Single agent phase II study of Forodesine (BCX1777) in the treatment of cutaneous T-Cell Lymphoma - forodesine in CTC

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 150

Inclusion Criteria

1. Males or non-pregnant females aged =18 years;
2. Histologically confirmed diagnosis of CTCL, including mycosis fungoides and/or sezary syndrome;
3. Subjects with CTCL stages IB, IIA, IIB, III or IVA who have persistent, progressive, or recurrent disease during or following treatment with at least three forms of systemic therapy, one of which must have been bexarotene, unless treatment with oral bexarotene was not tolerated or was medically contraindicated;
4. Anticipated life expectancy > 6 months;
5. Performance status of 0, 1, or 2 by ECOG;
6. Females of childbearing potential must have a negative serum pregnancy test within 14 days prior to initiation of study treatment ;
7. Females of child bearing potential and sexually active males, if indicated, must be willing and able to use method(s) of contraception that are adequate to prevent or minimize the risk of pregnancy for the duration of the study; and,
8. Written informed consent to participate in the study.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

CTCL-related Exclusion Criteria

1. Proven or suspected extracutaneous visceral CTCL involvement (M1) (CTCL stage IVB) (note: presence of lymphadenopathy is permitted);
2. Previous treatment with forodesine;
3. ECOG performance status >2;
4. Concomitant use of any anti-cancer therapy or immune modifier;
5. Concomitant use of any investigational agent or device;
6. Concurrent treatment with any other anti-CTCL therapy, or radiation therapy. Topical corticosteroids (except classes 1 and 2 which are prohibited) or low dose oral corticosteroids (=10 mg/day prednisone or equivalent) will not be excluded, but if used, must be a stable dose and schedule during the four weeks immediately prior to study entry;
7. Use of previous therapies for CTCL within the timeframes specified below:
a. Phototherapy in the previous 30 days;
b. Electron beam therapy, photopheresis, systemic anticancer therapy, interferon therapy, or other investigational therapy in the previous 30 days;
c. Oral retinoid (including bexarotene) in the previous 30 days;
d. Alemtuzumab (Campath) or other monoclonal antibody within the previous 30 days
e. Vorinostat or other HDAC inhibitor within previous 30 days
f. Any investigational therapy within the previous 30 days;

Hepatic/Renal/Metaboli Exclusion Criteria

8. ALT or AST >3 times ULN or alkaline phosphatase >2 times ULN;
9. Calculated creatine clearance =50mL/min or serum creatine =1.8mg/dL;
10. Serum potassium <3.3mg/dL or >5.5mg/dL;
11. Evidence of clinically significant (uncontrolled) hypo- or hyperthyroidism;

Cardiovascular Exclusion Criteria

12. Recent (in past 6 months) medically significant cardiac event (i.e., myocardial infarction, cardiac surgery);
13. Presence of congestive heart failure (NYHA class IV) or angina (NYHA class IV) or presence of a medically significant dysrhythmia;
14. Presence of any of the following ECG findings:
a. Congenital long QT syndrome;
b. QTc interval >480 msec (Bazett’s correction);
15. Presence of uncontrolled hypertension manifested by systolic blood pressure =160mmHg and or diastolic blood pressure =90mmHg;

Hematologic Exclusion Criteria

16. Hemoglobin <9.0gm/dL (intermittent red blood cell transfusions permitted);
17. Absolute neutrophil count <1500cells/mm^3;
18. Platelet count <75,000/mm^3;
19. Requirement for neutrophil or platelet growth factor therapy or administration of such therapy in the previous 30 days;
20. CD4 count <200/mm^3

Infection-Related Exclusion Criteria

21. Documented current active infection with HIV, Hepatitis B, Hepatitis C and/or CMV;
22. Presence of uncontrolled bacterial or viral infection (subject may be receiving chronic antimicrobial therapy); or,
23. History of culture-documented bacteremia in the previous 2 weeks.

General Exclusion Criteria

24. Recent (i.e., in past 2 weeks) change in doses or regimens of medications used for any chronic non-oncologic condition for reasons of worsening of the chronic illness (change in doses of chronic medications associated with improvement in a chronic illness are not exclusionary);
25. Presence of any acute or chronic non-oncologic disease which, in the opinion of the investigator, is medically uncontrolled;
26. coexistent second malignancy or history of prior malignancy within 5 years [excluding basal cell or squamous cell carcinoma of skin and cervical neoplasia (carcinoma in situ) that has been treated curatively]. Surgically resected nonmelanomatous skin cancer (non-CTCL)

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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