Clinical trial · Interventional
FR901228 in Treating Patients With Unresectable Stage III or Stage IV Malignant Melanoma
Phase II Trial of Depsipeptide (NSC 630176) in Advanced Malignant Melanoma
NCT00104884CI-TRIAL-00067607terminatedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): The study was terminated on May 17, 2006 due to slow accrual.
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Depsipeptide | Drug | Romidepsin | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Depsipeptide
- description
- Depsipeptide is administered as a 4-hour IV infusion weekly in doses of 13 mg/m\^2 for 3 weeks. Repeat cycle every 28 days until unacceptable toxicity or disease progression.
- interventionNames
- Drug: Depsipeptide
Primary outcomes (1)
- measure
- Proportion of Patients With Response to Depsipeptide
- timeFrame
- Assessed every 3 months if patient is < 2 years from study entry; every 6 months if patient is 2 - 3 years from study entry, up to 3 years
- description
- Response is evaluated using Solid Tumor Response Criteria (RECIST) and defined as either complete repose (CR) or partial response (PR). Per RECIST criteria, CR = disappearance of all target and nontarget lesions; PR = at least 30% decrease in the sum of the longest diameters of target lesions from baseline, and persistence of one or more non-target lesion(s) and/or the maintenance of tumor marker level above the normal limits.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Stage III unresectable or American Joint Committee on Cancer (AJCC) stage IV cutaneous, mucosal, ocular, or unknown primary melanoma with measurable disease by physical examination or imaging studies. * Palpable cutaneous or nodal metastases suitable for punch, trucut, or similar biopsy if the patient agrees. * Normal electrocardiogram (EKG) * Left ventricular ejection fraction (LVEF) \> 40% by Multi Gated Acquisition Scan (MUGA) * Corrected QT (QTc) \< 500 msec * Age greater than or equal to 18 * Negative pregnancy test * Fertile patients must use effective contraception * Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2 * Normal organ and marrow function * Patients on hydrochorthiazide should be switched to a potassium-sparing diuretic or another antihypertensive * At least 4 weeks since prior radiotherapy * Patients with cardiac hypertrophy may be enrolled but should be carefully monitored. Exclusion Criteria: * Prior FR901228 (depsipeptide) * Prior chemotherapy * Other concurrent chemotherapy * Active central nervous system (CNS) metastases by brain computed tomography (CT) scan or magnetic resonance imaging (MRI) * History of coronary atherosclerotic heart disease * History of myocardial infarction * History of congestive heart failure * Non-melanoma malignancy within the past 5 years except carcinoma in situ or squamous cell or basal cell skin cancer * Pregnant or nursing women * Conditions that in the opinion of the investigator would interfere with the ability of the patient to complete this protocol * History of allergic reactions attributed to compounds of similar chemical or biologic composition to Depsipeptide * Co-medication with an agent that causes QTc prolongation * Human immunodeficiency virus (HIV) positive patients receiving combination anti-retroviral therapy * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, or psychiatric illness/social situations that would limit compliance with study requirements * Concurrent radiotherapy * Left ventricular hypertrophy (LVH) on their baseline EKG tracing
References
Publications (0)
Data not yet available
No reference posted for this study.