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| ID | Type | Description | Link |
|---|---|---|---|
| CO14, A8501014 |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase I: 0.08 mg/kg | Experimental | Escalating dose groups: 0.08 mg/kg PF-3512676 Injection |
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| Phase I: 0.16 mg/kg | Experimental | Escalating dose groups: 0.16 mg/kg PF-3512676 Injection |
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| Phase I: 0.24 mg/kg | Experimental | Escalating dose groups: 0.24 mg/kg PF-3512676 Injection |
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| Phase I: 0.28 mg/kg | Experimental | Escalating dose groups: 0.28 mg/kg PF-3512676 Injection |
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| Phase I: 0.32 mg/kg | Experimental | Escalating dose groups: 0.32 mg/kg PF-3512676 Injection |
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| Phase I: 0.36 mg/kg | Experimental | Escalating dose groups: 0.36 mg/kg PF-3512676 Injection |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-3512676 | Drug | 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. |
| 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 |
| 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 |
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32632956 | Derived | 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. | |
| 20888065 | Derived | 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. |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| ID | Term |
|---|---|
| D016410 | Lymphoma, T-Cell, Cutaneous |
| D008223 | Lymphoma |
| ID | Term |
|---|---|
| D016399 | Lymphoma, T-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C483020 | ProMune |
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| Phase II: 10 mg | Experimental | Phase II: 10 mg flat dose (random assignment in Phase II) |
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| Phase II: 25 mg | Experimental | 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. |
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| PF-3512676 | Drug | 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. |
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| PF-3512676 | Drug | 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. |
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| PF-3512676 | Drug | 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. |
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| PF-3512676 | Drug | 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. |
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| PF-3512676 | Drug | 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. |
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| PF-3512676 | Drug | 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. |
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| PF-3512676 | Drug | 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. |
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| D008232 |
| Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |