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 and non-pregnant femails aged ≥ 18 years 2. Histologically confirmed diagnbosis 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 treament with at least three forms of systemic therpay one of which must have been bexarotene, unless treatment with oral bexarotene was not tolerated or was medically contraindicated 4. Anitipated life expectancy > 6 months 5. Performance status of 0,1 or 2 by ECOG 6. Females of child bearing potential must have a negative serum prenancy test within 14 days prior to intiation 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 mimimize the risk of pregnancy for the duration of the study 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 1. Proven or suspected extracutaneous visceral CTCL involvement (M1) (CTCL stage IVb)prescence of lymphadenopathy is permitted 2. Previous treatment with forodesine 3. ECOG performance status >2 4. Concomitant use of any anti-cancer therpay or immune modifer 5 Concomitant use of any investigational agent or device 6. Concomitant treatment with any other anti-CTCL therapy or radiation therapy. Topical corticosteriods (except clases 1 and 2 which are prohibited) or low dose oral corticosteriods (≤10 mg/day prednisone or equivalent) will not be excluded, but if used must be a stable dose and schedle during the four weeks immediately prior to the study entry 7. Use of previous therapies for CTCL withi the previous 30 days: a)Phototherapy b. electron beam therapy, photophoresis, systemic anticancer therpay, interferon therapy, or other investigational therapy c. oral retinoid (including bexarotene) d. Alemtuzumab (Campath) or other monoclonal antibody e. Vorinostat or other HDAC inhibitor f. any investigational therapy Hepatic/Renal/ Metabolic EXcl Criteria 8. ALT or AST > 3 times ULN or alkaline phosphatase >2 times ULN 9. Calculated creatinine clearance ≤50ml/min or serum creatine ≥1.8 mg/dl 10 Serum potassium <3.3mg/dl or >5.5 mg/dl 11. Evidence of clinically significant (uncontrolled) hypo or hyperthyroidism CArdiovascular criteria 12. REcent(in the past 6 months) medically significant cardiac event 13. Prescence of congestive heart failure (NYHA IV) or angina (NYHA class IV) or prescence of a medically significant dysrhythmia 14. Prescence of the following ECG findings a. Congenital long QT syndrome; b. QTc interval >480 msec (Bazett?s correction); 14. Presence of uncontrolled hypertension manifested by systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥90 mmHg; Hematologic Exclusion Criteria 15. Hemoglobin <9.0 gm/dL (intermittent red blood cell transfusions permitted); 16. Absolute neutrophil count <1500 cells/mm3; 17. Platelet count <75,000/mm3; 18. Requirement for neutrophil or platelet growth factor therapy or administration of such therapy in the previous 30 days; 19. CD4 count <200/mm3; Infection-Related Exclusion Criteria 20. Documented current active infection with HIV, Hepatitis B, Hepatitis C, and/or CMV; 21. Presence of uncontrolled bacterial or viral infection (subject may be receiving chronic antimicrobial therapy); or, 22. History of culture-documented bacteremia in the previous 2 weeks. General Exclusion Criteria 23. 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); 24. Presence of any acute or chronic non-oncologic disease which, in the opinion of the investigator, is medically uncontrolled; 25. Coexistent second malignancy or history of prior malignancy within previous 5 years [excluding basal cell or squamous cell carcinoma of skin and cervical neoplasia (carcinoma-insitu) that has been treated curatively]. Surgically resected nonmelanomatous skin cancer (non-CTCL) with no evidence of recurrence in previous 6 months is permitted; and, 26. Any significant medical or psychiatric condition that, in the opinion of the investigator, might prevent the subject from complying with all

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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