| CPG 7909 in Patients With Cutaneous T-Cell Lymphoma |
| 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. |
| Not Provided |
| Interventional |
Phase 1
Phase 2 |
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment |
| Lymphoma, T-Cell, Cutaneous |
- 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
|
- 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
|
| 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. |
| |
| Completed |
| 42 |
| March 2007 |
| March 2007 (Final data collection date for primary outcome measure) |
|
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.
|
| Sexes Eligible for Study: |
All |
|
| 18 Years and older (Adult, Senior) |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| Not Provided |
| United States |
| |
| NCT00043420 |
C014
CO14, A8501014 |
| No |
| Not Provided |
| Not Provided |
| Director, Clinical Trial Disclosure Group, Pfizer, Inc. |
| Pfizer |
| Not Provided |
| Study Director: |
Pfizer CT.gov Call Center |
Pfizer |
|
| Pfizer |
| February 2009 |
