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Lymphoma, Non-HodgkinPhase 2NCT00880581

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

A Phase 2 study testing PF-3512676 and Local radiotherapy in people with Lymphoma, Non-Hodgkin and Lymphoma, run by Ronald Levy at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

To assess the feasibility of using intra-tumoral PF-3512676 in combination with local radiation as a therapy for lowgrade b-cell lymphoma. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
PF-3512676 and Local radiotherapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteUnited States
Study dates
Jan 2009to Jan 2015
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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.

Who cannot join

  • 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
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  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Stanford University School of Medicine

    Stanford, California, 94305

Other trials in United States

About this study

Official title: A Phase 2 Study of Intratumoral Injection PF-3512676 in Combination With Local Radiation in Low-Grade B-Cell Lymphomas

To assess the feasibility of using intra-tumoral PF-3512676 in combination with local radiation as a therapy for lowgrade b-cell lymphoma.

Being tested
PF-3512676, Local radiotherapy
Medical subject headings
Lymphoma, Non-Hodgkin, Lymphoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PF-3512676Drug

    Also called CpG 7909, CpG, ProMune

    18 mg injection

  • Local radiotherapyRadiation

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

Study groups in NCT00880581
Study groupRoleWhat they receive
PF-3512676ExperimentalPatients 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.
Receives: Drug: PF-3512676; Radiation: Local radiotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 12 weeks

Secondary outcomes (1)

  1. Response Rate After Cycle 2

    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.

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Apr 2009 (estimated)
  2. Study startJan 2009
  3. Primary completionSep 2011
  4. Study completionJan 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00880581
Sponsor's protocol ID
IRB-14820
Other IDs
SU-03272009-2038, LYMNHL0064
Status last verified
Jan 2017
First submitted
10 Apr 2009
Last updated
14 Mar 2017
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 10561185

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing PF-3512676 and Local radiotherapy in people with Lymphoma, Non-Hodgkin and Lymphoma, run by Ronald Levy at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 25 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Mar 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall ObjectiveResponse (ORR) Rate (time frame: 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00880581, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2017.

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