| Inclusion Criteria: | 1) Advanced CTCL defined as stage IB or higher with histological diagnosis documented by biopsy within one year prior to study entry
2) Age >/= 18 years
3) Eastern Cooperative Oncology Group (ECOG) performance status 0-2
4) Evaluable disease
5) Received at least 2 systemic therapies: a.) photophoresis and any anti-cancer therapies that are administered parenterally or orally (continues in eligibility #6)
6) b.) Patients have received 2 systemic therapies if they have received a combination of one of these regimens: 1). An anti-cancer drug or biological agent (e.g., Ontak, interferon) in combination with photophoresis; 2). A cytotoxic drug in combination with a biological agent or retinoid (e.g., Targretin) or histone deacetylase inhibitor (e.g., Zolinza); 3). A combination of cytotoxic drugs with a biological agent or retinoid (e.g., Targretin) or histone deacetylase inhibitor (e.g., Zolinza); 4). A combination of retinoid with a biological agent (e.g., Targretin in combination with interferon)
7) Adequate bone marrow function: Absolute neutrophil count (ANC) >/= 1,500/microL, Platelet count >/= 100,000/microL
8) Adequate renal function:Creatinine </= 1.5 x ULN
9) Adequate liver function: total bilirubin </= 1.5 x ULN; alanine aminotransferase (ALT or SGPT) </= 2.5 x institutional ULN or </= 5 x ULN if the liver is involved by tumor
10) At least 3 weeks from prior systemic treatments, skin directed therapies (e.g., phototherapy, topical chemotherapy, or radiation), and have recovered from prior toxicities. Patients with rapidly progression disease, who are less than 3 weeks from prior treatment, may participate if they have recovered from prior treatment-related toxicities.
11) Not receiving topical steroids or have been receiving a stable dose of topical steroids for at least 2 weeks immediately prior to study entry
12) Able to swallow capsules
13) At least 3 weeks from major surgery
14) Agree to practice effective contraception after signing the informed consent form and during the entire study period until one month after being discontinued from the study unless documentation of infertility exists. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
15) Ability to understand and willingness to sign the informed consent form
16) Prior treatment with gemcitabine. |