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CPG 7909 in Patients With Cutaneous T-Cell Lymphoma

Primary Purpose

Lymphoma, T-Cell, Cutaneous

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
PF-3512676
PF-3512676
PF-3512676
PF-3512676
PF-3512676
PF-3512676
PF-3512676
PF-3512676
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphoma, T-Cell, Cutaneous focused on measuring immunotherapy, lymphoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients 18 years or older with biopsy (histopathologically) confirmed cutaneous T-cell lymphoma (limited to mycosis fungoides (MF)) who have had prior therapy with at least one and no more than 3 systemic treatments. Exclusion Criteria: Patients with visceral involvement, serious infection or illness including human immunodeficiency virus infection, or a Karnofsky Performance Status (KPS) < 60 will be excluded.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm 5

    Arm 6

    Arm 7

    Arm 8

    Arm Type

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Arm Label

    Phase I: 0.08 mg/kg

    Phase I: 0.16 mg/kg

    Phase I: 0.24 mg/kg

    Phase I: 0.28 mg/kg

    Phase I: 0.32 mg/kg

    Phase I: 0.36 mg/kg

    Phase II: 10 mg

    Phase II: 25 mg

    Arm Description

    Escalating dose groups: 0.08 mg/kg PF-3512676 Injection

    Escalating dose groups: 0.16 mg/kg PF-3512676 Injection

    Escalating dose groups: 0.24 mg/kg PF-3512676 Injection

    Escalating dose groups: 0.28 mg/kg PF-3512676 Injection

    Escalating dose groups: 0.32 mg/kg PF-3512676 Injection

    Escalating dose groups: 0.36 mg/kg PF-3512676 Injection

    Phase II: 10 mg flat dose (random assignment in Phase II)

    Weekly subcutaneous injections of 25 mg PF-3512676. Treatment continues for a minimum of 8 weeks unless disease progression or unacceptable toxicity occurs, or a maximum of 24 weeks.

    Outcomes

    Primary Outcome Measures

    Safety: Adverse events, vital signs, clinical and laboratory parameters, physical exams, and ECGs
    Efficacy: Evaluate tumor response as measured by the Composite Assessment of Index Lesion Disease Severity (CA). The primary endpoint will be the overall tumor response rate as assessed by the CA.

    Secondary Outcome Measures

    Secondary efficacy endpoints include disease response assessed by the PGA, duration of overall response, duration of CCR, duration of PR, time to response and time to progression of disease.

    Full Information

    First Posted
    August 8, 2002
    Last Updated
    February 11, 2009
    Sponsor
    Pfizer
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00043420
    Brief Title
    CPG 7909 in Patients With Cutaneous T-Cell Lymphoma
    Official Title
    A Phase I/II Open Label, Multi-Center Study For The Evaluation Of Pf-3512676 (CPG 7909) In Patients With Stage Ib To Iva Cutaneous T-Cell Lymphoma
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2009
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2003 (undefined)
    Primary Completion Date
    March 2007 (Actual)
    Study Completion Date
    March 2007 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Pfizer

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    To assess the effect of CPG 7909 Injection on Cutaneous T-cell lymphoma and the safety of CPG 7909 Injection in patients with this cancer.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Lymphoma, T-Cell, Cutaneous
    Keywords
    immunotherapy, lymphoma

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1, Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    42 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Phase I: 0.08 mg/kg
    Arm Type
    Experimental
    Arm Description
    Escalating dose groups: 0.08 mg/kg PF-3512676 Injection
    Arm Title
    Phase I: 0.16 mg/kg
    Arm Type
    Experimental
    Arm Description
    Escalating dose groups: 0.16 mg/kg PF-3512676 Injection
    Arm Title
    Phase I: 0.24 mg/kg
    Arm Type
    Experimental
    Arm Description
    Escalating dose groups: 0.24 mg/kg PF-3512676 Injection
    Arm Title
    Phase I: 0.28 mg/kg
    Arm Type
    Experimental
    Arm Description
    Escalating dose groups: 0.28 mg/kg PF-3512676 Injection
    Arm Title
    Phase I: 0.32 mg/kg
    Arm Type
    Experimental
    Arm Description
    Escalating dose groups: 0.32 mg/kg PF-3512676 Injection
    Arm Title
    Phase I: 0.36 mg/kg
    Arm Type
    Experimental
    Arm Description
    Escalating dose groups: 0.36 mg/kg PF-3512676 Injection
    Arm Title
    Phase II: 10 mg
    Arm Type
    Experimental
    Arm Description
    Phase II: 10 mg flat dose (random assignment in Phase II)
    Arm Title
    Phase II: 25 mg
    Arm Type
    Experimental
    Arm Description
    Weekly subcutaneous injections of 25 mg PF-3512676. Treatment continues for a minimum of 8 weeks unless disease progression or unacceptable toxicity occurs, or a maximum of 24 weeks.
    Intervention Type
    Drug
    Intervention Name(s)
    PF-3512676
    Other Intervention Name(s)
    ProMune, CPG 7909
    Intervention Description
    Weekly subcutaneous injections of 0.08mg/kg PF-3512676. Treatment continues for a minimum of 8 weeks unless disease progression or unacceptable toxicity occurs, or a maximum of 24 weeks.
    Intervention Type
    Drug
    Intervention Name(s)
    PF-3512676
    Other Intervention Name(s)
    ProMune, CPG 7909
    Intervention Description
    Weekly subcutaneous injections of 0.16mg/kg PF-3512676. Treatment continues for a minimum of 8 weeks unless disease progression or unacceptable toxicity occurs, or a maximum of 24 weeks.
    Intervention Type
    Drug
    Intervention Name(s)
    PF-3512676
    Other Intervention Name(s)
    ProMune, CPG 7909
    Intervention Description
    Weekly subcutaneous injections of 0.24mg/kg PF-3512676. Treatment continues for a minimum of 8 weeks unless disease progression or unacceptable toxicity occurs, or a maximum of 24 weeks.
    Intervention Type
    Drug
    Intervention Name(s)
    PF-3512676
    Other Intervention Name(s)
    ProMune, CPG 7909
    Intervention Description
    Weekly subcutaneous injections of 0.28mg/kg PF-3512676. Treatment continues for a minimum of 8 weeks unless disease progression or unacceptable toxicity occurs, or a maximum of 24 weeks.
    Intervention Type
    Drug
    Intervention Name(s)
    PF-3512676
    Other Intervention Name(s)
    ProMune, CPG 7909
    Intervention Description
    Weekly subcutaneous injections of 0.32mg/kg PF-3512676. Treatment continues for a minimum of 8 weeks unless disease progression or unacceptable toxicity occurs, or a maximum of 24 weeks.
    Intervention Type
    Drug
    Intervention Name(s)
    PF-3512676
    Other Intervention Name(s)
    ProMune, CPG 7909
    Intervention Description
    Weekly subcutaneous injections of 0.36mg/kg PF-3512676. Treatment continues for a minimum of 8 weeks unless disease progression or unacceptable toxicity occurs, or a maximum of 24 weeks.
    Intervention Type
    Drug
    Intervention Name(s)
    PF-3512676
    Other Intervention Name(s)
    ProMune, CPG 7909
    Intervention Description
    Weekly subcutaneous injections of 10 mg PF-3512676. Treatment continues for a minimum of 8 weeks unless disease progression or unacceptable toxicity occurs, or a maximum of 24 weeks.
    Intervention Type
    Drug
    Intervention Name(s)
    PF-3512676
    Other Intervention Name(s)
    ProMune, CPG 7909
    Intervention Description
    Weekly subcutaneous injections of 25 mg PF-3512676. Treatment continues for a minimum of 8 weeks unless disease progression or unacceptable toxicity occurs, or a maximum of 24 weeks.
    Primary Outcome Measure Information:
    Title
    Safety: Adverse events, vital signs, clinical and laboratory parameters, physical exams, and ECGs
    Time Frame
    24 weeks
    Title
    Efficacy: Evaluate tumor response as measured by the Composite Assessment of Index Lesion Disease Severity (CA). The primary endpoint will be the overall tumor response rate as assessed by the CA.
    Time Frame
    24 weeks
    Secondary Outcome Measure Information:
    Title
    Secondary efficacy endpoints include disease response assessed by the PGA, duration of overall response, duration of CCR, duration of PR, time to response and time to progression of disease.
    Time Frame
    indeterminate

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients 18 years or older with biopsy (histopathologically) confirmed cutaneous T-cell lymphoma (limited to mycosis fungoides (MF)) who have had prior therapy with at least one and no more than 3 systemic treatments. Exclusion Criteria: Patients with visceral involvement, serious infection or illness including human immunodeficiency virus infection, or a Karnofsky Performance Status (KPS) < 60 will be excluded.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Pfizer CT.gov Call Center
    Organizational Affiliation
    Pfizer
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    32632956
    Citation
    Valipour A, Jager M, Wu P, Schmitt J, Bunch C, Weberschock T. Interventions for mycosis fungoides. Cochrane Database Syst Rev. 2020 Jul 7;7(7):CD008946. doi: 10.1002/14651858.CD008946.pub3.
    Results Reference
    derived
    PubMed Identifier
    20888065
    Citation
    Kim YH, Girardi M, Duvic M, Kuzel T, Link BK, Pinter-Brown L, Rook AH. Phase I trial of a Toll-like receptor 9 agonist, PF-3512676 (CPG 7909), in patients with treatment-refractory, cutaneous T-cell lymphoma. J Am Acad Dermatol. 2010 Dec;63(6):975-83. doi: 10.1016/j.jaad.2009.12.052.
    Results Reference
    derived
    Links:
    URL
    https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=CO14&StudyName=CPG%207909%20in%20Patients%20With%20Cutaneous%20T-Cell%20Lymphoma
    Description
    To obtain contact information for a study center near you, click here.

    Learn more about this trial

    CPG 7909 in Patients With Cutaneous T-Cell Lymphoma

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