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A Phase 2 Intratumoral Injection PF-3512676 Plus Local Radiation in Low-Grade B-Cell Lymphomas

This study has been completed.
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Ronald Levy, Stanford University
ClinicalTrials.gov Identifier:
NCT00880581
First received: April 10, 2009
Last updated: January 24, 2017
Last verified: January 2017
  Purpose
To assess the feasibility of using intra-tumoral PF-3512676 in combination with local radiation as a therapy for lowgrade b-cell lymphoma.

Condition Intervention Phase
Lymphoma, Non-Hodgkin Lymphoma Lymphomas: Non-Hodgkin Follicular / Indolent B-Cell Lymphomas: Non-Hodgkin Drug: PF-3512676 Radiation: Local radiotherapy Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: A Phase 2 Study of Intratumoral Injection PF-3512676 in Combination With Local Radiation in Low-Grade B-Cell Lymphomas

Resource links provided by NLM:


Further study details as provided by Ronald Levy, Stanford University:

Primary Outcome Measures:
  • Overall ObjectiveResponse (ORR) Rate [ Time Frame: 12 weeks ]

    Overall objective response rate (OOR) at time of best response was assessed as the sum of the Complete Response (CR) rate and the Partial Response (CR, PR) rate. Response was assessed per the Cheson Criteria, as below.

    • Complete Response (CR) = Complete disappearance of all lesions, evidence, and effects of disease
    • CR/unconfirmed (CRu) = residual lymph node mass >1.5 cm but regressed >75%, with 1 residual lymph node mass >1.5 cm that has regressed by >75% and/or increased number or size of bone marrow aggregates without cytologic or architectural atypia
    • Partial Response (PR) = ≥50% decrease in SPD of the 6 largest lesions with no increase in the size of the other nodes; splenic / hepatic nodules regress ≥50%, and with no new sites of disease Stable disease (SD) = less than PR.


Secondary Outcome Measures:
  • Response Rate After Cycle 2 [ Time Frame: 6 months ]

    Response after a second cycle of treatment was assessed per the Cheson Criteria, as below.

    • Complete Response (CR) = Complete disappearance of all lesions, evidence, and effects of disease
    • CR/unconfirmed (CRu) = residual lymph node mass >1.5 cm but regressed >75%, with 1 residual lymph node mass >1.5 cm that has regressed by >75% and/or increased number or size of bone marrow aggregates without cytologic or architectural atypia
    • Partial Response (PR) = ≥50% decrease in SPD of the 6 largest lesions with no increase in the size of the other nodes; splenic / hepatic nodules regress ≥50%, and with no new sites of disease Stable disease (SD) = less than PR.


Enrollment: 30
Study Start Date: January 2009
Study Completion Date: January 2015
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PF-3512676
Patients will be treated with 18 mg PF-3512676 by intratumoral injection on day 2 following local radiotherapy, then weekly for a total of 10 injections over 10 weeks.
Drug: PF-3512676
18 mg injection
Other Names:
  • CpG 7909
  • CpG
  • ProMune
Radiation: Local radiotherapy
2 gray (2 Gy) on each of Days 1 and 2

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Biopsy confirmed low-grade B-cell lymphoma diagnosed as follicular grade 1 or 2, marginal zone or small lymphocytic lymphoma of any initial stage.
  • Patients may be either treatment-naïve; relapsed from; or refractory to prior therapy. (15 treatment-naïve and 15 relapsed/refractory patients will be enrolled)
  • Patients must have at least one site of disease that is accessible for intratumoral injection of PF-3512676 percutaneously
  • Tumor specimens must be available for immunological studies either from a previous biopsy or a new biopsy obtained before the initiation of the study.
  • Patients must have measurable disease other than the injection site or biopsy site.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status ≥ 1
  • Karnofsky Performance Status (KPS) of ≥ 70
  • ≥ 18 years of age
  • White blood cells (WBC) ≥ 2,000/uL
  • Platelet count ≥ 75,000/mm³
  • Absolute neutrophil count (ANC) ≥ 1000
  • Serum creatinine ≤ 2.0 mg/dL.
  • Bilirubin ≤ 1.5 mg/dL
  • Serum glutamic oxalocetic transaminase (SGOT) / serum glutamic pyruvic transaminase (SGPT) ratio < 3 x upper limit of normal (ULN)
  • Required wash out periods for prior therapy:

    • Topical therapy: 2 weeks
    • Chemotherapy: 4 weeks
    • Radiotherapy: 4 weeks
    • Other investigational therapy: 4 weeks
    • 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 a negative urine pregnancy test.
  • Life expectancy > 4 months.
  • Able to comply with the treatment schedule.
  • Ability to understand and the willingness to sign a written informed consent document.

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
    • Presence of autoantibodies without clinical autoimmune disease.
  • Known history of human immunodeficiency virus (HIV).
  • Patients with active infection or with a fever > 38.5 C within 3 days prior to the first scheduled treatment.
  • Central nervous system (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 PF-3512676
  • Current anticoagulant therapy [aspirin (ASA) ≤ 325 mg per day allowed]
  • Significant cardiovascular disease [ie, New York Heart Association (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: NCT00880581

Locations
United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Ronald Levy
Pfizer
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: NCT00880581     History of Changes
Other Study ID Numbers: IRB-14820
SU-03272009-2038 ( Other Identifier: SU IRB )
LYMNHL0064 ( Other Identifier: OnCore )
Study First Received: April 10, 2009
Results First Received: April 23, 2016
Last Updated: January 24, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

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

ClinicalTrials.gov processed this record on July 26, 2017