Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsors and Collaborators: |
Arthur G. James Cancer Hospital & Richard J. Solove Research Institute National Cancer Institute (NCI) |
---|---|
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00084461 |
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 II trial to study the effectiveness of FR901228 in treating patients who have locally advanced or metastatic neuroendocrine tumors.
Condition | Intervention | Phase |
---|---|---|
Gastrointestinal Carcinoid Tumor Islet Cell Tumor Lung Cancer Neoplastic Syndrome |
Drug: romidepsin |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | Phase II Study of Depsipeptide in Metastatic Neuroendocrine Tumors |
Study Start Date: | March 2004 |
OBJECTIVES:
Primary
Secondary
OUTLINE: Patients receive FR901228 (depsipeptide) IV over 4 hours on days 1, 8, and 15. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients achieving complete remission (CR) receive 2 additional courses beyond CR.
Patients are followed at 2-4 weeks.
PROJECTED ACCRUAL: A total of 16-25 patients will be accrued for this study within 4-6 months.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed carcinoid tumor or islet cell neuroendocrine tumor
Measurable disease
No truly non-measurable lesions, including the following:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Concurrent long-acting octreotide allowed at standard doses if dose has been stable for the past 12 weeks
Radiotherapy
Surgery
Other
United States, Ohio | |
Arthur G. James Cancer Hospital at Ohio State University | |
Columbus, Ohio, United States, 43210-1240 |
Principal Investigator: | Manisha H. Shah, MD | Arthur G. James Cancer Hospital & Richard J. Solove Research Institute |
Study ID Numbers: | CDR0000365313, OSU-2003C0085, NCI-6325 |
Study First Received: | June 10, 2004 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00084461 |
Health Authority: | United States: Federal Government |
gastrinoma insulinoma somatostatinoma glucagonoma pancreatic polypeptide tumor recurrent islet cell carcinoma |
pulmonary carcinoid tumor WDHA syndrome metastatic gastrointestinal carcinoid tumor recurrent gastrointestinal carcinoid tumor regional gastrointestinal carcinoid tumor |
Thoracic Neoplasms Gastrointestinal Diseases Pancreatic Neoplasms Pancreatic Polypeptide Respiratory Tract Diseases Lung Neoplasms Neoplasms, Germ Cell and Embryonal Neuroepithelioma Endocrine Gland Neoplasms Digestive System Neoplasms Carcinoma, Islet Cell Serotonin Syndrome Insulinoma Romidepsin Endocrine System Diseases |
Adenoma, Islet Cell Malignant Carcinoid Syndrome Carcinoid syndrome Recurrence Neuroendocrine Tumors Carcinoma Carcinoid tumor Neuroectodermal Tumors Gastrinoma Digestive System Diseases Lung Diseases Pancreatic Diseases Gastrointestinal Neoplasms Carcinoid Tumor Endocrinopathy |
Respiratory Tract Neoplasms Neoplasms Pathologic Processes Disease Neoplasms by Site Neoplasms by Histologic Type |
Antineoplastic Agents Therapeutic Uses Syndrome Neoplasms, Nerve Tissue Antibiotics, Antineoplastic Pharmacologic Actions |