CPG 7909 in Patients With Cutaneous T-Cell Lymphoma
February 11, 2009 updated by: Pfizer
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
42
Phase
- Phase 2
- Phase 1
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Phase I: 0.08 mg/kg
Escalating dose groups: 0.08 mg/kg PF-3512676 Injection
|
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:
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:
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:
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:
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:
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:
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:
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:
|
|
Experimental: Phase I: 0.16 mg/kg
Escalating dose groups: 0.16 mg/kg PF-3512676 Injection
|
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:
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:
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:
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:
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:
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:
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:
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:
|
|
Experimental: Phase I: 0.24 mg/kg
Escalating dose groups: 0.24 mg/kg PF-3512676 Injection
|
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:
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:
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:
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:
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:
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:
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:
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:
|
|
Experimental: Phase I: 0.28 mg/kg
Escalating dose groups: 0.28 mg/kg PF-3512676 Injection
|
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:
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:
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:
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:
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:
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:
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:
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:
|
|
Experimental: Phase I: 0.32 mg/kg
Escalating dose groups: 0.32 mg/kg PF-3512676 Injection
|
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:
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:
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:
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:
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:
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:
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:
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:
|
|
Experimental: Phase I: 0.36 mg/kg
Escalating dose groups: 0.36 mg/kg PF-3512676 Injection
|
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:
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:
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:
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:
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:
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:
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:
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:
|
|
Experimental: Phase II: 10 mg
Phase II: 10 mg flat dose (random assignment in Phase II)
|
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:
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:
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:
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:
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:
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:
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:
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:
|
|
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.
|
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:
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:
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:
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:
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:
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:
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:
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:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Safety: Adverse events, vital signs, clinical and laboratory parameters, physical exams, and ECGs
Time Frame: 24 weeks
|
24 weeks
|
|
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
|
24 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
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
|
indeterminate
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2003
Primary Completion (Actual)
March 1, 2007
Study Completion (Actual)
March 1, 2007
Study Registration Dates
First Submitted
August 8, 2002
First Submitted That Met QC Criteria
August 9, 2002
First Posted (Estimate)
August 12, 2002
Study Record Updates
Last Update Posted (Estimate)
February 12, 2009
Last Update Submitted That Met QC Criteria
February 11, 2009
Last Verified
February 1, 2009
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- C014
- CO14, A8501014
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.