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FR901228 in Treating Patients With Relapsed or Refractory Multiple Myeloma
The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2006 by National Cancer Institute (NCI).   Recruitment status was  Active, not recruiting

First Received on August 6, 2003.   Last Updated on November 16, 2008   History of Changes
Sponsor: Albert Einstein College of Medicine of Yeshiva University
Collaborator: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00066638
  Purpose

RATIONALE: Drugs used in chemotherapy such as FR901228 use different ways to stop cancer cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of FR901228 in treating patients who have relapsed or refractory multiple myeloma.


Condition Intervention Phase
Multiple Myeloma and Plasma Cell Neoplasm
Drug: romidepsin
Phase II

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study Of Depsipeptide (NSC 630176; IND #51, 810) In Relapsed/Refractory Multiple Myeloma

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Response rate (complete and partial) [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Event-free survival [ Designated as safety issue: No ]
  • Response duration [ Designated as safety issue: No ]
  • Median time to progression [ Designated as safety issue: No ]
  • Rate and duration of stable disease [ Designated as safety issue: No ]
  • Gene array and immunochemistry parameters [ Designated as safety issue: No ]
  • Comparison of patterns of gene and phenotype expression at baseline and after completion of study treatment [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: October 2003
Detailed Description:

OBJECTIVES:

  • Determine the safety and efficacy of FR901228 (depsipeptide) in patients with relapsed or refractory multiple myeloma.

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 who achieve a stable plateau (stable paraprotein levels or urine protein excretion over 3 consecutive determinations at least 4 weeks apart) may receive maintenance therapy comprising FR901228 IV on days 1 and 15, with courses repeating every 28 days.

PROJECTED ACCRUAL: A total of 21-50 patients will be accrued for this study within 5-12.5 months.

  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 multiple myeloma

    • Stage IIa or IIIa
    • Progressive disease after 1-4 prior lines of therapy
  • Measurable disease, defined by 1 of the following:

    • Serum M protein at least 1.0 g/dL by protein electrophoresis or free light chain measurement
    • Quantitative immunoglobulins and/or urinary M protein excretion at least 200 mg/24 hours
  • No known neoplastic CNS abnormality
  • No non-secretory disease or plasma cell leukemia (circulating plasma cells greater than 2,000/mm^3)

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • Karnofsky 70-100%

    • Karnofsky 60% allowed if reduced status is due to advanced skeletal disease

Life expectancy

  • More than 12 weeks

Hematopoietic

  • WBC at least 3,000/mm^3
  • Absolute neutrophil count (ANC) at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3
  • Cytopenias due to myeloma marrow infiltration are allowed provided all of the following are true:

    • Bone marrow biopsy displays at least normal cellularity for age and at least 50% involvement by myeloma
    • ANC greater than 1,000/mm^3
    • Platelet count greater than 50,000/mm^3

Hepatic

  • Bilirubin less than 2.0 mg/dL
  • SGOT and SGPT no greater than 2.5 times upper limit of normal

Renal

  • Creatinine no greater than 1.5 mg/dL OR
  • Creatinine clearance at least 60 mL/min

Cardiovascular

  • No left ventricular hypertrophy
  • No cardiac arrhythmias, including atrial fibrillation
  • No myocardial infarction
  • No symptomatic congestive heart failure
  • No unstable angina pectoris
  • Ejection fraction at least 50%
  • EKG normal

Other

  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • HIV negative
  • No known inflammatory, vascular, or degenerative CNS abnormality
  • No epilepsy
  • No history of allergic reaction attributed to compounds of similar chemical or biological composition to FR901228
  • No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
  • No ongoing or active infection
  • No psychiatric illness or social situation that would preclude study compliance
  • No other concurrent illness that would preclude study compliance

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered
  • No prior histone deacetylase inhibitors

Endocrine therapy

  • No concurrent initiation of corticosteroid therapy for myeloma

Radiotherapy

  • More than 4 weeks since prior radiotherapy and recovered
  • No concurrent localized external beam radiotherapy

Surgery

  • No concurrent surgery

Other

  • No other concurrent investigational agent
  • No concurrent hydrochlorothiazides
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00066638

Locations
United States, New York
Albert Einstein Cancer Center at Albert Einstein College of Medicine
Bronx, New York, United States, 10461
Mount Sinai Medical Center
New York, New York, United States, 10029
New York Weill Cornell Cancer Center at Cornell University
New York, New York, United States, 10021
Sponsors and Collaborators
Albert Einstein College of Medicine of Yeshiva University
Investigators
Principal Investigator: Ruben Niesvizky, MD Weill Medical College of Cornell University
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00066638     History of Changes
Other Study ID Numbers: CDR0000316449, AECM-0403765, NCI-5996
Study First Received: August 6, 2003
Last Updated: November 16, 2008
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage II multiple myeloma
stage III multiple myeloma
refractory multiple myeloma

Additional relevant MeSH terms:
Neoplasms
Multiple Myeloma
Neoplasms, Plasma Cell
Plasmacytoma
Neoplasms by Histologic Type
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Romidepsin
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 12, 2012