NCT00043420

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jan 2003

Longer than P75 for phase_1

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 8, 2002

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 12, 2002

Completed
5 months until next milestone

Study Start

First participant enrolled

January 1, 2003

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2007

Completed
Last Updated

February 12, 2009

Status Verified

February 1, 2009

Enrollment Period

4.2 years

First QC Date

August 8, 2002

Last Update Submit

February 11, 2009

Conditions

Lymphoma, T-Cell, Cutaneous

Keywords

immunotherapy, lymphoma

Outcome Measures

Primary Outcomes (2)

  • Safety: Adverse events, vital signs, clinical and laboratory parameters, physical exams, and ECGs

    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.

    24 weeks

Secondary Outcomes (1)

  • 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.

    indeterminate

Study Arms (8)

Phase I: 0.08 mg/kg

EXPERIMENTAL

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

Drug: PF-3512676

Phase I: 0.16 mg/kg

EXPERIMENTAL

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

Drug: PF-3512676

Phase I: 0.24 mg/kg

EXPERIMENTAL

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

Drug: PF-3512676

Phase I: 0.28 mg/kg

EXPERIMENTAL

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

Drug: PF-3512676

Phase I: 0.32 mg/kg

EXPERIMENTAL

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

Drug: PF-3512676

Phase I: 0.36 mg/kg

EXPERIMENTAL

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

Drug: PF-3512676

Phase II: 10 mg

EXPERIMENTAL

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

Drug: PF-3512676

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

Interventions

PF-3512676DRUG

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.

Also known as: ProMune, CPG 7909
Phase I: 0.08 mg/kg

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Patients with visceral involvement, serious infection or illness including human immunodeficiency virus infection, or a Karnofsky Performance Status (KPS) \< 60 will be excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Valipour A, Jager M, Wu P, Schmitt J, Bunch C, Weberschock T. Interventions for mycosis fungoides. Cochrane Database Syst Rev. 2020 Jul 7;7(7):CD008946. doi: 10.1002/14651858.CD008946.pub3.

    PMID: 32632956DERIVED

  • Kim YH, Girardi M, Duvic M, Kuzel T, Link BK, Pinter-Brown L, Rook AH. Phase I trial of a Toll-like receptor 9 agonist, PF-3512676 (CPG 7909), in patients with treatment-refractory, cutaneous T-cell lymphoma. J Am Acad Dermatol. 2010 Dec;63(6):975-83. doi: 10.1016/j.jaad.2009.12.052.

    PMID: 20888065DERIVED

Related Links

MeSH Terms

Conditions

Lymphoma, T-Cell, CutaneousLymphoma

Interventions

ProMune

Condition Hierarchy (Ancestors)

Lymphoma, T-CellLymphoma, Non-HodgkinNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 8, 2002

First Posted

August 12, 2002

Study Start

January 1, 2003

Primary Completion

March 1, 2007

Study Completion

March 1, 2007

Last Updated

February 12, 2009

Record last verified: 2009-02