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CPG 7909 + Local Radiotherapy 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: July 7, 2014
Last verified: July 2014
  Purpose

Brief summary TBD


Condition Intervention Phase
Non-Hodgkin Lymphoma
Mycosis Fungoides
Drug: CPG 7909
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Objective Response Rate (ORR) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Objective Response Rate (ORR) consisting of Complete Response (CR) + Partial Response (PR), not including Stable Disease (SD)


Enrollment: 30
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: 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

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: IRB-13063, 80057, LYMNHL0014
Study First Received: September 12, 2005
Results First Received: July 7, 2014
Last Updated: July 7, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Stanford University:
non-Hodgkin
lymphoma
mycosis
fungoides

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Non-Hodgkin
Mycoses
Mycosis Fungoides
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoma, T-Cell
Lymphoma, T-Cell, Cutaneous
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on November 27, 2014