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Phase I/II CPG 7909 + Local XRT in Recurrent Low-Grade Lymphomas
This study is currently recruiting participants.
Verified by Stanford University, September 2008
Sponsors and Collaborators: Stanford University
Lymphoma Research Foundation
American Society of Clinical Oncology
National Institutes of Health (NIH)
Information provided by: Stanford University
ClinicalTrials.gov Identifier: NCT00185965
  Purpose

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.


Condition Intervention Phase
Lymphoma, Non-Hodgkin
Drug: CPG 7909
Procedure: Local radiation
Phase I
Phase II

MedlinePlus related topics: Cancer Lymphoma
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title: 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

Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Feasibility and safety of intratumoral injection of CpG combined with local radiation in patients with recurrent low-grade lymphomas.

Secondary Outcome Measures:
  • Local and systemic anti-tumor efficacy.
  • Tumor-specific humoral and cellular immune responses.

Estimated Enrollment: 30
Study Start Date: July 2004
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria: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.&#xA; 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00185965

Locations
United States, California
Stanford University School of Medicine Recruiting
Stanford, California, United States, 94305
Contact: Daniel Navi, MD     650-736-2300     dnavi@stanford.edu    
Contact: Cancer Clinical Trials Office     (650) 498-7061        
Principal Investigator: Ronald Levy            
Sub-Investigator: Weiyun Ai            
Sub-Investigator: Joshua Brody            
Sub-Investigator: Richard T. Hoppe            
Sub-Investigator: Sandra Jeane Horning            
Sub-Investigator: Youn H Kim            
Sub-Investigator: Susan J Knox            
Sub-Investigator: Sabine Kohler            
Sub-Investigator: Irene L. Wapnir            
Sponsors and Collaborators
Stanford University
Lymphoma Research Foundation
American Society of Clinical Oncology
Investigators
Principal Investigator: Ronald Levy Stanford University
  More Information

Study ID Numbers: LYMNHL0014, 80057, LYMNHL0014, NCT00185965, NIH
Study First Received: September 12, 2005
Last Updated: October 3, 2008
ClinicalTrials.gov Identifier: NCT00185965  
Health Authority: United States: Institutional Review Board

Study placed in the following topic categories:
Lymphatic Diseases
Immunoproliferative Disorders
Lymphoproliferative Disorders
Lymphoma, Non-Hodgkin
Lymphoma
Recurrence

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Histologic Type
Immune System Diseases

ClinicalTrials.gov processed this record on January 14, 2009