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

NCT00880581

Last updated date
Study Location
Stanford University School of Medicine
Stanford, California, 94305, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Non-Hodgkin Lymphoma, Lymphoma, Lymphomas: Non-Hodgkin Follicular / Indolent B-Cell, Lymphomas: Non-Hodgkin
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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.

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Non-Hodgkin Lymphoma, Lymphoma, Lymphomas: Non-Hodgkin Follicular / Indolent B-Cell, Lymphomas: Non-HodgkinA Phase 2 Intratumoral Injection PF-3512676 Plus Local Radiation in Low-Grade B-Cell Lymphomas
NCT00880581
  1. Stanford, California
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE A Phase 2 Intratumoral Injection PF-3512676 Plus Local Radiation in Low-Grade B-Cell Lymphomas
Official Title  ICMJE A Phase 2 Study of Intratumoral Injection PF-3512676 in Combination With Local Radiation in Low-Grade B-Cell Lymphomas
Brief Summary To assess the feasibility of using intra-tumoral PF-3512676 in combination with local radiation as a therapy for lowgrade b-cell lymphoma.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Lymphoma, Non-Hodgkin
  • Lymphoma
  • Lymphomas: Non-Hodgkin Follicular / Indolent B-Cell
  • Lymphomas: Non-Hodgkin
Intervention  ICMJE
  • 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
Study Arms  ICMJE 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.
Interventions:
  • Drug: PF-3512676
  • Radiation: Local radiotherapy
Publications * Cheson BD, Horning SJ, Coiffier B, Shipp MA, Fisher RI, Connors JM, Lister TA, Vose J, Grillo-López A, Hagenbeek A, Cabanillas F, Klippensten D, Hiddemann W, Castellino R, Harris NL, Armitage JO, Carter W, Hoppe R, Canellos GP. Report of an international workshop to standardize response criteria for non-Hodgkin's lymphomas. NCI Sponsored International Working Group. J Clin Oncol. 1999 Apr;17(4):1244. Review. Erratum in: J Clin Oncol 2000 Jun;18(11):2351.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 13, 2009)
30
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 2015
Actual Primary Completion Date September 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00880581
Other Study ID Numbers  ICMJE IRB-14820
SU-03272009-2038 ( Other Identifier: SU IRB )
LYMNHL0064 ( Other Identifier: OnCore )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD:No
Responsible Party Ronald Levy, Stanford University
Study Sponsor  ICMJE Ronald Levy
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Principal Investigator:Ronald LevyStanford University
PRS Account Stanford University
Verification Date January 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP