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Sponsors and Collaborators: |
Mayo Clinic National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00118248 |
RATIONALE: Drugs used in chemotherapy, such as 17-AAG, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
PURPOSE: This phase II trial is studying how well 17-AAG works in treating patients with inoperable locoregionally advanced or metastatic thyroid cancer.
Condition | Intervention | Phase |
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Head and Neck Cancer |
Drug: tanespimycin |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase II Trial of 17-Allylaminogeldanamycin (17AAG) in Advanced Medullary and Differentiated Carcinoma of the Thyroid |
Estimated Enrollment: | 72 |
Study Start Date: | December 2004 |
Estimated Primary Completion Date: | June 2006 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study. Patients are stratified according to type of thyroid carcinoma (medullary vs differentiated).
Patients receive 17-N-allylamino-17-demethoxygeldanamycin (17-AAG) IV over 2-6 hours on days 1, 4, 8, and 11.
Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 3 months until disease progression and then every 6 months for up to 3 years from study entry.
PROJECTED ACCRUAL: A total of 28-72 patients (14-36 per stratum) will be accrued for this study within 24 months.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of thyroid carcinoma of 1 of the following types:
Differentiated
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Immunologic
Pulmonary
No symptomatic pulmonary disease requiring medication including the following:
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
United States, District of Columbia | |
Howard University Cancer Center | |
Washington, District of Columbia, United States, 20060 | |
United States, Florida | |
Mayo Clinic - Jacksonville | |
Jacksonville, Florida, United States, 32224 | |
United States, Maryland | |
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | |
Baltimore, Maryland, United States, 21231 | |
United States, Michigan | |
Barbara Ann Karmanos Cancer Institute | |
Detroit, Michigan, United States, 48201-1379 | |
United States, Minnesota | |
Mayo Clinic Cancer Center | |
Rochester, Minnesota, United States, 55905 | |
United States, Missouri | |
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis | |
Saint Louis, Missouri, United States, 63110 | |
United States, Ohio | |
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center | |
Columbus, Ohio, United States, 43210-1240 | |
United States, Wisconsin | |
University of Wisconsin Paul P. Carbone Comprehensive Cancer Center | |
Madison, Wisconsin, United States, 53792-6164 | |
China | |
Prince of Wales Hospital | |
Hong Kong, China | |
Singapore | |
Cancer Institute at National University Hospital | |
Singapore, Singapore, 119074 | |
Johns Hopkins Singapore International Medical Centre | |
Singapore, Singapore, 308433 | |
National Cancer Centre - Singapore | |
Singapore, Singapore, 169610 |
Study Chair: | Jeffrey F. Moley, MD | Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis |
Investigator: | Robert C. Smallridge, MD | Mayo Clinic |
Responsible Party: | Mayo Clinic Cancer Center ( Charles Erlichman ) |
Study ID Numbers: | CDR0000433150, MAYO-MC0476, NCI-6482, JHOC-JS0652, JHOC-B/06/174 |
Study First Received: | July 8, 2005 |
Last Updated: | June 26, 2009 |
ClinicalTrials.gov Identifier: | NCT00118248 History of Changes |
Health Authority: | United States: Federal Government |
stage IV papillary thyroid cancer stage IV follicular thyroid cancer thyroid gland medullary carcinoma recurrent thyroid cancer |
Adenocarcinoma, Follicular Carcinoma, Medullary Thyroid Neoplasms Thyroid Cancer, Papillary Thyroid Cancer, Medullary Endocrine System Diseases Recurrence |
Carcinoma Thyroid Cancer, Follicular Head and Neck Neoplasms Endocrinopathy Thyroid Diseases Endocrine Gland Neoplasms |
Neoplasms Neoplasms by Site Thyroid Neoplasms Head and Neck Neoplasms |
Endocrine System Diseases Thyroid Diseases Endocrine Gland Neoplasms |