CPG 7909 in Patients With Cutaneous T-Cell Lymphoma

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00043420
First received: August 8, 2002
Last updated: February 11, 2009
Last verified: February 2009
  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:


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:
No publications provided by Pfizer

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00043420     History of Changes
Obsolete Identifiers: NCT00091208
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 April 17, 2014