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VELCADE®,Rituximab,Cyclophosphamide and Decadron (VRCD Regimen)

This study has been completed.
Sponsor:
Collaborator:
Millennium Pharmaceuticals, Inc.
Information provided by (Responsible Party):
Dr. Chadi Nabhan, Oncology Specialists, S.C.
ClinicalTrials.gov Identifier:
NCT00413959
First received: December 19, 2006
Last updated: December 7, 2012
Last verified: December 2012
History of Changes
  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 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Lymphoma
U.S. FDA Resources

Further study details as provided by Oncology Specialists, S.C.:

Primary Outcome Measures:
  • 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. [ Time Frame: 4 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The secondary objectives of this study are to: evaluate this regimen for Overall Survival (OS) [ Time Frame: 4 years ] [ Designated as safety issue: No ]
  • Duration of response and progression-free survival (PFS). [ Time Frame: 4 years ] [ Designated as safety issue: No ]

Enrollment: 12
Study Start Date: August 2006
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Velcade, Rituximab,Cyclophosphamide & Decadron
Velcade 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: VELCADE®
1.6 mg/m^2 of Velcade® given intravenously on days 1, 8, 15 and 22.
Other Name: Bortezomib
Drug: Rituximab
375 mg/m^2 of Rituximab given intravenously on days 1, 8, 15 and 22 during the first cycle then on day 1 of each subsequent cycle.
Other Name: Rituxan
Drug: Cyclophosphamide
400 mg/m^2 of Cyclophosphamide given orally on days 1-4 of each cycle.
Other Name: Cytoxan
Drug: Decadron
40 mg given orally on days 1, 2, 8, 9, 15, 16, 22 and 23
Other Name: dexamethasone

Detailed Description:

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
Criteria

Inclusion Criteria:

  • Small Lymphocytic Lymphoma
  • Follicular Cell Lymphoma (grades I and II)
  • Mantle Cell Lymphoma patients that are not considered eligible for high-dose therapy and stem cell transplant
  • Lymphoplasmacytic lymphoma including Waldenstrom's Macroglobulinemia
  • Marginal Zone Lymphoma
  • MALT Lymphoma that has ONLY failed antibiotic therapy or involved field radiation.
  • Adequate bone marrow function, renal function, and hepatic function as outlined in details below.
  • ECOG performance status of 0, 1, or 2
  • Able to read, understand, and sign an IRB approved informed consent

Exclusion Criteria:

  • Known HIV positive status
  • Known CNS involvement
  • Prior therapy for lymphoma EXCLUDING antibiotic treatment for MALT-Type NHL.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00413959

Locations
United States, Illinois
Onocology Specialists, S.C
Niles, Illinois, United States, 60714
Oncology Specialists, S.C
Park Ridge, Illinois, United States, 60068
Sponsors and Collaborators
Oncology Specialists, S.C.
Millennium Pharmaceuticals, Inc.
Investigators
Principal Investigator: Chadi Nabhan, MD Oncology Specialists, SC
  More Information

No publications provided

Responsible Party: Dr. Chadi Nabhan, Principal Investigator, Oncology Specialists, S.C.
ClinicalTrials.gov Identifier: NCT00413959     History of Changes
Other Study ID Numbers: 0606
Study First Received: December 19, 2006
Last Updated: December 7, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Oncology Specialists, S.C.:
NHL

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Non-Hodgkin
Lymphoma, B-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Cyclophosphamide
Rituximab
Bortezomib
Dexamethasone
Dexamethasone acetate
Dexamethasone 21-phosphate
 BB 1101
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents

ClinicalTrials.gov processed this record on May 19, 2013