CPG 7909 in Patients With Cutaneous T-Cell Lymphoma

February 11, 2009 updated by: Pfizer

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.

Study Overview

Status

Completed

Conditions

Lymphoma, T-Cell, Cutaneous

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

Phase

Phase 2
Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Interventional Model: Single Group Assignment
Masking: None (Open Label)

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: 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 Names: 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 Names: 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 Names: 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 Names: 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 Names: 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 Names: 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 Names: 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 0.08mg/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 Names: 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 Names: 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 Names: 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 Names: 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 Names: 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 Names: 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 Names: 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 Names: 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 0.08mg/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 Names: 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 Names: 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 Names: 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 Names: 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 Names: 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 Names: 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 Names: 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 Names: 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 0.08mg/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 Names: 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 Names: 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 Names: 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 Names: 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 Names: 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 Names: 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 Names: 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 Names: 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 0.08mg/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 Names: 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 Names: 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 Names: 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 Names: 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 Names: 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 Names: 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 Names: 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 Names: 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 0.08mg/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 Names: 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 Names: 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 Names: 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 Names: 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 Names: 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 Names: 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 Names: 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 Names: 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 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 Names: 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 Names: 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 Names: 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 Names: 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 Names: 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 Names: 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 Names: 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 Names: 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 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 Names: 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 Names: 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 Names: 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 Names: 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 Names: 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 Names: 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 Names: 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 Names: ProMune, CPG 7909

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Safety: Adverse events, vital signs, clinical and laboratory parameters, physical exams, and ECGs Time Frame: 24 weeks	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. Time Frame: 24 weeks	24 weeks

Secondary Outcome Measures

Outcome Measure	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. Time Frame: indeterminate	indeterminate

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

To obtain contact information for a study center near you, click here.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2003

Primary Completion (Actual)

March 1, 2007

Study Completion (Actual)

March 1, 2007

Study Registration Dates

First Submitted

August 8, 2002

First Submitted That Met QC Criteria

August 9, 2002

First Posted (Estimate)

August 12, 2002

Study Record Updates

Last Update Posted (Estimate)

February 12, 2009

Last Update Submitted That Met QC Criteria

February 11, 2009

Last Verified

February 1, 2009

More Information

Terms related to this study

Keywords

immunotherapy, lymphoma

Additional Relevant MeSH Terms

Other Study ID Numbers

C014
CO14, A8501014

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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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

Study Overview

Status

Conditions

Intervention / Treatment

Study Type

Enrollment (Actual)

Phase

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Genders Eligible for Study

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Time Frame

Secondary Outcome Measures

Outcome Measure

Time Frame

Collaborators and Investigators

Sponsor

Publications and helpful links

General Publications

Helpful Links

Study record dates

Study Major Dates

Study Start

Primary Completion (Actual)

Study Completion (Actual)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Estimate)

Study Record Updates

Last Update Posted (Estimate)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Clinical Trials on Lymphoma, T-Cell, Cutaneous

Clinical Trials on PF-3512676

Search Similar Trials

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