CPG 7909 in Patients With Cutaneous T-Cell Lymphoma

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NCT00043420

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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) < 60 will be
excluded.

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T-Cell LymphomaCPG 7909 in Patients With Cutaneous T-Cell Lymphoma NCT00043420
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE CPG 7909 in Patients With Cutaneous T-Cell Lymphoma
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Lymphoma, T-Cell, Cutaneous
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
Publications * 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.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 16, 2006)		42
Original Enrollment  ICMJE
 (submitted: June 23, 2005)		48
Actual Study Completion Date  ICMJE March 2007
Actual Primary Completion Date March 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries United States
 
Administrative Information
NCT Number  ICMJE NCT00043420
Other Study ID Numbers  ICMJE C014
CO14, A8501014
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date February 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP