Status:
COMPLETED
Treatment and Natural History Study of Lymphomatoid Granulomatosis
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Lymphomatoid Granulomatosis
Granulomatosis, Lymphomatoid
Eligibility:
All Genders
12+ years
Phase:
PHASE2
Brief Summary
This study will evaluate the response and long-term effects of alpha-interferon in patients with lymphomatoid granulomatosis (LYG). The disease causes proliferation of destructive cells involving the ...
Detailed Description
BACKGROUND: * Lymphomatoid granulomatosis (LYG) is an angiocentric destructive proliferation of lymphoid cells predominantly involving the lungs, skin, kidneys, and central nervous system. * It is di...
Eligibility Criteria
- INCLUSION CRITERIA:
Patients must have a tissue-diagnosis of grade 1, 2 and/or 3 lymphomatoid granulomatosis (LYG) (or a diagnosis consistent with LYG) confirmed by the Laboratory of Pathology, National Cancer Institute (NCI). Final histopathologic classification and pathologic grade will be determined by Stephania Pittaluga, medical doctor (M.D.) or her designee.
Patients with any stage of disease will be eligible.
Previously untreated and treated patients are eligible.
Patients aged 12 or older will be eligible.
EXCLUSION CRITERIA:
Patients with a history of coronary artery disease with angina pectoris, or a history of congestive heart failure will not be eligible to receive. etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin and rituximab (DA-EPOCH-R) chemotherapy.
Patients with significant renal (serum creatinine (Cr.) greater than 1.5 mg/dl or creatinine clearance less than 40 cc/min) or hepatic (bilirubin greater than 2.5 x upper limit of normal (ULN) dysfunction not due to tumor involvement will not be eligible to receive DA-EPOCH-R chemotherapy.
Informed consent must be obtained.
Patients who in the opinion of the principal investigator are poor psychiatric or medical risk are not eligible.
Patients who received > 450 mg/m^2 doxorubicin and have a cardiac ejection fraction on echocardiogram less than or equal to 40% on protocol entry are not eligible to received DA-EPOCH-R.
Patients with prior hepatitis B exposure may be included in the study provided that they have hepatitis B virus (HBV) deoxyribonucleic acid (DNA) levels below the World Health Organizations cutoff of 100 IU/mL prior to starting therapy.
Key Trial Info
Start Date :
May 5 1995
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 17 2025
Estimated Enrollment :
94 Patients enrolled
Trial Details
Trial ID
NCT00001379
Start Date
May 5 1995
End Date
January 17 2025
Last Update
June 19 2025
Active Locations (1)
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1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892