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CPG 7909 in Patients With Cutaneous T-Cell Lymphoma

Sponsor
Pfizer (Industry)
Overall Status
Completed
CT.gov ID
NCT00043420
Collaborator
(none)
42
Enrollment
8
Arms
49.9
Duration (Months)

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 1/Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
42 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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 Start Date :
Jan 1, 2003
Actual Primary Completion Date :
Mar 1, 2007
Actual Study Completion Date :
Mar 1, 2007

Arms and Interventions

Arm Intervention/Treatment
Experimental: Phase I: 0.08 mg/kg

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

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 Names:
  • ProMune, CPG 7909

    		•
    Experimental: Phase I: 0.16 mg/kg

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

    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 Names:
  • ProMune, CPG 7909

    		•
    Experimental: Phase I: 0.24 mg/kg

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

    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 Names:
  • ProMune, CPG 7909

    		•
    Experimental: Phase I: 0.28 mg/kg

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

    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 Names:
  • ProMune, CPG 7909

    		•
    Experimental: Phase I: 0.32 mg/kg

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

    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 Names:
  • ProMune, CPG 7909

    		•
    Experimental: Phase I: 0.36 mg/kg

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

    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 Names:
  • ProMune, CPG 7909

    		•
    Experimental: Phase II: 10 mg

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

    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 Names:
  • ProMune, CPG 7909

    		•
    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.

    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 Names:
  • ProMune, CPG 7909

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Safety: Adverse events, vital signs, clinical and laboratory parameters, physical exams, and ECGs [24 weeks]

    2. 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. [24 weeks]

    Secondary Outcome Measures

    1. 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. [indeterminate]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Pfizer

    Investigators

    • Study Director: Pfizer CT.gov Call Center, Pfizer

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00043420
    Other Study ID Numbers:
    • C014
    • CO14, A8501014
    • NCT00091208
    First Posted:
    Aug 12, 2002
    Last Update Posted:
    Feb 12, 2009
    Last Verified:
    Feb 1, 2009
    Keywords provided by , ,
    immunotherapy, lymphoma
    Additional relevant MeSH terms:
    Lymphoma
    Lymphoma, T-Cell
    Lymphoma, T-Cell, Cutaneous

    Study Results

    No Results Posted as of Feb 12, 2009