NCT00185965

Brief Summary

Brief summary TBD

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jul 2004

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2004

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 16, 2005

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
4.4 years until next milestone

Results Posted

Study results publicly available

August 1, 2014

Completed
Last Updated

August 1, 2014

Status Verified

July 1, 2014

Enrollment Period

5.7 years

First QC Date

September 12, 2005

Results QC Date

July 7, 2014

Last Update Submit

July 7, 2014

Conditions

Non-Hodgkin LymphomaMycosis Fungoides

Keywords

non-Hodgkinlymphomamycosisfungoides

Outcome Measures

Primary Outcomes (1)

  • Objective Response Rate (ORR)

    Objective Response Rate (ORR) consisting of Complete Response (CR) + Partial Response (PR), not including Stable Disease (SD)

    12 weeks

Study Arms (2)

Lymphoma, B-cell low-grade (BCL)

EXPERIMENTAL

Recurrent low-grade B-cell lymphoma patients (at least one prior treatment failure)

Drug: CPG 7909

Mycosis fungoides (MF)

EXPERIMENTAL

Mycosis fungoides patients must have failed or have been intolerant of at least 1 topical or 1 systemic treatment Recurrent mycosis fungoides patients (at least one prior failure of topical or systemic treatment)

Drug: CPG 7909

Interventions

CPG 7909DRUG

6 mg intratumoral injection, administered immediately before 2 Gy radiotherapy (RT) to a designated tumor lesion, about 24 hours later after a 2nd 2 Gy RT dose, then weekly for 8 additional weeks (total of 10 injections).

Also known as: PF-3512676, CPG-enriched TLR9 agonist, CPG
Lymphoma, B-cell low-grade (BCL)Mycosis fungoides (MF)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Biopsy confirmed low-grade B-cell lymphoma of any initial stage or mycosis fungoides of stage IB-IVA. B-cell lymphoma patients must have failed at least one prior treatment. Mycosis fungoides patients must have failed or have been intolerant of at least 2 topical or one systemic treatment.
  • Patients must have at least one site of disease that is accessible for intratumoral injection of CpG percutaneously
  • Tumor specimens must be available for immunological studies either from a previous biopsy or a new biopsy obtained before the initiation of the treatment.
  • Patients must have measurable disease other than the injection site or biopsy site.
  • years of age or older
  • Karnofsky Performance Status (KPS) of \> 70.
  • Adequate bone marrow function: WBC\>4,000uL, hemoglobin \> 10g/dL; platelet count \>100,000/mm3; ANC\> 1000.
  • Adequate hepatic function: bilirubin \<= 1.5 mg/dL; SGOT/SGPT\<3xupper limit of normal
  • Adequate renal function: serum creatinine \<= 2.0mg/dL.
  • Required wash out periods for prior therapy:
  • Topical therapy: 2 weeks
  • Chemotherapy: 4 weeks
  • Radiotherapy (including photo therapy): 4 weeks
  • Systemic biological therapy for mycosis fungoides: 4 weeks
  • Other investigational therapy: 4weeks
  • +5 more criteria

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, or the presence of autoantibodies without clinical autoimmune disease.
  • Known history of human immunodeficiency virus (HIV), hepatitis B or hepatitis C (active, prior treatment, or both).
  • Patients with active infection or with a fever \>38.50 C within three days prior to the first scheduled treatment.
  • 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 CpG 7909
  • Current anticoagulant therapy (ASA\<= 325mg/day allowed).
  • 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).
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

Related Publications (2)

  • Kim YH, Gratzinger D, Harrison C, Brody JD, Czerwinski DK, Ai WZ, Morales A, Abdulla F, Xing L, Navi D, Tibshirani RJ, Advani RH, Lingala B, Shah S, Hoppe RT, Levy R. In situ vaccination against mycosis fungoides by intratumoral injection of a TLR9 agonist combined with radiation: a phase 1/2 study. Blood. 2012 Jan 12;119(2):355-63. doi: 10.1182/blood-2011-05-355222. Epub 2011 Nov 1.

    PMID: 22045986RESULT

  • Brody JD, Ai WZ, Czerwinski DK, Torchia JA, Levy M, Advani RH, Kim YH, Hoppe RT, Knox SJ, Shin LK, Wapnir I, Tibshirani RJ, Levy R. In situ vaccination with a TLR9 agonist induces systemic lymphoma regression: a phase I/II study. J Clin Oncol. 2010 Oct 1;28(28):4324-32. doi: 10.1200/JCO.2010.28.9793. Epub 2010 Aug 9.

    PMID: 20697067RESULT

MeSH Terms

Conditions

Lymphoma, Non-HodgkinMycosis FungoidesLymphomaMycoses

Interventions

ProMune

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLymphoma, T-Cell, CutaneousLymphoma, T-CellBacterial Infections and MycosesInfections

Results Point of Contact

Title
Ronald Levy, MD / Robert K and Helen K Summy Professor of Medicine
Organization
School of Medicine, Stanford University
levy@stanford.edu
650-725-6452

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 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
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

September 12, 2005

First Posted

September 16, 2005

Study Start

July 1, 2004

Primary Completion

March 1, 2010

Study Completion

March 1, 2010

Last Updated

August 1, 2014

Results First Posted

August 1, 2014

Record last verified: 2014-07

Locations

US(1)