CPG 7909 in Patients With Cutaneous T-Cell Lymphoma - Full Text View

Purpose

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 1 Phase 2

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lymphoma

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

Safety: Adverse events, vital signs, clinical and laboratory parameters, physical exams, and ECGs [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
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. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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. [ Time Frame: indeterminate ]

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
Experimental: Phase I: 0.08 mg/kg Escalating dose groups: 0.08 mg/kg PF-3512676 Injection	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
Experimental: Phase I: 0.16 mg/kg Escalating dose groups: 0.16 mg/kg PF-3512676 Injection	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
Experimental: Phase I: 0.24 mg/kg Escalating dose groups: 0.24 mg/kg PF-3512676 Injection	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
Experimental: Phase I: 0.28 mg/kg Escalating dose groups: 0.28 mg/kg PF-3512676 Injection	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
Experimental: Phase I: 0.32 mg/kg Escalating dose groups: 0.32 mg/kg PF-3512676 Injection	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
Experimental: Phase I: 0.36 mg/kg Escalating dose groups: 0.36 mg/kg PF-3512676 Injection	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
Experimental: Phase II: 10 mg Phase II: 10 mg flat dose (random assignment in Phase II)	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
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.	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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00043420

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier:	NCT00043420 History of Changes
Other Study ID Numbers:	C014, CO14, A8501014
Study First Received:	August 8, 2002
Last Updated:	February 11, 2009
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pfizer:

immunotherapy, lymphoma

Additional relevant MeSH terms:

Lymphoma
Lymphoma, T-Cell
Lymphoma, T-Cell, Cutaneous
Neoplasms by Histologic Type
Neoplasms

Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin

ClinicalTrials.gov processed this record on May 16, 2013