Phase I/II CPG 7909 + Local XRT in Recurrent Low-Grade Lymphomas

This study has been completed.
Sponsor:
Collaborators:
Lymphoma Research Foundation
American Society of Clinical Oncology
Information provided by (Responsible Party):
Ronald Levy, Stanford University
ClinicalTrials.gov Identifier:
NCT00185965
First received: September 12, 2005
Last updated: December 29, 2012
Last verified: December 2012
  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
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


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. [ 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 26
Study Start Date: July 2004
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CpG 7909
Intratumoral injection 6 mg
Drug: CPG 7909
6 mg Intratumoral injection
Other Name: PF-3512676

  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.

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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Please refer to this study by its ClinicalTrials.gov identifier: NCT00185965

Locations
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
Principal Investigator: Ronald Levy Stanford University
  More Information

Publications:
Responsible Party: Ronald Levy, Robert K. and Helen K. Summy Professor in the School of Medicine, Stanford University
ClinicalTrials.gov Identifier: NCT00185965     History of Changes
Other Study ID Numbers: LYMNHL0014, 80057
Study First Received: September 12, 2005
Last Updated: December 29, 2012
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on July 31, 2014