Lymphoma, T-Cell, CutaneousPhase 1/2NCT00043420
CPG 7909 in Patients With Cutaneous T-Cell Lymphoma
A Phase 1/2 study testing PF-3512676 in people with Lymphoma, T-Cell, Cutaneous, run by Pfizer.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoma, T-Cell, Cutaneous
- What is being tested?
- PF-3512676
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- No sites listed yet
- Study dates
- Jan 2003to Mar 2007
- Phase
- Phase 1/2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Patients with visceral involvement, serious infection or illness including human immunodeficiency virus infection, or a Karnofsky Performance Status (KPS) < 60 will be excluded.
About this study
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
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.
- Conditions
- Lymphoma, T-Cell, Cutaneous
- Being tested
- PF-3512676
- Keywords
- immunotherapy, lymphoma
- Medical subject headings
- Lymphoma, T-Cell, Cutaneous, Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PF-3512676Drug
Also called ProMune, CPG 7909
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.
PF-3512676Drug
Also called ProMune, CPG 7909
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.
PF-3512676Drug
Also called ProMune, CPG 7909
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.
PF-3512676Drug
Also called ProMune, CPG 7909
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.
PF-3512676Drug
Also called ProMune, CPG 7909
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.
PF-3512676Drug
Also called ProMune, CPG 7909
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.
PF-3512676Drug
Also called ProMune, CPG 7909
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.
PF-3512676Drug
Also called ProMune, CPG 7909
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.
| Study group | Role | What they receive |
|---|---|---|
| Phase I: 0.08 mg/kg | Experimental | Escalating dose groups: 0.08 mg/kg PF-3512676 Injection Receives: Drug: PF-3512676 |
| Phase I: 0.16 mg/kg | Experimental | Escalating dose groups: 0.16 mg/kg PF-3512676 Injection Receives: Drug: PF-3512676 |
| Phase I: 0.24 mg/kg | Experimental | Escalating dose groups: 0.24 mg/kg PF-3512676 Injection Receives: Drug: PF-3512676 |
| Phase I: 0.28 mg/kg | Experimental | Escalating dose groups: 0.28 mg/kg PF-3512676 Injection Receives: Drug: PF-3512676 |
| Phase I: 0.32 mg/kg | Experimental | Escalating dose groups: 0.32 mg/kg PF-3512676 Injection Receives: Drug: PF-3512676 |
| Phase I: 0.36 mg/kg | Experimental | Escalating dose groups: 0.36 mg/kg PF-3512676 Injection Receives: Drug: PF-3512676 |
| Phase II: 10 mg | Experimental | Phase II: 10 mg flat dose (random assignment in Phase II) Receives: 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. Receives: Drug: PF-3512676 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety: Adverse events, vital signs, clinical and laboratory parameters, physical exams, and ECGs
Measured: 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.
Measured: 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.
Measured: indeterminate
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2002 (estimated)
- Study startJan 2003
- Primary completionMar 2007
- Study completionMar 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Lymphoma, T-Cell, CutaneousStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00043420
- Sponsor's protocol ID
- C014
- Other IDs
- CO14, A8501014
- Status last verified
- Feb 2009
- First submitted
- 8 Aug 2002
- Last updated
- 12 Feb 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 32632956Kim 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.
PubMed 20888065