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
Sponsor:
Collaborator:
Information provided by:
Eastern Cooperative Oncology Group
ClinicalTrials.gov Identifier:
NCT00104884
First received: March 3, 2005
Last updated: March 8, 2012
Last verified: June 2006
  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 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:

OBJECTIVES:

Primary

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

Secondary

  • 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.

  Eligibility

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

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • ECOG 0-2

Life expectancy

  • Not specified

Hematopoietic

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

Hepatic

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

Renal

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

Cardiovascular

  • 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

Other

  • 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

PRIOR CONCURRENT THERAPY:

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)

Chemotherapy

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

Endocrine therapy

  • Not specified

Radiotherapy

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

Surgery

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

Other

  • 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00104884

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

Additional Information:
No publications provided

Responsible Party: Group Chair, Eastern Cooperative Oncology Group
ClinicalTrials.gov 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:
Melanoma
Uveal Neoplasms
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Eye Neoplasms
Neoplasms by Site
Eye Diseases
Uveal Diseases
Romidepsin
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 15, 2014