Overview

This trial is active, not recruiting.

Conditions intraocular melanoma, melanoma (skin)
Treatment romidepsin
Phase phase 2
Target HDAC
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

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Masking open label
Primary purpose treatment

Primary Outcomes

Measure
Response rate
time frame:
Progression-free and overall survival
time frame:
Toxicity
time frame:

Eligibility Criteria

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

Additional Information

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.
Trial information was received from ClinicalTrials.gov and was last updated in March 2012.
Information provided to ClinicalTrials.gov by Eastern Cooperative Oncology Group.