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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Ronald Levy, Stanford University
ClinicalTrials.gov Identifier:
NCT00880581
First received: April 10, 2009
Last updated: December 30, 2012
Last verified: December 2012
  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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II 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 Stanford University:

Primary Outcome Measures:
  • To determine local and systemic anti-tumor effects of intratumoral injection of CpG combined with local radiation in patients with low-grade B-cell lymphoma. [ Time Frame: 12 weeks after the initiation of therapy and q3monthly thereafter until progression. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To determine the feasibility and safety of this treatment regimen. [ Time Frame: 12 weeks after the initiation of therapy and q3monthly thereafter until progression. ] [ Designated as safety issue: Yes ]
  • To evaluate tumor-specific humoral and cellular immune responses. [ Time Frame: 12 weeks after the initiation of therapy and q3monthly thereafter until progression. ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: January 2009
Estimated Study Completion Date: September 2013
Primary Completion Date: September 2012 (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 Name: CpG
Radiation: Local radiotherapy
2 x 2 Gy

  Eligibility

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

Inclusion Criteria:1. Biopsy confirmed low-grade B-cell lymphoma, specifically, follicular grade 1 or 2, marginal zone or small lymphocytic lymphoma, of any initial stage. Patients may be either treatment-naïve or relapsed from or refractory to prior therapy. Fifteen treatment-naïve and 15 relapsed/refractory patients will be enrolled.

2. Patients must have at least one site of disease that is accessible for intratumoral injection of PF-3512676 percutaneously

3. Tumor specimens must be available for immunological studies either from a previous biopsy or a new biopsy obtained before the initiation of the study.

4. Patients must have measurable disease other than the injection site or biopsy site.

5. ECOG Performance Status of 1 or better (corresponds to Karnofsky Performance Status (KPS) of >= 70)

6. Patients must be 18 years of age or older.

7. Adequate bone marrow function: WBC >= 2,000/uL; platelet count >= 75,000/mm3; ANC>= 1000.

8. Adequate renal function: serum creatinine <= 2.0mg/dL.

9. Adequate hepatic function: bilirubin <=1.5 mg/dL; SGOT/SGPT < 3 x upper limit of normal

10.Required wash out periods for prior therapy:

  1. Topical therapy: 2 weeks
  2. Chemotherapy: 4 weeks
  3. Radiotherapy: 4 weeks
  4. Other investigational therapy: 4 weeks
  5. Rituximab: 12 weeks

    11.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.

    12.Women of reproductive potential must have negative urine pregnancy test. 13.Life expectancy greater than 4 months. 14.Able to comply with the treatment schedule. 15.Ability to understand and the willingness to sign a written informed consent document.

    Exclusion Criteria:A patient may not be enrolled in the trial if any of the following criteria are met:

    1. 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.
    2. Known history of human immunodeficiency virus (HIV).
    3. Patients with active infection or with a fever >38.50 C within three days prior to the first scheduled treatment.
    4. CNS metastases
    5. 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.
    6. History of allergic reactions attributed to compounds of similar composition to PF-3512676
    7. Current anticoagulant therapy (ASA <= 325 mg per day allowed).
    8. 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).
    9. Pregnant or lactating.
    10. 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.

    The principal investigator may grant a protocol exemption in cases where a patient would be ineligible based on one or more exclusion criteria but would be a good candidate for the study. In this case, a note to file must be generated to explain the inclusion of the patient.

  Contacts and Locations
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

No publications provided

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: LYMNHL0064, SU-03272009-2038, 14820
Study First Received: April 10, 2009
Last Updated: December 30, 2012
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on April 17, 2014