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FR901228 in Treating Patients With Metastatic or Unresectable Soft Tissue Sarcoma
The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2009 by National Cancer Institute (NCI).   Recruitment status was  Active, not recruiting

First Received on June 2, 2005.   Last Updated on April 14, 2009   History of Changes
Sponsor: Wake Forest University
Collaborator: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00112463
  Purpose

RATIONALE: Drugs used in chemotherapy, such as FR901228, 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 FR901228 works in treating patients with metastatic or unresectable soft tissue sarcoma.


Condition Intervention Phase
Gastrointestinal Stromal Tumor
Sarcoma
Drug: romidepsin
Phase II

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study of Single Agent Depsipeptide (FK228) in Metastatic or Unresectable Soft Tissue Sarcomas

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Objective tumor response (complete and partial) [ Designated as safety issue: No ]
  • Toxicity [ Designated as safety issue: Yes ]
  • Time to progression [ Designated as safety issue: No ]

Estimated Enrollment: 36
Study Start Date: January 2005
Estimated Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

  • Determine the response rate in patients with metastatic or unresectable soft tissue sarcoma treated with FR901228(depsipeptide).
  • Determine the time to progression in patients treated with this drug.
  • Determine the scope and extent of acute toxic effects of this drug in these patients.

OUTLINE: This is a multicenter study.

Patients receive FR901228 (depsipeptide) IV over 4 hours on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) receive 6 additional courses beyond documentation of CR.

After completion of study treatment, patients are followed every 2 months.

PROJECTED ACCRUAL: A total of 18-36 patients will be accrued for this study within approximately 1 year.

  Eligibility

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

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed soft tissue sarcoma (STS), including, but not limited to, the following histologies:

    • Gastrointestinal stromal tumors (GIST)

      • Refractory to imatinib mesylate
    • Desmoplastic small round cell tumors
    • Clear cell sarcoma
    • Extraskeletal osteosarcoma*
    • Extraskeletal Ewing's sarcoma*
    • Extraskeletal (myxoid) chondrosarcoma* NOTE: *Histologies typically associated with osseous primaries allowed provided the primary is extraskeletal
  • Secondary STS (e.g., radiation-induced STS or neurofibrosarcoma due to neurofibromatosis) allowed
  • Metastatic or unresectable disease
  • No standard curative therapy exists
  • Patients with GIST must have received and progressed on imatinib mesylate
  • Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan
  • No known brain metastases

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • ECOG 0-2 OR
  • Karnofsky 50-100%

Life expectancy

  • More than 3 months

Hematopoietic

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

Hepatic

  • AST and ALT ≤ 2.5 times upper limit of normal (ULN)
  • Bilirubin normal

Renal

  • Creatinine < 1.5 times ULN OR
  • Creatinine clearance ≥ 60 mL/min

Cardiovascular

  • QTc ≤ 480 msec
  • No cardiac abnormalities (e.g., congenital long QT syndrome)
  • No myocardial infarction within the past year
  • No history of coronary artery disease (e.g., angina Canadian Class II-IV or positive stress imaging study)
  • No cardiac ischemia (ST depression >2 mm) by ECG
  • No New York Heart Association Class II-IV congestive heart failure
  • Ejection fraction > 50% by MUGA scan or echocardiogram
  • No history of sustained ventricular tachycardia, ventricular fibrillation, Torsades de Pointes, or cardiac arrest unless controlled by an automatic implantable cardioverter defibrillator
  • No hypertrophic or restrictive cardiomyopathy from prior treatment or other causes
  • No significant left ventricular hypertrophy
  • No uncontrolled hypertension (i.e., blood pressure ≥ 160/95 mm Hg)
  • No cardiac arrhythmia requiring anti-arrhythmic medication

    • Beta blocker or calcium channel blocker allowed
    • Patients on digitalis that cannot be discontinued not allowed
  • No Mobitz II second degree block without a pacemaker (first degree or Mobitz I second degree block, bradyarrhythmias, or sick sinus syndrome require Holter monitoring and evaluation by cardiology)
  • No uncontrolled dysrhythmia
  • No poorly controlled angina
  • No other cardiac disease

Immunologic

  • No history of allergic reaction attributed to compounds of similar chemical or biological composition to FR901228
  • No ongoing or active infection
  • No iatrogenic immune deficiency or immune deficiency secondary to an underlying disorder

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • Potassium ≥ 4.0 mmol/L
  • Magnesium ≥ 2.0 mg/dL
  • No other uncontrolled illness
  • No psychiatric illness or social situation that would preclude study compliance

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • No concurrent anticancer biologic agents

Chemotherapy

  • No more than 1 prior chemotherapy regimen for sarcoma

    • Adjuvant chemotherapy preceding disease relapse is considered 1 prior chemotherapy regimen
    • Patients with GIST may have received up to 3 prior chemotherapy regimens comprising imatinib mesylate and/or sunitinib malate provided no other chemotherapy agents were used
  • No prior FR901228 (depsipeptide)
  • At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin)
  • No prior cumulative doxorubicin dose > 500 mg/m^2
  • No other concurrent anticancer chemotherapy

Endocrine therapy

  • Not specified

Radiotherapy

  • At least 4 weeks since prior radiotherapy
  • No concurrent anticancer radiotherapy

Surgery

  • At least 4 weeks since prior surgery
  • No prior organ transplantation

Other

  • Recovered from all prior therapy
  • No concurrent medications that cause QTc prolongation
  • No concurrent combination highly active anti-retroviral therapy for HIV-positive patients
  • No other concurrent drugs known to have histone deacetylase inhibitor activity (e.g., sodium valproate)
  • No other concurrent investigational agents
  • No other concurrent anticancer agents
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00112463

Locations
United States, Arizona
CCOP - Western Regional, Arizona
Phoenix, Arizona, United States, 85006-2726
United States, California
CCOP - Bay Area Tumor Institute
Oakland, California, United States, 94609-3305
United States, Georgia
Harbin Clinic Cancer Services
Rome, Georgia, United States, 30165
United States, Illinois
CCOP - Central Illinois
Decatur, Illinois, United States, 62526
United States, North Carolina
Alamance Cancer Center at Alamance Regional Medical Center
Burlington, North Carolina, United States, 27216
Hugh Chatham Memorial Hospital
Elkin, North Carolina, United States, 28621
CCOP - Southeast Cancer Control Consortium
Goldsboro, North Carolina, United States, 27534-9479
Southeastern Medical Oncology Center - Goldsboro
Goldsboro, North Carolina, United States, 27534
Brody School of Medicine at East Carolina University
Greenville, North Carolina, United States, 27858
High Point Regional Hospital
High Point, North Carolina, United States, 27261
Wake Forest University Comprehensive Cancer Center
Winston-Salem, North Carolina, United States, 27157-1096
United States, Ohio
CCOP - Columbus
Columbus, Ohio, United States, 43215
United States, South Carolina
CCOP - Greenville
Greenville, South Carolina, United States, 29615
CCOP - Upstate Carolina
Spartanburg, South Carolina, United States, 29303
United States, Virginia
Cancer Center of the Piedmont
Danville, Virginia, United States, 24541
Danville Hematology and Oncology, Incorporated
Danville, Virginia, United States, 24541
Sponsors and Collaborators
Wake Forest University
Investigators
Study Chair: Paul D. Savage, MD Comprehensive Cancer Center of Wake Forest University
  More Information

Additional Information:
No publications provided

Responsible Party: Edward Newman, California Cancer Consortium
ClinicalTrials.gov Identifier: NCT00112463     History of Changes
Other Study ID Numbers: CDR0000433042, CCCWFU-71103
Study First Received: June 2, 2005
Last Updated: April 14, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by National Cancer Institute (NCI):
recurrent adult soft tissue sarcoma
stage III adult soft tissue sarcoma
stage IV adult soft tissue sarcoma
gastrointestinal stromal tumor
adult alveolar soft-part sarcoma
adult angiosarcoma
adult epithelioid sarcoma
adult extraskeletal chondrosarcoma
adult extraskeletal osteosarcoma
adult fibrosarcoma
adult leiomyosarcoma
adult liposarcoma
adult malignant fibrous histiocytoma
adult malignant hemangiopericytoma
adult malignant mesenchymoma
adult neurofibrosarcoma
adult rhabdomyosarcoma
adult synovial sarcoma
metastatic Ewing sarcoma/peripheral primitive neuroectodermal tumor
recurrent Ewing sarcoma/peripheral primitive neuroectodermal tumor

Additional relevant MeSH terms:
Gastrointestinal Stromal Tumors
Neuroectodermal Tumors, Primitive, Peripheral
Sarcoma
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Neuroectodermal Tumors, Primitive
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Neoplasms, Connective and Soft Tissue
Romidepsin
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2012