FR901228 in Treating Patients With Unresectable Stage III or Stage IV Malignant Melanoma
This trial is active, not recruiting.
|Conditions||intraocular melanoma, melanoma (skin)|
|Sponsor||Eastern Cooperative Oncology Group|
|Collaborator||National Cancer Institute (NCI)|
|Start date||January 2005|
|End date||August 2006|
|Trial identifier||NCT00104884, CDR0000415355, ECOG-E1603, U10CA021115|
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.
Progression-free and overall survival
Male or female participants at least 18 years old.
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
|Official title||Phase II Trial of Depsipeptide (NSC 630176) in Advanced Malignant Melanoma|
|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.|
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