Basic Trial Information
Trial Description
     Summary
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Active	18 and over	Pharmaceutical / Industry	GPI-04-0001 NCT00106431

Trial Description

Summary

GPI-04-0001 is a Phase II, non-randomized, open label, single arm study that will be conducted at approximately 20 sites, primarily in Europe. It will assess the efficacy, safety, and tolerability of depsipeptide as a treatment for cutaneous T-cell lymphoma (CTCL). Study patients will receive depsipeptide in a dose of 14 mg/m^2 intravenously over 4 hours on Days 1, 8 and 15 of each 28-day cycle. The duration of study treatment is 6 cycles although patients who show an objective response or stable disease may continue to receive therapy, at the discretion of the investigator, until disease progression or another withdrawal criterion is met.

Eligibility Criteria

Inclusion Criteria: Patients must fulfill all of the following criteria to be eligible for study participation:

• Males or non-pregnant females aged 18 or over.

• Histologically confirmed diagnosis of CTCL, including mycosis fungoides and Sézary syndrome.

• Patients with CTCL stages II-A, II-B, III, and IV-A only.

• Patients with CTCL stage Ib who have relapsed following previous therapy and where, in the investigator’s opinion, the potential benefit of treatment with FK228 outweighs the possible risks.

• Patients who have failed standardized skin-directed therapy and have had at least one course of systemic therapy, such as interferon, Ontak®, chemotherapy or Targretin®, etc., which they have deemed to have failed.

• Anticipated life expectancy greater than six months.

• Written informed consent to participate in the study.

Exclusion Criteria: Patients are ineligible for entry if any of the following criteria are met:

• ECOG Performance Status >1.

• Patients who have not received at least 1 course of prior systemic therapy for CTCL.

• Visceral involvement i.e. Stage 4b disease (lymphadenopathy is allowed).

• Patients with known cardiac abnormalities such as:

* Congenital long QT syndrome

* QTc interval >480 milliseconds

* Any cardiac arrhythmia requiring anti-arrhythmic medication.

• Patients who have had a myocardial infarction within 12 months of study entry.

• Patients who have a history of coronary artery disease (CAD) e.g. angina Canadian class II to IV. In any patient in whom there is doubt, the patient should have a stress imaging study and exercise ECG and, if abnormal, angiography to define whether or not CAD is present.

• Patients with an ECG recorded at screening showing evidence of cardiac ischaemia (ST depression of >=2 mm). If in any doubt, the patient should have a stress imaging study and exercise ECG and, if abnormal, angiography to define whether or not CAD is present.

• Patients with congestive heart failure that meets New York Heart Association class II to IV definitions and/or ejection fraction <40% by multiple gated acquisition (MUGA) scan or <50% by echocardiogram and/or magnetic resonance imaging (MRI)

• Patients with a history of sustained ventricular tachycardia (VT), ventricular fibrillation (VF), Torsade de Pointes, or cardiac arrest, unless currently addressed with an automatic implantable cardioverter defibrillator (AICD).

• Patients with hypertrophic cardiomegaly or restrictive cardiomyopathy from prior treatment or other causes (if in doubt, see ejection fraction criteria above).

• Patients with uncontrolled hypertension, i.e. >=160/95 mmHg.

• Concomitant use of any anti-cancer therapy.

• Concomitant use of warfarin (due to a drug interaction).

• Concomitant use of any investigational agent.

• Use of any investigational agent within 4 weeks of study entry.

• Concomitant use of drugs which may cause a prolongation of the QTc interval.

• Patients with a potassium level of <3.5 mmol/L and a magnesium level of <0.8 mmol/L.

• Clinically significant active infection.

• Known infection with human immunodeficiency virus (HIV), hepatitis B, or hepatitis C.

• Inadequate bone marrow or other organ function, as evidenced by:

* unsupported haemoglobin <9.0 g/dL (transfusions and/or erythropoietin are permitted);

* absolute neutrophil count (ANC) <=1.5 x 10[9]/L;

* platelet count <100 x 10[9]/L;

* total bilirubin >1.25 x upper limit of normal (ULN) for institution,

* aspartate transaminase/glutamic oxaloacetic transaminase (AST/SGOT) and alanine transaminase/ glutamic pyruvic transaminase (ALT/SGPT) >2.0 x ULN, serum creatinine >2.0 x ULN for age and sex;

• Coexistent second malignancy or history of prior malignancy within previous 5 years (excluding basal or squamous cell carcinoma of the skin or cervical epithelial neoplasm [CIN1, carcinoma in situ] that has been treated curatively).

• Any significant medical or psychiatric condition that might prevent the patient from complying with all study procedures.

• Use of topical steroids in the previous 2 weeks or systemic steroids in the previous 4 weeks.

• Having previously given consent to participate in this study.

• Concomitant use of CYP3A4 inhibitors.

Trial Contact Information

Trial Lead Organizations/Sponsors

Gloucester Pharmaceuticals

For more information on this trial, please call :

Ph: 888-GPI-CTCL(474-2825)

U.S.A.
California
	Los Angeles
	Jonsson Comprehensive Cancer Center at UCLA
		Alex Shalaurov, MD, Ph.D.	Ph: 919-462-2274
			Email: alex.shalaurov@nc.crl.com
	Stanford
	Stanford Cancer Center
		Alex Shalaurov, MD, Ph.D	Ph: 919-462-2274
			Email: alex.shalaurov@nc.crl.com
	Various Cities
	Charles River Laboratories Clinical Service
		Alex Shalaurov, MD, Ph.D.	Ph: 919-462-2274
			Email: alex.shalaurov@nc.crl.com
Massachusetts
	Boston
	Boston University Cancer Research Center
		Alex Shalaurov, MD, Ph.D.	Ph: 919-462-2274
			Email: alex.shalaurov@nc.crl.com
	Various Cities
	Charles River Laboratories Clinical Service
		Alex Shalaurov, MD, Ph.D.	Ph: 919-462-2274
			Email: alex.shalaurov@nc.crl.com
Pennsylvania
	Philadelphia
	Abramson Cancer Center of the University of Pennsylvania
		Alex Shalaurov, MD, Ph.D.	Ph: 919-462-2274
			Email: alex.shalaurov@nc.crl.com
Texas
	Houston
	M. D. Anderson Cancer Center at University of Texas
		Alex Shalaurov, MD, Ph.D.	Ph: 919-462-2274
			Email: alex.shalaurov@nc.crl.com
	Temple
	Scott and White Cancer Institute
		Alex Shalaurov, MD, Ph.D	Ph: 919-462-2274
			Email: alex.shalaurov@nc.crl.com
	Various Cities
	Charles River Laboratories Clinical Service
		Alex Shalaurov, MD, Ph.D.	Ph: 919-462-2274
			Email: alex.shalaurov@nc.crl.com
Germany
	Various Cities
	Research Site
		Dr. Cecil Treadwell	Ph: 44-141-222-5543
Poland
	Various Cities
	Research Site
		Dr. Cecil Treadwell	Ph: 44-141-222-5543
United Kingdom
	Various Cities
	Research Site
		Dr. Cecil Treadwell	Ph: 44-141-222-5543

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00106431
Information obtained from ClinicalTrials.gov on 2006-06-09