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Sponsored by: |
Pfizer |
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Information provided by: | Pfizer |
ClinicalTrials.gov Identifier: | NCT00043420 |
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 | Intervention | Phase |
---|---|---|
Lymphoma, T-Cell, Cutaneous |
Drug: PF-3512676 |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study |
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 |
Enrollment: | 42 |
Study Start Date: | January 2003 |
Study Completion Date: | March 2007 |
Primary Completion Date: | March 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Phase I: 0.08 mg/kg: Experimental
Escalating dose groups: 0.08 mg/kg PF-3512676 Injection
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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.
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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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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.
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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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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.
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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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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.
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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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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.
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Phase I: 0.36 mg/kg: Experimental
Escalating dose groups: 0.36 mg/kg PF-3512676 Injection
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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.
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Phase II: 10 mg: Experimental
Phase II: 10 mg flat dose (random assignment in Phase II)
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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.
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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.
|
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.
|
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
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.
Responsible Party: | Pfizer, Inc. ( Director, Clinical Trial Disclosure Group ) |
Study ID Numbers: | C014, CO14, A8501014 |
Study First Received: | August 8, 2002 |
Last Updated: | February 11, 2009 |
ClinicalTrials.gov Identifier: | NCT00043420 History of Changes |
Health Authority: | United States: Food and Drug Administration |
immunotherapy, lymphoma |
Lymphatic Diseases Mycoses Immunoproliferative Disorders Cutaneous T-cell Lymphoma Lymphoma, T-Cell Sezary Syndrome |
Mycosis Fungoides Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Lymphoma Lymphoma, T-Cell, Cutaneous |
Lymphatic Diseases Neoplasms Immunoproliferative Disorders Neoplasms by Histologic Type Immune System Diseases Lymphoma, T-Cell |
Sezary Syndrome Mycosis Fungoides Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Lymphoma Lymphoma, T-Cell, Cutaneous |