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Sponsors and Collaborators: |
Yale University Eisai Medical Research Inc. |
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Information provided by: | Yale University |
ClinicalTrials.gov Identifier: | NCT00337987 |
The standard treatment for PTCL is CHOP (cyclophosphamide (C), adriamycin (H), vincristine (O), and prednisone (P)) chemotherapy. This study is attempting to determine whether adding other treatments to CHOP therapy will improve the chance of the disease going into remission or staying in remission. Because other drugs for T-cell lymphoma have not yet been given with CHOP, this study is looking at combining CHOP with ONTAK. ONTAK has been FDA approved for treatment of Cutaneous T cell Lymphoma and works by specifically binding to a protein on the surface of the tumor cells and killing the cell without causing damage to other types of cells in the body. Studies have shown that ONTAK has helped patients with PTCL who have failed chemotherapy.
Condition | Intervention | Phase |
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Peripheral T-Cell Lymphoma |
Drug: Ontak Drug: CHOP (cyclophosphamide (C), adriamycin (H), vincristine (O), and prednisone (P)) chemotherapy |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Pilot Phase II Study to Determine the Safety of the Combination of ONTAK (DAB389IL-2), an Interleukin-2 Fusion Toxin, in Combination With CHOP in Peripheral T-Cell Lymphoma |
Estimated Enrollment: | 50 |
Study Start Date: | November 2005 |
Estimated Study Completion Date: | November 2009 |
Estimated Primary Completion Date: | November 2009 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Noelle Sowers, R.N. | 203-785-2442 | noelle.sowers@yale.edu |
Contact: Donna LaCivita | 203-737-2579 | donna.lacivita@yale.edu |
United States, Connecticut | |
Yale Comprehensive Cancer Center at Yale University School of Medicine | Recruiting |
New Haven, Connecticut, United States, 06520 |
Principal Investigator: | Francine Foss, M.D. | Yale University |
Responsible Party: | Yale University School of Medicine ( Francine Foss, M.D., Principal Investigator ) |
Study ID Numbers: | 0507000369 |
Study First Received: | June 15, 2006 |
Last Updated: | December 2, 2008 |
ClinicalTrials.gov Identifier: | NCT00337987 |
Health Authority: | United States: Institutional Review Board |
Prednisone Immunoproliferative Disorders Vincristine Cyclophosphamide Lymphoma, T-Cell, Peripheral Doxorubicin Lymphatic Diseases |
Interleukin-2 Lymphoma, T-Cell Denileukin diftitox Lymphoproliferative Disorders Lymphoma, Non-Hodgkin Lymphoma Peripheral T-cell lymphoma |
Anti-Inflammatory Agents Neoplasms by Histologic Type Antineoplastic Agents, Hormonal Immune System Diseases Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Mitosis Modulators Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Antimitotic Agents Hormones |
Glucocorticoids Immunosuppressive Agents Pharmacologic Actions Neoplasms Therapeutic Uses Tubulin Modulators Myeloablative Agonists Antineoplastic Agents, Alkylating Antirheumatic Agents Antineoplastic Agents, Phytogenic Alkylating Agents |