CpG 7909 in Treating Patients With Cutaneous T-Cell Lymphoma

DISEASE CHARACTERISTICS:

• Histologically confirmed cutaneous T-cell lymphoma (CTCL) (limited to mycosis fungoides)

  • Stage IB-IVA disease
  • No other cutaneous lymphomas including, but not limited to, CD30-positive large-cell T-cell lymphoma, lymphomatoid papulosis, and pagetoid reticulosis
  • No visceral disease (stage IVB CTCL)
• Must have received 1-3 prior systemic regimen(s), including psoralen ultraviolet light therapy (PUVA)
• No CNS disease

PATIENT CHARACTERISTICS:

Age

• 18 and over

Performance status

• Karnofsky 60-100%

Life expectancy

• More than 4 months

Hematopoietic

• Neutrophil count ≥ 1,000/mm^3
• Platelet count > 100,000/mm^3
• WBC > 4,000/mm^3
• Hemoglobin ≥ 10 g/dL

Hepatic

• Bilirubin ≤ 1.5 mg/dL
• SGOT or SGPT < 3 times upper limit of normal
• PTT ≤ 40 seconds
• No active hepatitis B or C

Renal

• Creatinine ≤ 2.0 mg/dL

Cardiovascular

• No unstable angina
• No New York Heart Association class III-IV congestive heart failure
• No myocardial infarction within the past 6 months
• No uncontrolled atrial or ventricular cardiac arrhythmias
• No other significant cardiovascular disease

Immunologic

• HIV negative

• No autoimmune or antibody-mediated disease, including any of the following:

  • Systemic lupus erythematosus
  • Rheumatoid arthritis
  • Multiple sclerosis
  • Sjögren's syndrome
  • Autoimmune thrombocytopenia
• Controlled thyroid disease allowed
• Autoantibodies without clinical autoimmune disease allowed
• No history of allergic reactions attributed to compounds of similar composition to CpG 7909
• No fever ≥ 38.2°C within the past 24 hours
• No serious, symptomatic, significant local or systemic infection, including urinary tract infection

Other

• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception during and for 4 weeks after study participation
• No suspected or confirmed poor compliance, mental instability, or prior or current alcohol or drug abuse that would preclude study participation or giving informed consent
• No other medical history, including laboratory results, that would preclude study participation
• No other malignancy within the past 5 years except basal cell or completely excised non-invasive squamous cell skin cancer or squamous cell carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY:

Biologic therapy

• No concurrent denileukin diftitox
• No other concurrent immunotherapy, including but not limited to, interleukin-2, interferon (IFN) alfa, or IFN gamma

Chemotherapy

• At least 4 weeks since prior systemic chemotherapy for CTCL
• No concurrent chemotherapy

Endocrine therapy

• No concurrent topical or systemic corticosteroids

Radiotherapy

• At least 4 weeks since prior electron beam therapy for CTCL
• No concurrent radiotherapy

Surgery

• More than 6 months since prior coronary angioplasty

Other

• At least 2 weeks since prior topical therapy for CTCL
• At least 3 weeks since prior phototherapy for CTCL
• At least 4 weeks since prior photopheresis for CTCL
• At least 4 weeks since other prior systemic therapy for CTCL
• At least 4 weeks since prior daily systemic cholecalciferol (vitamin D) > 15,000 IU for CTCL
• At least 4 weeks since prior oral retinoids, including bexarotene for CTCL
• At least 4 weeks since prior investigational therapy for CTCL
• No prior treatment for hepatitis B or C

• More than 2 weeks since prior systemic antibiotics for CTCL

  • Patients receiving systemic antibiotics for CTCL must be on a stable regimen for at least 2 weeks before study entry
• More than 30 days since prior participation in an investigational drug trial
• No concurrent chloroquine phosphatase
• No concurrent anticoagulant therapy except aspirin (≤ 325 mg/day)
• No concurrent phototherapy
• No concurrent photopheresis therapy
• No concurrent bexarotene
• No concurrent immunosuppressants
• No other concurrent investigational drugs