Status:
UNKNOWN
Combination Chemotherapy and Rituximab in Treating Patients With Primary Mediastinal Diffuse Large B-Cell Lymphoma
Lead Sponsor:
University Hospital Southampton NHS Foundation Trust
Conditions:
Lymphoma
Eligibility:
All Genders
18+ years
Phase:
NA
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...
Detailed Description
OBJECTIVES: Primary * To systematically analyze the phenotype and molecular characteristics in patients with primary mediastinal diffuse large B-cell lymphoma. * To determine the PET response rate f...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
June 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT00689845
Start Date
June 1 2007
Last Update
July 8 2009
Active Locations (8)
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1
Leeds Cancer Centre at St. James's University Hospital
Leeds, England, United Kingdom, LS9 7TF
2
St. George's Hospital
London, England, United Kingdom, SW17 0QT
3
Christie Hospital
Manchester, England, United Kingdom, M20 4BX
4
Mount Vernon Cancer Centre at Mount Vernon Hospital
Northwood, England, United Kingdom, HA6 2RN