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FR901228 in Treating Patients With T-Cell Lymphoma
This study is ongoing, but not recruiting participants.
First Received: July 11, 2001   Last Updated: June 10, 2009   History of Changes
Sponsor: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00020436
  Purpose

RATIONALE: Drugs used in chemotherapy work in different ways to stop cancer cells from dividing so they stop growing or die.

PURPOSE: This phase II trial is studying how well FR901228 works in treating patients with T-cell lymphoma.


Condition Intervention Phase
Lymphoma
Drug: romidepsin
Phase II

Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: Phase II Trial Of Depsipeptide In Patients With Cutaneous T-Cell Lymphoma And Relapsed Peripheral T-Cell Lymphoma

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Overall response rate [ Designated as safety issue: No ]
  • Complete response rate [ Designated as safety issue: No ]
  • Duration of response [ Designated as safety issue: No ]

Estimated Enrollment: 197
Study Start Date: December 2000
Estimated Primary Completion Date: April 2001 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

Primary

  • Determine the overall and complete response rates in patients with cutaneous T-cell lymphoma (CTCL), relapsed peripheral T-cell lymphoma, or other mature T-cell lymphoma treated with FR901228 (depsipeptide).
  • Determine the duration of response in patients with CTCL treated with this drug.

Secondary

  • Determine the tolerability of this drug with extended courses of therapy in these patients.
  • Determine the molecular 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.

PROJECTED ACCRUAL: A total of 197 patients will be accrued for this study.

  Eligibility

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

DISEASE CHARACTERISTICS:

  • One of the following diagnoses:

    • Histologically confirmed cutaneous T-cell lymphoma (CTCL) (mycosis fungoides or Sezary syndrome)

      • Stage IB or IIA

        • Refractory to, intolerant of, or at a 6-month or longer response plateau on at least 2 of the following prior therapies:

          • Phototherapy (psoralen ultraviolet light, ultraviolet B light, or EBT), photophoresis, interferon, systemic cytotoxic chemotherapy, topical nitrogen mustard, or topical carmustine
          • One prior therapy must have been phototherapy, topical nitrogen mustard, or topical carmustine
          • Topical steroids, systemic retinoids, and biologicals do not qualify
      • Stage IIB-IVB

        • CTCL previously treated with vorinostat
    • Peripheral T-cell lymphoma, unspecified or anaplastic large cell lymphoma, T and null cell, primary cutaneous type*
    • Other mature T-cell lymphoma* not listed above including, but not limited to:

      • Enteropathy-type T-cell lymphoma
      • Hepatosplenic T-cell lymphoma
      • Subcutaneous panniculitis-like T-cell lymphoma
      • Angioimmunoblastic T-cell lymphoma
  • No primitive T-cell neoplasm or T-cell leukemia
  • Measurable disease by radiographic imaging, assessment of skin lesions, or quantitating Sezary cell count
  • No B-cell lymphoma
  • No known CNS lymphoma NOTE: *Disease progression after prior standard therapy (> 2 prior systemic cytotoxic chemotherapy regimens)

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • ECOG 0-2

Life expectancy:

  • More than 12 weeks

Hematopoietic:

  • Absolute neutrophil count at least 1,000/mm^3*
  • Platelet count at least 100,000/mm^3* NOTE: *Unless decreased levels are due to bone marrow involvement by lymphoma

Hepatic:

  • Bilirubin no greater than 1.5 times upper limit of normal (ULN)*
  • AST no greater than 3 times ULN* NOTE: *Unless elevated levels are due to liver involvement by lymphoma

Renal:

  • Creatinine no greater than 1.5 times ULN OR
  • Creatinine clearance at least 60 mL/min

Cardiovascular:

  • No myocardial infarction within the past 12 months
  • No active coronary artery disease (e.g., angina, defined by Canadian Class II-IV)
  • No congenital long QT syndrome
  • QTc ≤ 480 msec
  • No cardiac ischemia (ST depression ≥ 2 mm) by ECG
  • No Mobitz II second-degree heart block without a pacemaker
  • Cardiology consultation and/or Holter monitoring required for any 1 of the following:

    • Coronary artery disease (no active myocardial ischemia)
    • History of arrhythmia
    • First-degree or Mobitz I second-degree heart block
    • Bradyarrhythmia
    • Sick sinus syndrome
  • No New York Heart Association class II-IV congestive heart failure
  • Ejection fraction ≥ 50% by echocardiogram or cardiac MRI OR ≥ 45% by MUGA scan
  • No history of sustained ventricular tachycardia, ventricular fibrillation, Torsade de Pointes, or cardiac arrest unless supported by an automatic implantable cardioverter defibrillator (AICD)
  • No dilated, hypertrophic, or restrictive cardiomyopathy from prior treatment or other causes
  • No uncontrolled hypertension (i.e., blood pressure ≥ 160/95 mmHg)
  • No cardiac arrhythmia requiring anti-arrhythmic medication

    • Beta blockers or calcium channel blockers allowed
    • Must discontinue digitalis therapy
  • Other cardiac disease may be excluded at the discretion of the protocol investigator and cardiologist

Other:

  • HIV negative
  • No other serious or concurrent illness
  • No uncontrolled infection
  • No uncontrolled medical illness
  • No prior or concurrent malignancy not curatively treated
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 2 months after study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • See Disease Characteristics
  • More than 2 weeks since prior biologic or immunotherapy

Chemotherapy:

  • See Disease Characteristics
  • At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin)
  • No more than 2 prior systemic cytotoxic chemotherapy regimens (for patients with cutaneous T-cell lymphoma)

    • Radiolabeled monoclonal antibody therapy is counted toward the prior regimens
    • No limit on prior regimens for patients with other mature T-cell lymphoma
  • No other concurrent chemotherapy, including topical agents

Endocrine therapy:

  • See Disease Characteristics
  • Concurrent corticosteroids for symptom management allowed provided dose is stable for more than 1 month

Radiotherapy:

  • Prior localized external-beam radiotherapy allowed
  • Concurrent localized external-beam radiotherapy for palliation of metastatic disease allowed if evidence of response to study drug
  • No concurrent localized external-beam radiotherapy for disease progression

Surgery:

  • At least 3 weeks since prior major surgery
  • Concurrent surgery for palliation of metastatic disease allowed if evidence of response to study drug
  • No concurrent surgery for disease progression

Other:

  • Prior complementary and alternative medications allowed
  • No concurrent complementary and alternative medications
  • No concurrent medications that prolong the QTc interval

    • At least 5 half-lives after administration of medications that prolong the QTc interval
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00020436

Locations
United States, Arizona
Mayo Clinic Scottsdale
Scottsdale, Arizona, United States, 85259
United States, Arkansas
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
United States, California
City of Hope Comprehensive Cancer Center
Duarte, California, United States, 91010-3000
Sierra Hematology Oncology Medical Center - Sacramento
Sacremento, California, United States, 95819
United States, District of Columbia
Lombardi Comprehensive Cancer Center at Georgetown University Medical Center
Washington, District of Columbia, United States, 20007
United States, Illinois
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago, Illinois, United States, 60611
United States, Maryland
NCI - Center for Cancer Research
Bethesda, Maryland, United States, 20892
Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office
Bethesda, Maryland, United States, 20892-1182
United States, Massachusetts
Boston University Cancer Research Center
Boston, Massachusetts, United States, 02118
United States, New York
Don Monti Comprehensive Cancer Center at North Shore University Hospital
Manhasset, New York, United States, 11030
Mount Sinai Medical Center
New York, New York, United States, 10029
NYU Cancer Institute at New York University Medical Center
New York, New York, United States, 10016
United States, North Carolina
Duke Comprehensive Cancer Center
Durham, North Carolina, United States, 27710
United States, Pennsylvania
UPMC Cancer Centers
Pittsburgh, Pennsylvania, United States, 15232
United States, Texas
M. D. Anderson Cancer Center at University of Texas
Houston, Texas, United States, 77030-4009
Australia, South Australia
Institute of Medical and Veterinary Science
Adelaide, South Australia, Australia, 5000
Australia, Victoria
Peter MacCallum Cancer Centre
East Melbourne, Victoria, Australia, 8006
Australia, Western Australia
Sir Charles Gairdner Hospital - Perth
Perth, Western Australia, Australia, 6009
Sponsors and Collaborators
Investigators
Study Chair: Richard Piekarz, MD, PhD National Cancer Institute (NCI)
  More Information

Additional Information:
Publications:
Responsible Party: University of Chicago Cancer Research Center ( Everett E. Vokes )
Study ID Numbers: CDR0000068466, NCI-01-C-0049, NCI-1312
Study First Received: July 11, 2001
Last Updated: June 10, 2009
ClinicalTrials.gov Identifier: NCT00020436     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by National Cancer Institute (NCI):
stage II cutaneous T-cell non-Hodgkin lymphoma
stage III cutaneous T-cell non-Hodgkin lymphoma
stage IV cutaneous T-cell non-Hodgkin lymphoma
recurrent cutaneous T-cell non-Hodgkin lymphoma
anaplastic large cell lymphoma
stage II mycosis fungoides/Sezary syndrome
stage III mycosis fungoides/Sezary syndrome
stage IV mycosis fungoides/Sezary syndrome
recurrent mycosis fungoides/Sezary syndrome
recurrent adult diffuse large cell lymphoma
recurrent adult immunoblastic large cell lymphoma

Additional relevant MeSH terms:
Neoplasms by Histologic Type
Immunoproliferative Disorders
Immune System Diseases
Antineoplastic Agents
Romidepsin
Antibiotics, Antineoplastic
Lymphoma, T-Cell, Peripheral
Pharmacologic Actions
Lymphatic Diseases
Neoplasms
Therapeutic Uses
Lymphoma, T-Cell
Lymphoproliferative Disorders
Lymphoma, Non-Hodgkin
Lymphoma
Lymphoma, T-Cell, Cutaneous

ClinicalTrials.gov processed this record on November 27, 2009