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| Sponsors and Collaborators: |
Memorial Sloan-Kettering Cancer Center National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00098813 |
Purpose
RATIONALE: FR901228 may stop the growth of tumor cells by blocking the some of the enzymes needed for cell growth. It may also help radioactive iodine and chemotherapy work better by making tumor cells more sensitive to the drug.
PURPOSE: This phase II trial is studying how well FR901228 works in treating patients with recurrent and/or metastatic thyroid cancer that has not responded to radioactive iodine.
| Condition | Intervention | Phase |
|---|---|---|
|
Head and Neck Cancer |
Drug: romidepsin |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label |
| Official Title: | A Phase II Study of Single Agent Depsipeptide (FK228) in Radioiodine (RAI)-Refractory Metastatic Non-Medullary (Papillary, Follicular, and Hürthle Cell Variants) Thyroid Carcinoma |
| Estimated Enrollment: | 41 |
| Study Start Date: | October 2004 |
| Estimated Primary Completion Date: | June 2006 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: Patients receive FR901228 (depsipeptide) IV over 4 hours on days 1, 8, and 15. Treatment repeats every 28 days for up to 12 courses in the absence of unacceptable toxicity or disease progression.
PROJECTED ACCRUAL: A total of 21-41 patients will be accrued for this study within 10.5-20.5 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 non-medullary thyroid carcinoma, including the following cell types:
Measurable disease
Progressive disease during or after prior treatment, as defined by ≥ 1 of the following criteria:
Rising thyroglobulin level
Refractory to radioactive iodine (RAI)
Absent or insufficient RAI-uptake* documented by whole-body RAI scan within the past 6 months
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
No history of any of the following cardiac diseases:
Mobitz II second degree block in patients who do not have a pacemaker
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
No prior cytotoxic chemotherapy
Endocrine therapy
Radiotherapy
At least 4 weeks since prior external beam radiation therapy
At least 3 months since prior RAI therapy
Surgery
Other
Contacts and Locations| United States, New York | |
| Memorial Sloan - Kettering Cancer Center | |
| New York, New York, United States, 10021 | |
| Principal Investigator: | David G. Pfister, MD | Memorial Sloan-Kettering Cancer Center |
More Information
| Responsible Party: | Memorial Sloan-Kettering Cancer Center ( David Paul Kelsen ) |
| Study ID Numbers: | CDR0000396783, MSKCC-04059, NCI-6338 |
| Study First Received: | December 8, 2004 |
| Last Updated: | April 14, 2009 |
| ClinicalTrials.gov Identifier: | NCT00098813 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
stage IV follicular thyroid cancer stage IV papillary thyroid cancer recurrent thyroid cancer |
|
Adenocarcinoma, Follicular Thyroid Neoplasms Thyroid Cancer, Papillary Endocrine System Diseases Romidepsin Recurrence Carcinoma |
Anti-Bacterial Agents Thyroid Cancer, Follicular Head and Neck Neoplasms Iodine Endocrinopathy Thyroid Diseases 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 |