine System Diseases Antibiotics, Antineoplastic Pharmacologic Actions Thyroid Diseases Endocrine Gland Neoplasms |