| September 12, 2005 |
| October 30, 2009 |
| July 2004 |
| January 2009 (final data collection date for primary outcome measure) |
| Feasibility and safety of intratumoral injection of CpG combined with local radiation in patients with recurrent low-grade lymphomas. [ Time Frame: Baseline, week 1 Day 1, week 1 day 2, week 2 day 8, week 3 day 15, week 4 day 22 (day 23 for MF patients only), week 5 day 29, week 6 day 36, week 7 day 43, week 8 day 50, week 9 day 57, week 12 day 78, every 2-6 months as per standard of care. ] [ Designated as safety issue: Yes ] |
| To determine the feasibility and safety of intratumoral injection of CpG combined with local radiation in patients with recurrent low-grade lymphomas. |
| Complete list of historical versions of study NCT00185965 on ClinicalTrials.gov Archive Site |
- Local and systemic anti-tumor efficacy. [ Time Frame: baseline, week 6, week 12 - all patients; weeks 2, 3, 4 - MF patients only ] [ Designated as safety issue: No ]
- Tumor-specific humoral and cellular immune responses. [ Time Frame: baseline, week 6, week 12 - all patients; weeks 2, 3, 4 - MF patients only ] [ Designated as safety issue: No ]
|
- 1. To determine local and systemic anti-tumor efficacy.
- 2. To evaluate tumor-specific humoral and cellular immune responses.
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| |
| Phase I/II CPG 7909 + Local XRT in Recurrent Low-Grade Lymphomas |
| 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 |
This is a single institution phase I / II trial to evaluate the safety, feasibility and efficacy of CpG injections (4 intratumoral injections followed by 6 peri-tumoral injections) combined with local irradiation in patients with recurrent low-grade lymphomas.
Patients will receive low-dose radiotherapy to a single tumor site on days 1 and 2 (2 Gy each day). CpG injections will be administered into the same tumor site within the 24 hours before and the 24 hours after the radiation, and on days 8 and 15. Weekly doses of CpG will be then administered subcutaneously in the region of previous injections for 6 additional doses. |
| |
| Phase I, Phase II |
| Interventional |
| Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
| Lymphoma, Non-Hodgkin |
- Drug: CPG 7909
- Procedure: Local radiation
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| |
| |
| |
| Active, not recruiting |
| 30 |
| December 2010 |
| January 2009 (final data collection date for primary outcome measure) |
Inclusion Criteria:Patients must meet all of the following criteria in order to be eligible for entry into the trial.
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 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.
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| Both |
| 18 Years and older |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| United States |
| |
| NCT00185965 |
| Ronald Levy, Stanford University School of Medicine |
| LYMNHL0014, 80057, LYMNHL0014, NCT00185965, NIH |
| Stanford University |
- Lymphoma Research Foundation
- American Society of Clinical Oncology
- National Institutes of Health (NIH)
|
| Principal Investigator: |
Ronald Levy |
Stanford University |
|
|
| Stanford University |
| October 2009 |