Clareo Health | Phase I/II Study of Intratumoral Injection of CPG 7909, a TLR9 Agonist, Combined With Local Radiation for Patients With Recurrent Mycosis Fungoides.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Stanford University
With
National Institutes of Health (NIH)
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Patients must have at least one site of disease that is accessible for intratumoral injection of CpG percutaneously, and the second site to follow treatment response.
* Systemic biological therapy for mycosis fungoides: 4 weeks
* Other investigational therapy: 4weeks
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.
You may not be if
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.
Prior treatment with CpG.
History of allergic reactions attributed to compounds of similar composition to CPG 7909
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.
