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

NCT00104884 | Terminated Phase 2 Results

• 3 other identifiers: CDR0000415355U10CA021115E1603
• Study Type: interventional
• Target: 4
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Malignant Melanoma; Melanoma

Keywords

stage III melanoma; stage IV melanoma; Depsipeptide

Outcome Measures

Primary Outcomes (1)

• Proportion of Patients With Response to Depsipeptide

  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.

  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

Study Arms (1)

Depsipeptide

EXPERIMENTAL

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.

Drug: Depsipeptide

Interventions

Depsipeptide DRUG

Given IV

Also known as: FR901228, FK228

Depsipeptide

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• ECOG-ACRIN Cancer Research Group: lead
• National Cancer Institute (NCI): collaborator

MeSH Terms

Conditions

Melanoma

Interventions

Depsipeptides; romidepsin

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Study Statistician
• Organization: ECOG-ACRIN Statistical Office

617-632-3012

Study Officials

• David H. Lawson, MD

  Emory University

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2005
• First Posted: March 4, 2005
• Study Start: October 4, 2005
• Primary Completion: May 1, 2006
• Study Completion: March 1, 2009
• Last Updated: June 28, 2023
• Results First Posted: March 2, 2016

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share