CPG 7909 in Patients With Cutaneous T-Cell Lymphoma

Pfizer

Status and phase: Completed; Phase 2; Phase 1

Conditions: Lymphoma, T-Cell, Cutaneous

Treatments: Drug: PF-3512676

Study type: Interventional

Funder types: Industry

Identifiers

NCT00043420

C014

CO14, A8501014

Details and patient eligibility

About

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.

Enrollment: 42 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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42 participants in 8 patient groups

Phase I: 0.08 mg/kg

Experimental group

Description:

Escalating dose groups: 0.08 mg/kg PF-3512676 Injection

Treatment:

Drug: PF-3512676

Drug: PF-3512676

Drug: PF-3512676

Drug: PF-3512676

Drug: PF-3512676

Drug: PF-3512676

Drug: PF-3512676

Drug: PF-3512676

Phase I: 0.16 mg/kg

Experimental group

Description:

Escalating dose groups: 0.16 mg/kg PF-3512676 Injection

Treatment:

Drug: PF-3512676

Drug: PF-3512676

Drug: PF-3512676

Drug: PF-3512676

Drug: PF-3512676

Drug: PF-3512676

Drug: PF-3512676

Drug: PF-3512676

Phase I: 0.24 mg/kg

Experimental group

Description:

Escalating dose groups: 0.24 mg/kg PF-3512676 Injection

Treatment:

Drug: PF-3512676

Drug: PF-3512676

Drug: PF-3512676

Drug: PF-3512676

Drug: PF-3512676

Drug: PF-3512676

Drug: PF-3512676

Drug: PF-3512676

Phase I: 0.28 mg/kg

Experimental group

Description:

Escalating dose groups: 0.28 mg/kg PF-3512676 Injection

Treatment:

Drug: PF-3512676

Drug: PF-3512676

Drug: PF-3512676

Drug: PF-3512676

Drug: PF-3512676

Drug: PF-3512676

Drug: PF-3512676

Drug: PF-3512676

Phase I: 0.32 mg/kg

Experimental group

Description:

Escalating dose groups: 0.32 mg/kg PF-3512676 Injection

Treatment:

Drug: PF-3512676

Drug: PF-3512676

Drug: PF-3512676

Drug: PF-3512676

Drug: PF-3512676

Drug: PF-3512676

Drug: PF-3512676

Drug: PF-3512676

Phase I: 0.36 mg/kg

Experimental group

Description:

Escalating dose groups: 0.36 mg/kg PF-3512676 Injection

Treatment:

Drug: PF-3512676

Drug: PF-3512676

Drug: PF-3512676

Drug: PF-3512676

Drug: PF-3512676

Drug: PF-3512676

Drug: PF-3512676

Drug: PF-3512676

Phase II: 10 mg

Experimental group

Description:

Phase II: 10 mg flat dose (random assignment in Phase II)

Treatment:

Drug: PF-3512676

Drug: PF-3512676

Drug: PF-3512676

Drug: PF-3512676

Drug: PF-3512676

Drug: PF-3512676

Drug: PF-3512676

Drug: PF-3512676

Phase II: 25 mg

Experimental group

Description:

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.

Treatment:

Drug: PF-3512676

Drug: PF-3512676

Drug: PF-3512676

Drug: PF-3512676

Drug: PF-3512676

Drug: PF-3512676

Drug: PF-3512676

Drug: PF-3512676