FR901228 in Treating Patients With Unresectable Stage III or Stage IV Malignant Melanoma

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2006 by Eastern Cooperative Oncology Group.
Recruitment status was  Active, not recruiting
National Cancer Institute (NCI)
Information provided by:
Eastern Cooperative Oncology Group Identifier:
First received: March 3, 2005
Last updated: March 8, 2012
Last verified: June 2006

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 unresectable stage III or stage IV malignant melanoma.

Condition Intervention Phase
Intraocular Melanoma
Melanoma (Skin)
Drug: romidepsin
Phase 2

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Trial of Depsipeptide (NSC 630176) in Advanced Malignant Melanoma

Resource links provided by NLM:

Further study details as provided by Eastern Cooperative Oncology Group:

Primary Outcome Measures:
  • Response rate [ Designated as safety issue: No ]
  • Progression-free and overall survival [ Designated as safety issue: No ]
  • Toxicity [ Designated as safety issue: Yes ]

Study Start Date: January 2005
Estimated Primary Completion Date: August 2006 (Final data collection date for primary outcome measure)
Detailed Description:



  • Determine the response rate in patients with unresectable stage III or stage IV malignant melanoma treated with FR901228 (depsipeptide).


  • Determine the progression-free and overall survival of patients treated with this drug.
  • Determine the toxicity profile 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.

After completion of study treatment, patients are followed every 3 months for 1 year and then every 6 months for 2 years.

PROJECTED ACCRUAL: A total of 22-40 patients will be accrued for this study within 18 months.


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


  • Diagnosis of malignant melanoma meeting 1 of the following stage criteria:

    • Unresectable stage III disease
    • Stage IV disease
  • The following melanoma types are allowed:

    • Cutaneous
    • Mucosal
    • Ocular
    • Unknown primary
  • Measurable disease by physical examination or imaging studies

    • Lesions on bone scan and positron-emission tomography are not considered measurable
    • Measurable disease must be outside a previously irradiated port
  • Palpable cutaneous or nodal metastases suitable for punch, trucut, or similar biopsy
  • No active CNS metastases by brain CT scan or MRI (performed < 4 weeks before study entry)

    • Solitary CNS lesions treated with surgery or stereotactic radiosurgery/gamma knife are allowed provided disease has been stable AND there is no evidence of new CNS lesions within the past 3 months



  • 18 and over

Performance status

  • ECOG 0-2

Life expectancy

  • Not specified


  • WBC ≥ 3,000/mm^3
  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Hemoglobin ≥ 9 g/dL


  • AST and/or ALT ≤ 2.5 times upper limit of normal
  • Bilirubin normal


  • Creatinine normal OR
  • Creatinine clearance ≥ 60 mL/min


  • No history of coronary atherosclerotic heart disease
  • No history of myocardial infarction
  • No history of congestive heart failure
  • EKG normal
  • LVEF > 40% by MUGA
  • QTc < 500 msec
  • No history of serious ventricular arrhythmia (e.g., ventricular tachycardia or ventricular fibrillation ≥ 3 beats in a row)
  • Cardiac hypertrophy allowed

    • No left ventricular hypertrophy by EKG


  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • Potassium ≥ 4.0 mmol/L
  • Magnesium ≥ 2 mg/dL
  • No nonmelanoma malignancy within the past 5 years except carcinoma in situ or squamous cell or basal cell skin cancer
  • No history of 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 uncontrolled illness
  • No other condition that would preclude study participation


Biologic therapy

  • At least 4 weeks since prior immunotherapy, including any of the following:

    • Interferon
    • Interleukin
    • Sargramostim (GM-CSF)
    • Vaccines
  • No concurrent biologic agents except filgrastim (G-CSF)


  • No prior FR901228 (depsipeptide)
  • No prior chemotherapy
  • No other concurrent chemotherapy

Endocrine therapy

  • Not specified


  • See Disease Characteristics
  • Prior whole brain radiotherapy allowed
  • At least 4 weeks since prior radiotherapy
  • No concurrent radiotherapy


  • See Disease Characteristics
  • No prior coronary artery bypass graft or stent


  • At least 5 half-lives since prior and no concurrent agents that may cause QTc prolongation
  • No other concurrent investigational agents
  • No other concurrent antineoplastic agents
  • No other concurrent drugs known to have histone deacetylase inhibitor activity (e.g., sodium valproate)
  • No concurrent combination antiretroviral therapy for HIV-positive patients
  • No concurrent hydrochlorothiazide
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00104884

Sponsors and Collaborators
Eastern Cooperative Oncology Group
National Cancer Institute (NCI)
Study Chair: David H. Lawson, MD Winship Cancer Institute of Emory University
Investigator: Sanjiv S. Agarwala, MD University of Pittsburgh
  More Information

No publications provided

Responsible Party: Group Chair, Eastern Cooperative Oncology Group Identifier: NCT00104884     History of Changes
Other Study ID Numbers: CDR0000415355  U10CA021115  ECOG-E1603 
Study First Received: March 3, 2005
Last Updated: March 8, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Eastern Cooperative Oncology Group:
stage III melanoma
stage IV melanoma
recurrent melanoma
iris melanoma
recurrent intraocular melanoma
extraocular extension melanoma
ciliary body and choroid melanoma, medium/large size

Additional relevant MeSH terms:
Uveal Neoplasms
Eye Diseases
Eye Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Neuroectodermal Tumors
Neuroendocrine Tumors
Nevi and Melanomas
Uveal Diseases processed this record on February 11, 2016