Status:
WITHDRAWN
Rituximab and Combination Chemotherapy With or Without Bleomycin Sulfate in Treating Patients With Primary Mediastinal Large B-Cell Lymphoma
Lead Sponsor:
Ohio State University Comprehensive Cancer Center
Conditions:
Lymphoma
Eligibility:
All Genders
10+ years
Phase:
PHASE2
Brief Summary
RATIONALE: 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 o...
Detailed Description
OBJECTIVES: Primary * To determine the complete response rate based on PET/CT scan criteria in patients with primary mediastinal large B-cell lymphoma (PMLCL) treated with dose-adjusted rituximab, e...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed primary mediastinal (thymic) large B-cell lymphoma as defined by WHO classification of lymphoid neoplasms
- Diagnosis must be based on an adequate tissue sample, such as an excisional biopsy or core-needle biopsy
- A paraffin-embedded block of well-fixed lymphoma tissue must be available
- Measurable disease, defined as ≥ 1 lesion that can be accurately measured in ≥ 1 dimension as ≥ 10 mm
- No active or untreated CNS lymphoma
- A lumbar puncture is not required in the absence of neurologic symptoms
- PATIENT CHARACTERISTICS:
- ECOG performance status 0-2
- ANC ≥ 1,000/mm\^3 (unless related to disease)
- Platelet count ≥ 100,000/mm\^3 (unless related to disease)
- Total bilirubin ≤ 2.0 times upper limit of normal (ULN)
- AST and/or ALT ≤ 2.5 times ULN
- Creatinine ≤ 2.0 mg/dL
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- Ejection fraction ≥ 45% by MUGA or echocardiogram
- Patients with HIV infection are eligible, provided the following criteria are met:
- No evidence of co-infection with hepatitis B or C
- CD4 cell count ≥ 400/mm\^3
- No evidence of resistant strains of HIV
- HIV viral load ≤ 10,000 copies HIV RNA/mL (if not on anti-HIV therapy)
- HIV viral load ≤ 50 copies HIV RNA/mL (if on anti-HIV therapy)
- No history of AIDS-defining conditions
- No concurrent uncontrolled illness including, but not limited to, the following:
- Ongoing or active infection
- Symptomatic congestive heart failure
- Unstable angina pectoris
- Cardiac arrhythmia
- Psychiatric illness/social situation that would limit compliance with study requirements
- No active secondary malignancy except nonmelanomatous skin cancer
- PRIOR CONCURRENT THERAPY:
- No prior cytotoxic chemotherapy or rituximab
- Prior limited course of glucocorticoids allowed
- No other concurrent investigational or commercial anticancer therapies
Exclusion
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 25 2011
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00983944
Start Date
September 1 2009
End Date
April 25 2011
Last Update
November 30 2017
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