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CPG 7909 + Local Radiotherapy in Recurrent Low-Grade Lymphomas | Clinical Trials | Clareo Health

COMPLETEDPHASE1/PHASE2

CPG 7909 + Local Radiotherapy in Recurrent Low-Grade Lymphomas

Le23 CPG: A Phase 1-2 Study of Intratumoral Injection of CPG 7909, A TLR 9 Agonist, Combined With Local Radiation in Recurrent Low-Grade Lymphomas

NCT00185965•Ronald Levy

View on ClinicalTrials.gov

Summary

Brief summary TBD

Detailed Description

This is a single institution phase 1-2 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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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:
+10 more criteria

Exclusion Criteria

•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.

Locations (1)

Stanford University School of Medicine

Stanford, California, United States

Key Dates

Start Date

July 1, 2004

Primary Completion Date

March 1, 2010

Completion Date

March 1, 2010

Last Updated

August 1, 2014

Enrollment

ACTUAL participants

Conditions

Non-Hodgkin LymphomaMycosis Fungoides

Interventions

CPG 7909

DRUG

A Study to Evaluate MK-1045 (CN201) in Participants With Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma (MK-1045-001/CN201-101)

NCT06189391

Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma

View study

RECRUITINGPHASE1/PHASE2

A Dose-Escalation and Expansion Study of BGB-16673 in Participants With B-Cell Malignancies

NCT05006716

B-cell MalignancyMarginal Zone Lymphoma+7 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 1, 2014Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

CPG 7909 + Local Radiotherapy in Recurrent Low-Grade Lymphomas

Inclusion Criteria

Exclusion Criteria

A Study to Evaluate MK-1045 (CN201) in Participants With Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma (MK-1045-001/CN201-101)

A Dose-Escalation and Expansion Study of BGB-16673 in Participants With B-Cell Malignancies

CD79b-19 CAR T Cells in Non-Hodgkin Lymphoma

A Study to Assess Safety and Efficacy of CHO-H01 as a Single Agent/Combined With Lenalidomide in Subjects With Refractory or Relapsed Non-Hodgkin's Lymphoma

A Study of (LY3527727) Pirtobrutinib in Participants With Previously Treated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma or Non-Hodgkin Lymphoma

Tegavivint for Treating Patients With Relapsed or Refractory Large B-Cell Lymphoma