CpG 7909 in Treating Patients With Cutaneous T-Cell Lymphoma
Recruitment status was Active, not recruiting
RATIONALE: Biological therapies, such as CpG 7909, use different ways to stimulate the immune system and stop cancer cells from growing.
PURPOSE: This randomized phase I/II trial is studying the side effects of CpG 7909 and to see how well it works in treating patients with cutaneous T-cell lymphoma.
|Study Design:||Allocation: Randomized
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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|
- Tumor response rate (complete clinical response [CCR] and partial response [PR]) as measured by the Composite Assessment of Index Lesion Disease Severity [ Designated as safety issue: No ]
- Tumor response as measured by the Physician Global Assessment of Clinical Condition criteria [ Designated as safety issue: No ]
- Duration of overall response (CCR and PR) [ Designated as safety issue: No ]
- Duration of CCR [ Designated as safety issue: No ]
- Duration of PR [ Designated as safety issue: No ]
- Time to response [ Designated as safety issue: No ]
- Time to disease progression [ Designated as safety issue: No ]
|Study Start Date:||July 2004|
- 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 lymphoma.
- 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 drug.
- 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.
|United States, California|
|Jonsson Comprehensive Cancer Center at UCLA|
|Los Angeles, California, United States, 90095-1781|
|Study Chair:||Lauren C. Pinter-Brown, MD||Jonsson Comprehensive Cancer Center|