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Sponsored by: |
National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00052767 |
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.
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
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) |
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 |
Anti-Bacterial Agents Thyroid Neoplasms Head and Neck Neoplasms Romidepsin Endocrine System Diseases |
Endocrinopathy Thyroid Diseases Recurrence Endocrine Gland Neoplasms |
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 |