ClinicalTrials.gov
ClinicalTrials.gov Menu

Combination Chemotherapy and Rituximab in Treating Patients With Primary Mediastinal Diffuse Large B-Cell Lymphoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00689845
Recruitment Status : Unknown
Verified July 2009 by National Cancer Institute (NCI).
Recruitment status was:  Recruiting
First Posted : June 4, 2008
Last Update Posted : July 8, 2009
Sponsor:
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Giving rituximab together with one of five different combination chemotherapy regimens may kill more cancer cells.

PURPOSE: This clinical trial is studying giving rituximab together with combination chemotherapy to see how well it works in treating patients with primary mediastinal diffuse large B-cell lymphoma.


Condition or disease Intervention/treatment Phase
Lymphoma Biological: bleomycin sulfate Biological: filgrastim Biological: rituximab Drug: cyclophosphamide Drug: cytarabine Drug: doxorubicin hydrochloride Drug: etoposide phosphate Drug: ifosfamide Drug: methotrexate Drug: prednisolone Drug: prednisone Drug: vincristine sulfate Drug: vindesine Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Non-Randomized
Primary Purpose: Treatment
Official Title: A Clinico-Pathologic Study of Primary Mediastinal B-Cell Lymphoma (IELSG 26)
Study Start Date : June 2007


Arm Intervention/treatment
Experimental: Cohort 1
Patients receive rituximab IV, cyclophosphamide IV, doxorubicin hydrochloride IV, and vincristine IV on day 1. Patients also receive oral prednisolone on days 1-5. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
Biological: rituximab
given IV

Drug: cyclophosphamide
Given IV

Drug: doxorubicin hydrochloride
Given IV

Drug: prednisolone
Given orally

Drug: vincristine sulfate
Given IV

Experimental: Cohort 2
Patients receive rituximab IV, cyclophosphamide IV, doxorubicin hydrochloride IV, and vincristine IV on day 1, oral prednisolone on days 1-5, and filgrastim (G-CSF) subcutaneously (SC) on days 5-12. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.
Biological: filgrastim
Given subcutaneously

Biological: rituximab
given IV

Drug: cyclophosphamide
Given IV

Drug: doxorubicin hydrochloride
Given IV

Drug: prednisolone
Given orally

Drug: vincristine sulfate
Given IV

Experimental: Cohort 3
Patients receive rituximab IV on days 1, 22, 43, 64, 85, and 106; cyclophosphamide IV and doxorubicin hydrochloride IV on days 1, 15, 29, 43, 57, and 71; methotrexate IV on days 8, 36, and 64; vincristine IV on days 8, 22, 36, 50 ,64, and 78; bleomycin IV on days 22, 50, and 78; and oral prednisolone on days 1-84, followed by a taper.
Biological: bleomycin sulfate
Given IV

Biological: rituximab
given IV

Drug: cyclophosphamide
Given IV

Drug: doxorubicin hydrochloride
Given IV

Drug: methotrexate
Given IV

Drug: prednisolone
Given orally

Drug: vincristine sulfate
Given IV

Experimental: Cohort 4
Patients receive rituximab IV on days 1, 22, 43, 64, 85, and 106; cyclophosphamide IV on days 1, 29, and 57; doxorubicin hydrochloride IV on days 1, 15, 29, 43, 57, and 71; etoposide phosphate IV on days 15, 16, 43, 44, 71, and 72; vincristine IV and bleomycin IV on days 8, 22, 36, 50, 64, and 78; and oral prednisolone on days 1-84, followed by a taper.
Biological: bleomycin sulfate
Given IV

Biological: rituximab
given IV

Drug: cyclophosphamide
Given IV

Drug: doxorubicin hydrochloride
Given IV

Drug: etoposide phosphate
Given IV

Drug: prednisolone
Given orally

Drug: vincristine sulfate
Given IV

Experimental: Cohort 5
Patients receive rituximab IV, doxorubicin hydrochloride IV, and cyclophosphamide IV on day 1; vindesine IV and bleomycin IV on days 1 and 5; oral prednisone on days 1-5; methotrexate intrathecally on day 2; and G-CSF SC on days 6-13 for 4 courses in the absence of disease progression or unacceptable toxicity. After completion of 4 courses of R-ACVBP, patients receive consolidation therapy comprising high-dose methotrexate IV, rituximab IV, ifosfamide IV, etoposide phosphate IV, and cytarabine SC according to protocol GELA LNH03-2B.
Biological: bleomycin sulfate
Given IV

Biological: filgrastim
Given subcutaneously

Biological: rituximab
given IV

Drug: cyclophosphamide
Given IV

Drug: cytarabine
Given subcutaneously

Drug: doxorubicin hydrochloride
Given IV

Drug: etoposide phosphate
Given IV

Drug: ifosfamide
Given IV

Drug: methotrexate
Given IV

Drug: prednisone
Given orally

Drug: vindesine
Given IV




Primary Outcome Measures :
  1. Complete response rate on PET scanning at the completion of chemoimmunotherapy

Secondary Outcome Measures :
  1. Progression-free survival
  2. Death
  3. Survival time


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed primary mediastinal diffuse large B-cell lymphoma

    • CD20-positive disease
    • Any stage of disease
    • Must have a dominant mass within the anterior mediastinum

PATIENT CHARACTERISTICS:

  • ANC ≥ 1.5 x 10^9/L (unless due to lymphoma)
  • Platelets ≥ 100 x 10^9/L (unless due to lymphoma)
  • WBC ≥ 3.0 x 10^9/L (unless due to lymphoma)
  • Serum creatinine ≤ 2 times upper limit of normal (ULN) (unless due to lymphoma)
  • AST/ALT ≤ 2.5 times ULN (unless due to lymphoma)
  • Total bilirubin ≤ 2.5 times ULN (unless due to lymphoma)
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • Must be fit to receive chemotherapy with curative intent
  • No evidence of clinically significant cardiac disease* within the past 12 months, including any of the following:

    • Symptomatic ventricular arrhythmias
    • Congestive heart failure
    • Myocardial infarction NOTE: * Cardiac compromise due to local extension of lymphoma will not be an exclusion criterion in the absence of other cardiac disease.
  • No known HIV infection
  • No psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
  • Able and willing to give informed consent and to undergo staging, including PET scanning

PRIOR CONCURRENT THERAPY:

  • No prior treatment for lymphoma
  • Prior corticosteroids for up to 1 week allowed for the relief of local compressive symptoms

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00689845


Locations
United Kingdom
Leeds Cancer Centre at St. James's University Hospital Recruiting
Leeds, England, United Kingdom, LS9 7TF
Contact: Contact Person    44-113-206-6400      
St. George's Hospital Recruiting
London, England, United Kingdom, SW17 0QT
Contact: Contact Person    44-208-725-2425    rpetteng@sghms.ac.uk   
Christie Hospital Recruiting
Manchester, England, United Kingdom, M20 4BX
Contact: Contact Person    44-845-226-3000      
Mount Vernon Cancer Centre at Mount Vernon Hospital Recruiting
Northwood, England, United Kingdom, HA6 2RN
Contact: Contact Person    44-1923-826-111      
Cancer Research Centre at Weston Park Hospital Recruiting
Sheffield, England, United Kingdom, S1O 2SJ
Contact: Contact Person    44-114-226-5007    b.w.hancock@sheffield.ac.uk   
Southampton General Hospital Recruiting
Southampton, England, United Kingdom, SO16 6YD
Contact: Contact Person    44-238-079-6186    johnsonp@soton.ac.uk   
Royal Marsden - Surrey Recruiting
Sutton, England, United Kingdom, SM2 5PT
Contact: Contact Person    44-208-661-3279    david.cunningham@rmh.nhs.uk   
Saint Bartholomew's Hospital Recruiting
London, United Kingdom
Contact: Contact Person    44-207-796-3979    silvia.montoto@cancer.org.uk   
Sponsors and Collaborators
University Hospital Southampton NHS Foundation Trust
Investigators
Principal Investigator: Peter Johnson, MD University Hospital Southampton NHS Foundation Trust

ClinicalTrials.gov Identifier: NCT00689845     History of Changes
Other Study ID Numbers: CDR0000588011
USCTU-IELSG-26-RHM-CAN0546
EU-20818
EudraCT 2006-005794-22
USCTU-07/Q1704/68
First Posted: June 4, 2008    Key Record Dates
Last Update Posted: July 8, 2009
Last Verified: July 2009

Keywords provided by National Cancer Institute (NCI):
contiguous stage II adult diffuse large cell lymphoma
noncontiguous stage II adult diffuse large cell lymphoma
stage I adult diffuse large cell lymphoma
stage III adult diffuse large cell lymphoma
stage IV adult diffuse large cell lymphoma

Additional relevant MeSH terms:
Lymphoma
Lymphoma, B-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Cyclophosphamide
Methotrexate
Cytarabine
Rituximab
Ifosfamide
Isophosphamide mustard
Liposomal doxorubicin
Etoposide phosphate
Doxorubicin
Prednisone
Etoposide
Vincristine
Prednisolone
Methylprednisolone Hemisuccinate
Bleomycin
Vindesine
Lenograstim
Prednisolone acetate
Methylprednisolone acetate
Methylprednisolone
Prednisolone hemisuccinate