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CPG 7909 in Patients With Cutaneous T-Cell Lymphoma

Last updated on August 9, 2018

FOR MORE INFORMATION
Study Location
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
T-Cell Lymphoma
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

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

Patients with visceral involvement, serious infection or illness including human
immunodeficiency virus infection, or a Karnofsky Performance Status (KPS) excluded.

NCT00043420
Pfizer
Completed
CPG 7909 in Patients With Cutaneous T-Cell Lymphoma

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Similar Trials

CPG 7909 in Patients With Cutaneous T-Cell Lymphoma
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
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.
Not Provided
Interventional
Phase 1
Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Lymphoma, T-Cell, Cutaneous
  • Drug: PF-3512676
    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.
    Other Name: ProMune, CPG 7909
  • Drug: PF-3512676
    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.
    Other Name: ProMune, CPG 7909
  • Drug: PF-3512676
    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.
    Other Name: ProMune, CPG 7909
  • Drug: PF-3512676
    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.
    Other Name: ProMune, CPG 7909
  • Drug: PF-3512676
    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.
    Other Name: ProMune, CPG 7909
  • Drug: PF-3512676
    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.
    Other Name: ProMune, CPG 7909
  • Drug: PF-3512676
    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.
    Other Name: ProMune, CPG 7909
  • Drug: PF-3512676
    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.
    Other Name: ProMune, CPG 7909
  • Experimental: Phase I: 0.08 mg/kg
    Escalating dose groups: 0.08 mg/kg PF-3512676 Injection
    Intervention: Drug: PF-3512676
  • Experimental: Phase I: 0.16 mg/kg
    Escalating dose groups: 0.16 mg/kg PF-3512676 Injection
    Intervention: Drug: PF-3512676
  • Experimental: Phase I: 0.24 mg/kg
    Escalating dose groups: 0.24 mg/kg PF-3512676 Injection
    Intervention: Drug: PF-3512676
  • Experimental: Phase I: 0.28 mg/kg
    Escalating dose groups: 0.28 mg/kg PF-3512676 Injection
    Intervention: Drug: PF-3512676
  • Experimental: Phase I: 0.32 mg/kg
    Escalating dose groups: 0.32 mg/kg PF-3512676 Injection
    Intervention: Drug: PF-3512676
  • Experimental: Phase I: 0.36 mg/kg
    Escalating dose groups: 0.36 mg/kg PF-3512676 Injection
    Intervention: Drug: PF-3512676
  • Experimental: Phase II: 10 mg
    Phase II: 10 mg flat dose (random assignment in Phase II)
    Intervention: Drug: PF-3512676
  • Experimental: Phase II: 25 mg
    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: Drug: PF-3512676
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.


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
42
March 2007
March 2007   (Final data collection date for primary outcome measure)

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.

Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
United States
 
NCT00043420
C014
CO14, A8501014
No
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
February 2009

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



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