Le23 CPG: A Phase I/II Study of Intratumoral Injection of CPG 7909, A TLR 9 Agonist, Combined With Local Radiation in Recurrent Low-Grade Lymphomas
Patients must meet all of the following criteria in order to be
eligible for entry into the trial.
- Biopsy confirmed low-grade B-cell lymphoma of any initial stage or mycosis fungoides
of stage IB-IVA. B-cell lymphoma patients must have failed at least one prior
treatment. Mycosis fungoides patients must have failed or have been intolerant of at
least 2 topical or one systemic treatment.
- Patients must have at least one site of disease that is accessible for intratumoral
injection of CpG percutaneously
- Tumor specimens must be available for immunological studies either from a previous
biopsy or a new biopsy obtained before the initiation of the treatment.
- Patients must have measurable disease other than the injection site or biopsy site.
- 18 years of age or older
- Karnofsky Performance Status (KPS) of > 70.
- Adequate bone marrow function: WBC>4,000uL, hemoglobin > 10g/dL; platelet count
>100,000/mm3; ANC> 1000.
- Adequate hepatic function: bilirubin <= 1.5 mg/dL; SGOT/SGPT<3xupper limit of normal
- Adequate renal function: serum creatinine <= 2.0mg/dL.
- Required wash out periods for prior therapy:
- Topical therapy: 2 weeks
- Chemotherapy: 4 weeks
- Radiotherapy (including photo therapy): 4 weeks
- Systemic biological therapy for mycosis fungoides: 4 weeks
- Other investigational therapy: 4weeks
- Rituximab: 12 weeks
- Patients of reproductive potential and their partners must agree to use an effective
(>90% reliability) form of contraception during the study and for 4 weeks following
the last study drug administration.
- Women of reproductive potential must have negative urine pregnancy test.
- Life expectancy greater than 4 months.
- Able to comply with the treatment schedule.
Exclusion Criteria:A patient may not be enrolled in the trial if any of the following
criteria are met.
- Pre-existing autoimmune or antibody mediated disease including: systemic lupus,
erythematosus, rheumatoid arthritis, multiple sclerosis, Sjogren's syndrome,
autoimmune thrombocytopenia, but excluding controlled thyroid disease, or the
presence of autoantibodies without clinical autoimmune disease.
- Known history of human immunodeficiency virus (HIV), hepatitis B or hepatitis C
(active, prior treatment, or both).
- Patients with active infection or with a fever >38.50 C within three days prior to
the first scheduled treatment.
- CNS metastases
- Prior malignancy (active within 5 years of screening) except basal cell or completely
excised non-invasive squamous cell carcinoma of the skin, or in situ squamous cell
carcinoma of the cervix.
- History of allergic reactions attributed to compounds of similar composition to CpG
- Current anticoagulant therapy (ASA<= 325mg/day allowed).
- Significant cardiovascular disease (i.e. NYHA class 3 congestive heart failure;
myocardial infarction with the past 6 months; unstable angina; coronary angioplasty
with the past 6 months; uncontrolled atrial or ventricular cardiac arrhythmias).
- Pregnant or lactating.
- Any other medical history, including laboratory results, deemed by the investigator
to be likely to interfere with their participation in the study, or to interfere with
the interpretation of the results.