A Phase I/II Open Label, Multi-Center Study For The Evaluation Of CPG 7909 In Patients With Stage IB To IVA Cutaneous T-Cell Lymphoma
- Determine the safety of CpG 7909, in terms of adverse events, vital signs, and
laboratory and clinical findings, in patients with stage IB-IVA cutaneous T-cell
- Determine tumor response, as measured by the Composite Assessment of Index Lesion
Disease Severity (CA), in patients treated with this drug.
- Determine the tolerability of this drug in these patients.
- Determine the immunopharmacodynamics of this drug in these patients.
- Determine disease response, based on the Physician Global Assessment of Clinical
Condition (PGA), in patients treated with this drug.
- Determine duration of response, based on the CA and PGA, in patients treated with this
- Determine time to response in patients treated with this drug.
- Determine time to progression in patients treated with this drug.
OUTLINE: This is a phase I, open-label, multicenter, dose-escalation study followed by a
randomized phase II study.
- Phase I: Patients receive CpG 7909 subcutaneously (SC) once weekly on weeks 1-24 in the
absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of CpG 7909 until the maximum tolerated
dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2
of 6 patients experience dose-limiting toxicity.
- Phase II: Patients are randomized to receive 1 of 2 doses of CpG 7909, administered as
in phase I.
Patients are followed every 4 weeks.
PROJECTED ACCRUAL: A total of 3-56 patients (3-36 for phase I and 20 [10 per treatment arm]
for phase II) will be accrued for this study.
Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment
Tumor response rate (complete clinical response [CCR] and partial response [PR]) as measured by the Composite Assessment of Index Lesion Disease Severity
Lauren C. Pinter-Brown, MD
Jonsson Comprehensive Cancer Center
United States: Federal Government
|Jonsson Comprehensive Cancer Center at UCLA||Los Angeles, California 90095-1781|