| Exclusion Criteria: | 1) Proven or suspected extracutaneous visceral CTCL involvement (M1) (CTCL stage IVB) (presence of lymphadenopathy is permitted) [CTCL-related Exclusion Criteria].
2) Previous treatment with Forodesine [CTCL-related Exclusion Criteria].
3) ECOG performance status >2 [CTCL-related Exclusion Criteria].
4) Concomitant use of any anti-cancer therapy or immune modifier [CTCL-related Exclusion Criteria].
5) Concomitant use of any investigational agent or device [CTCL-related Exclusion Criteria].
6) Concurrent treatment with any other anti-CTCL therapy, or radiation therapy [topical corticosteroids (classes 1 and 2 prohibited) or low dose oral corticosteroids (10 mg/day prednisone or equivalent) will not be excluded, but if used, the dose and schedule must be stable during the four weeks immediately prior to study entry] [CTCL-related Exclusion Criteria].
7) Use of previous therapies for CTCL within the timeframes specified: 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; Alemtuzumab (Campath) or other monoclonal antibody within the previous 30 days; d.) Vorinostat or other HDAC inhibitor within previous 30 days; e.) Any investigational therapy within the previous 30 days [CTCL-related Exclusion Criteria].
8) ALT or AST > 3 times ULN or alkaline phosphatase > 2 times ULN [Hepatic/Renal/Metabolic Exclusion Criteria].
9) Calculated creatinine clearance </= 50 mL/min or serum creatinine >/= 1.8 mg/dL [Hepatic/Renal/Metabolic Exclusion Criteria].
10) Serum potassium < 3.3 mg/dL or > 5.5 mg/dL [Hepatic/Renal/Metabolic Exclusion Criteria].
11) Evidence of clinically significant (uncontrolled) hypo or hyperthyroidism [Hepatic/Renal/Metabolic Exclusion Criteria].
12) Recent (in past 6 months) medically significant cardiac event (i.e., myocardial infarction, cardiac surgery) [Cardiovascular Exclusion Criteria].
13) Presence of congestive heart failure (NYHA class IV) or angina (NYHA class IV) or presence of a medically significant dysrhythmia [Cardiovascular Exclusion Criteria].
14) Presence of any of the following ECG findings: a.) Congenital long QT syndrome; b.) QTc interval >480 msec (Bazett's correction) [Cardiovascular Exclusion Criteria].
15) Presence of uncontrolled hypertension manifested by systolic blood pressure >/= 160 mmHg and/or diastolic blood pressure >/= 90 mmHg [Cardiovascular Exclusion Criteria].
16) Hemoglobin < 9.0 gm/dL (intermittent red blood cell transfusions permitted) [Hematologic Exclusion Criteria].
17) Absolute neutrophil count < 1500 cells/mm^3 [Hematologic Exclusion Criteria].
18) Requirement for neutrophil or platelet growth factor therapy or administration of such therapy in the previous 30 days [Hematologic Exclusion Criteria].
19) CD4 count < 200/mm^3 [Hematologic Exclusion Criteria].
20) Documented current active infection with HIV, Hepatitis B, Hepatitis C, and/or CMV [Infection-Related Exclusion Criteria].
21) Presence of uncontrolled bacterial or viral infection (subject may be receiving chronic antimicrobial therapy) [Infection-Related Exclusion Criteria].
22) History of culture-documented bacteremia in the previous 2 weeks [Infection-Related 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) [General Exclusion Criteria].
24) Presence of any acute or chronic non-oncologic disease which, in the opinion of the investigator, is medically uncontrolled [General Exclusion Criteria].
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-in-situ) that has been treated curatively]. Surgically resected nonmelanomatous skin cancer (non-CTCL) with no evidence of recurrence in previous 6 months is permitted [General Exclusion Criteria].
26) Any significant medical or psychiatric condition that, in the opinion of the investigator, might prevent the subject from complying with all required study procedures [General Exclusion Criteria]. |