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

NCT00880581 | Completed Phase 2 Results DMC FDA Drug

• 3 other identifiers: IRB-14820SU-03272009-2038LYMNHL0064
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Lymphoma, Non-Hodgkin; Lymphoma; Lymphomas: Non-Hodgkin Follicular / Indolent B-Cell; Lymphomas: Non-Hodgkin

Outcome Measures

Primary Outcomes (1)

• Overall ObjectiveResponse (ORR) Rate

  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.

  12 weeks

Secondary Outcomes (1)

• Response Rate After Cycle 2

  6 months

Study Arms (1)

PF-3512676

EXPERIMENTAL

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; Radiation: Local radiotherapy

Interventions

PF-3512676 DRUG

18 mg injection

Also known as: CpG 7909, CpG, ProMune

PF-3512676

Local radiotherapy RADIATION

2 gray (2 Gy) on each of Days 1 and 2

PF-3512676

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ronald Levy: lead
• Pfizer: collaborator

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

Related Publications (1)

• Cheson BD, Horning SJ, Coiffier B, Shipp MA, Fisher RI, Connors JM, Lister TA, Vose J, Grillo-Lopez 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. doi: 10.1200/JCO.1999.17.4.1244.

  PMID: 10561185 BACKGROUND

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin; Lymphoma

Interventions

ProMune

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Results Point of Contact

• Title: Ronald Levy
• Organization: Stanford University

levy@stanford.edu

6507256452

Study Officials

• Ronald Levy

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Robert K. and Helen K. Summy Professor in the School of Medicine

Study Record Dates

• First Submitted: April 10, 2009
• First Posted: April 14, 2009
• Study Start: January 1, 2009
• Primary Completion: September 1, 2011
• Study Completion: January 1, 2015
• Last Updated: March 14, 2017
• Results First Posted: March 14, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)