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CPG 7909 + Local Radiotherapy in Recurrent Low-Grade Lymphomas

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00185965
Recruitment Status : Completed
First Posted : September 16, 2005
Results First Posted : August 1, 2014
Last Update Posted : August 1, 2014
Sponsor:
Collaborators:
Lymphoma Research Foundation
American Society of Clinical Oncology
Information provided by (Responsible Party):
Ronald Levy, Stanford University

Study Description
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Brief Summary:
Brief summary TBD

Condition or disease Intervention/treatment Phase
Non-Hodgkin Lymphoma Mycosis Fungoides Drug: CPG 7909 Phase 1 Phase 2

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : July 2004
Actual Primary Completion Date : March 2010
Actual Study Completion Date : March 2010

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Lymphoma, B-cell low-grade (BCL)
Recurrent low-grade B-cell lymphoma patients (at least one prior treatment failure)
 Drug: CPG 7909
6 mg intratumoral injection, administered immediately before 2 Gy radiotherapy (RT) to a designated tumor lesion, about 24 hours later after a 2nd 2 Gy RT dose, then weekly for 8 additional weeks (total of 10 injections).
Other Names:
  • PF-3512676
  • CPG-enriched TLR9 agonist
  • CPG
Experimental: Mycosis fungoides (MF)

Mycosis fungoides patients must have failed or have been intolerant of at least 1 topical or 1 systemic treatment

Recurrent mycosis fungoides patients (at least one prior failure of topical or systemic treatment)

 Drug: CPG 7909
6 mg intratumoral injection, administered immediately before 2 Gy radiotherapy (RT) to a designated tumor lesion, about 24 hours later after a 2nd 2 Gy RT dose, then weekly for 8 additional weeks (total of 10 injections).
Other Names:
  • PF-3512676
  • CPG-enriched TLR9 agonist
  • CPG


Outcome Measures
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Primary Outcome Measures :
  1. Objective Response Rate (ORR) [ Time Frame: 12 weeks ]
    Objective Response Rate (ORR) consisting of Complete Response (CR) + Partial Response (PR), not including Stable Disease (SD)


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00185965


Locations
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United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Ronald Levy
Lymphoma Research Foundation
American Society of Clinical Oncology
Investigators
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Principal Investigator: Ronald Levy Stanford University
More Information
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Publications of Results:

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Responsible Party: Ronald Levy, Robert K. and Helen K. Summy Professor in the School of Medicine, Stanford University
ClinicalTrials.gov Identifier: NCT00185965    
Other Study ID Numbers: IRB-13063
80057 ( Other Identifier: Stanford University Alternate IRB Number )
LYMNHL0014 ( Other Identifier: OnCore )
First Posted: September 16, 2005    Key Record Dates
Results First Posted: August 1, 2014
Last Update Posted: August 1, 2014
Last Verified: July 2014
Keywords provided by Ronald Levy, Stanford University:
non-Hodgkin
lymphoma
mycosis
fungoides
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, Non-Hodgkin
Lymphoma, T-Cell, Cutaneous
Lymphoma, T-Cell
Mycoses
Mycosis Fungoides
Neoplasms by Histologic Type
 Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Bacterial Infections and Mycoses
Infections