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Sponsors and Collaborators: |
Jonsson Comprehensive Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00091208 |
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.
Condition | Intervention | Phase |
---|---|---|
Lymphoma |
Drug: agatolimod sodium |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control |
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 |
Study Start Date: | July 2004 |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a phase I, open-label, multicenter, dose-escalation study followed by a randomized phase II study.
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.
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed cutaneous T-cell lymphoma (CTCL) (limited to mycosis fungoides)
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Immunologic
No autoimmune or antibody-mediated disease, including any of the following:
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
More than 2 weeks since prior systemic antibiotics for CTCL
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 |
Study ID Numbers: | CDR0000384961, UCLA-030104201A, CPGI-C014, CPGI-CPG7909-C014 |
Study First Received: | September 7, 2004 |
Last Updated: | December 6, 2008 |
ClinicalTrials.gov Identifier: | NCT00091208 |
Health Authority: | United States: Federal Government |
recurrent cutaneous T-cell non-Hodgkin lymphoma stage I cutaneous T-cell non-Hodgkin lymphoma stage II cutaneous T-cell non-Hodgkin lymphoma stage III cutaneous T-cell non-Hodgkin lymphoma stage IV cutaneous T-cell non-Hodgkin lymphoma |
recurrent mycosis fungoides/Sezary syndrome stage I mycosis fungoides/Sezary syndrome stage II mycosis fungoides/Sezary syndrome stage III mycosis fungoides/Sezary syndrome stage IV mycosis fungoides/Sezary syndrome |
Sezary syndrome Immunoproliferative Disorders Cutaneous T-cell lymphoma Lymphoma, small cleaved-cell, diffuse Sezary Syndrome Mycosis Fungoides Recurrence |
Mycoses Lymphatic Diseases Lymphoma, T-Cell Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Lymphoma Lymphoma, T-Cell, Cutaneous |
Neoplasms Neoplasms by Histologic Type Immune System Diseases |