CPG 7909 in Patients With Cutaneous T-Cell Lymphoma

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Lymphoma, T-Cell, Cutaneous

Intervention / Treatment
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* Drug: PF-3512676
* Drug: PF-3512676
* Drug: PF-3512676
* Drug: PF-3512676
* Drug: PF-3512676
* Drug: PF-3512676
* Drug: PF-3512676
* Drug: PF-3512676


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Phase I: 0.08 mg/kg<br>Escalating dose groups: 0.08 mg/kg PF-3512676 Injection | Drug: PF-3512676<br>* 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.<br>* Other names: ProMune, CPG 7909;|
| Experimental: Phase I: 0.16 mg/kg<br>Escalating dose groups: 0.16 mg/kg PF-3512676 Injection | Drug: PF-3512676<br>* 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.<br>* Other names: ProMune, CPG 7909;|
| Experimental: Phase I: 0.24 mg/kg<br>Escalating dose groups: 0.24 mg/kg PF-3512676 Injection | Drug: PF-3512676<br>* 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.<br>* Other names: ProMune, CPG 7909;|
| Experimental: Phase I: 0.28 mg/kg<br>Escalating dose groups: 0.28 mg/kg PF-3512676 Injection | Drug: PF-3512676<br>* 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.<br>* Other names: ProMune, CPG 7909;|
| Experimental: Phase I: 0.32 mg/kg<br>Escalating dose groups: 0.32 mg/kg PF-3512676 Injection | Drug: PF-3512676<br>* 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.<br>* Other names: ProMune, CPG 7909;|
| Experimental: Phase I: 0.36 mg/kg<br>Escalating dose groups: 0.36 mg/kg PF-3512676 Injection | Drug: PF-3512676<br>* 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.<br>* Other names: ProMune, CPG 7909;|
| Experimental: Phase II: 10 mg<br>Phase II: 10 mg flat dose (random assignment in Phase II) | Drug: PF-3512676<br>* 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.<br>* Other names: ProMune, CPG 7909;|
| Experimental: Phase II: 25 mg<br>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<br>* 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.<br>* Other names: ProMune, CPG 7909;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety: Adverse events, vital signs, clinical and laboratory parameters, physical exams, and ECGs |  | 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. |  | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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. |  | indeterminate | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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immunotherapy, lymphoma