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FR901228 in Treating Patients With Locally Advanced or Metastatic Neuroendocrine Tumors
This study is ongoing, but not recruiting participants.
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
  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 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

MedlinePlus related topics: Cancer Carcinoid Tumors Lung Cancer
Drug Information available for: FR 901228
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: Phase II Study of Depsipeptide in Metastatic Neuroendocrine Tumors

Further study details as provided by National Cancer Institute (NCI):

Study Start Date: March 2004
Detailed Description:

OBJECTIVES:

Primary

  • Determine objective response rate in patients with locally advanced or metastatic neuroendocrine tumors treated with FR901288 (depsipeptide).

Secondary

  • Determine the toxicity of this drug in these patients.
  • Correlate histone acetylation assay results with disease response and immunologic parameters in patients treated with this drug.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed carcinoid tumor or islet cell neuroendocrine tumor

    • Well- or moderately-differentiated tumor
  • Metastatic and/or locally advanced disease
  • Measurable disease

    • Unidimensionally measurable lesion at least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan
    • Lesions in a previously irradiated area are not considered measurable
    • No truly non-measurable lesions, including the following:

      • Bone lesions
      • Leptomeningeal disease
      • Ascites
      • Pleural or pericardial effusion
      • Lymphangitis cutis/pulmonis
      • Abdominal masses not confirmed and followed by imaging
      • Cystic lesions
  • Ineligible for standard treatment

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • ECOG 0-1

Life expectancy

  • At least 6 months

Hematopoietic

  • WBC ≥ 3,000/mm^3
  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3

Hepatic

  • Bilirubin ≤ 1.5 mg/dL
  • AST and ALT ≤ 2.5 times upper limit of normal

Renal

  • Creatinine ≤ 1.5 mg/dL

Cardiovascular

  • No New York Heart Association class III or IV congestive heart failure
  • No myocardial infarction within the past year
  • No uncontrolled dysrhythmias
  • No poorly controlled angina
  • No serious ventricular arrhythmia, defined as ventricular tachycardia or ventricular fibrillation ≥ 3 beats in a row
  • No left ventricular hypertrophy by EKG
  • No other significant cardiac disease
  • QTc < 500 msec
  • LVEF > 40% by resting MUGA

Other

  • No prior allergic reaction attributed to compounds of similar chemical or biological composition to study drug
  • No ongoing or active infection
  • No psychiatric illness or social situation that would preclude study compliance
  • No other concurrent uncontrolled illness
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • More than 4 weeks since prior immunotherapy (e.g., interferon alfa)

Chemotherapy

  • More than 4 weeks since prior chemotherapy
  • More than 12 weeks since prior hepatic artery chemoembolization unless liver lesions are not the only indicator lesions
  • No prior FR901228 (depsipeptide)
  • No more than 1 prior systemic chemotherapy regimen for carcinoid or islet cell tumor (other than hepatic artery chemoembolization)

Endocrine therapy

  • More than 4 weeks since prior oral or IV steroids (first 16 patients only)
  • Concurrent long-acting octreotide allowed at standard doses if dose has been stable for the past 12 weeks

    • Concurrent subcutaneous octreotide for breakthrough use for symptomatic relief allowed
  • No concurrent systemic steroids (first 16 patients only)

Radiotherapy

  • See Disease Characteristics
  • More than 4 weeks since prior radiotherapy

Surgery

  • Not specified

Other

  • More than 4 weeks since prior investigational tumor-specific therapy
  • No other prior histone deacetylase inhibitors (e.g., valproic acid)
  • No concurrent hydrochlorothiazide
  • No concurrent combination antiretroviral therapy for HIV-positive patients
  • No other concurrent investigational or commercial agents or therapies for the malignancy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00084461

Locations
United States, Ohio
Arthur G. James Cancer Hospital at Ohio State University
Columbus, Ohio, United States, 43210-1240
Sponsors and Collaborators
Arthur G. James Cancer Hospital & Richard J. Solove Research Institute
Investigators
Principal Investigator: Manisha H. Shah, MD Arthur G. James Cancer Hospital & Richard J. Solove Research Institute
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

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

Keywords provided by National Cancer Institute (NCI):
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

Study placed in the following topic categories:
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

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on January 16, 2009