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| Sponsors and Collaborators: |
Oncology Specialists, S.C. Millennium Pharmaceuticals, Inc. |
|---|---|
| Information provided by: | Oncology Specialists, S.C. |
| ClinicalTrials.gov Identifier: | NCT00413959 |
Purpose
Investigate the Overall response rate (OR) and Time to disease progression (TTP) using this regimen in patients with low-grade B-Cell Non-Hodgkin's Lymphoma as classified by the WHO.
| Condition | Intervention | Phase |
|---|---|---|
|
Lymphoma, Non-Hodgkin Lymphoma, B-Cell |
Drug: VELCADE® Drug: Rituximab Drug: Cyclophosphamide Drug: Decadron |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study |
| Official Title: | Phase II Study Investigating the Efficacy of VELCADE®, Rituximab, Cyclophosphamide, and Decadron (VRCD Regimen) in Front-Line Therapy of Patients With Low-Grade Non-Hodgkin's Lymphoma |
| Estimated Enrollment: | 30 |
| Study Start Date: | August 2006 |
| Estimated Study Completion Date: | August 2009 |
| Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
Velcade 1.6 mg/m2 given intravenously on days 1, 8, 15, and 22 Rituximab 375 mg/m2 given intravenously on days 1, 8, 15, and 22 during the first cycle then on day 1 of each subsequent cycle. Dexamethasone 40 mg given orally on days 1, 2, 8, 9, 15, 16, 22, and 23 Cyclophosphamide 400 mg/m2 will be given orally on days 1 through 4 of each cycle.
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Drug: VELCADE®
1.6 mg/m^2 given intravenously on days 1, 8, 15 and 22.
Drug: Rituximab
375 mg/m^2 given intravenously on days 1, 8, 15 and 22 during the first cycle then on day 1 of each subsequent cycle
Drug: Cyclophosphamide
400 mg/m^2 given orally on days 1-4 of each cycle
Drug: Decadron
40 mg given orally on days 1, 2, 8, 9, 15, 16, 22 and 23
|
This is a phase II open label study that is looking at the VRCD combination regimen in patients with previously untreated low-grade Non-Hodgkin's Lymphoma. Treatment will start by combining oral dexamethasone and cyclophosphamide with intravenous VELCADE, rituximab. Chemotherapy cycles will be given as outlined below every 35-days and will continue until two cycles beyond complete remission (CR), toxicity, patient's withdrawal, disease progression, or a maximum of 8 cycles.
Eligibility| Ages Eligible for Study: | 18 Years to 90 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Phillip Gozun | 847-410-0662 | pgozun@oncmed.net |
| Contact: Kathy Tolzien, RN | 847-410-0658 | ktolzien@oncmed.net |
| United States, Illinois | |
| Oncology Specialists, S.C | Recruiting |
| Park Ridge, Illinois, United States, 60068 | |
| Contact: Phillip Gozun 847-410-0662 pgozun@oncmed.net | |
| Contact: Kathy Tolzien, RN 847-410-0658 ktolzien@oncmed.net | |
| Principal Investigator: Chadi Nabhan, MD | |
| Onocology Specialists, S.C | Recruiting |
| Niles, Illinois, United States, 60714 | |
| Contact: Phillip Gozun 847-410-0662 pgozun@oncmed.net | |
| Contact: Kathy Tolzien, RN 847-410-0658 ktolzien@oncmed.net | |
| Principal Investigator: Chadi Nabhan, MD | |
| Principal Investigator: | Chadi Nabhan, MD | Oncology Specialists, SC |
More Information
| Responsible Party: | Oncology Specialists, S.C. ( Chadi Nabhan, MD ) |
| Study ID Numbers: | 0606 |
| Study First Received: | December 19, 2006 |
| Last Updated: | May 21, 2008 |
| ClinicalTrials.gov Identifier: | NCT00413959 |
| Health Authority: | United States: Institutional Review Board |
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NHL |
|
Dexamethasone Immunoproliferative Disorders Rituximab Bortezomib Lymphoma, small cleaved-cell, diffuse Cyclophosphamide Lymphoma, B-Cell |
Lymphatic Diseases B-cell lymphomas Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Lymphoma Dexamethasone acetate |
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Anti-Inflammatory Agents Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Antiemetics Hormones Therapeutic Uses Alkylating Agents Neoplasms by Histologic Type Immune System Diseases Antineoplastic Agents, Hormonal |
Gastrointestinal Agents Enzyme Inhibitors Immunosuppressive Agents Glucocorticoids Pharmacologic Actions Protease Inhibitors Neoplasms Autonomic Agents Myeloablative Agonists Antineoplastic Agents, Alkylating Peripheral Nervous System Agents Antirheumatic Agents Central Nervous System Agents |
