NIH Clinical Research Studies

Protocol Number: 94-C-0074

Active Accrual, Protocols Recruiting New Patients

Title:
Treatment and Natural History Study of Lymphomatoid Granulomatosis
Number:
94-C-0074
Summary:
Lymphomatoid granulomatosis (LYG) is an angiocentric destructive proliferation of lymphoid cells predominantly involving the lungs, skin, kidneys, and central nervous system. It is divided into three grades, depending on the degree of necrosis and cellular atypia. The grades of disease are histologically-based and do not necessarily correlate with clinical outcome. However, like other EBV related LPD's, LYG can transform into an aggressive large B-cell lymphoma, which would be included within the grade 3 category. It is important to note that not all grade 3 lesions are a large B-cell lymphoma. Current evidence shows that LYG is a disease of B cells. Immunohistochemical and PCR analysis of biopsies from 3 patients with LYG demonstrated that EBV was integrated into B-cells but not the T-cells, and as shown in other series, confirms that LYG is an EBV-positive B cell lymphoproliferative disorder. Based on experience with the treatment of four LYG patients with alpha-interferon showing a complete durable remission in 3 patients, we opened this protocol of interferon in LYG. In this protocol, interferon is used as initial treatment in patients with grades 1 and 2 LYG and DA-EPOCH-R is used as initial treatment in patients with grade 3. Patients who fail one treatment approach may be crossed over to the other.
Sponsoring Institute:
National Cancer Institute (NCI)
Recruitment Detail
Type: Active Accrual Of New Subjects
Gender: Male & Female
Referral Letter Required: No
Population Exclusion(s): None

Eligibility Criteria:
INCLUSION CRITERIA:

Patients must have a tissue-diagnosis of grade 1, 2 and/or 3 A/B LYG (or a diagnosis consistent with LYG) confirmed by the Laboratory of Pathology, NCI.

Patients with any stage of disease will be eligible.

Previously untreated and treated patients are eligible.

Patients age 12 or older will be eligible.

Informed consent must be obtained.

EXCLUSION CRITERIA:

Female patients who are pregnant or lactating are not eligible to recieve treatment but can be followed for natural history.

Patients with a history of coronary artery disease with angina pectoris, or a history of congestive heart failure will not be eligible to receive DA-EPOCH-R chemotherapy.

Patients with significant renal (Cr. greater than 1.5 mg/dl or creatinine clearance less than 40 cc/min) or hepatic (bilirubin greater than 2.5 u) dysfunction not due to tumor involvement will not be eligible to receive DA-EPOCH-R chemotherapy.

Patients, who in the opinion of the principal investigator, are poor psychiatric or medical risk are not eligible.

Patients who received greater than 450 mg/m(2) doxorubicin and have a cardiac ejection fraction on MUGA scan less than or equal to 40% on protocol entry are not eligible to receive DA-EPOCH-R.

Special Instructions:
Many protocols are potentially hazardous, are intended only for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this protocol should be consulted before using this protocol. Dose and schedule modifications are required for patients who develop gastrointestinal, hematologic, neurologic, and biochemical (renal, hepatic, etc.) and/or other abnormalities after the administration of therapy. Additionally, Federal regulations for the protection of human subjects require approval of clinical trials by your local Institutional Review Board.
Keywords:
EBV
Lymphoproliferative
Viral
Immunosuppression
Lymphoma
Recruitment Keywords:
None
Conditions:
Lymphomatoid Granulomatosis
Investigational Drug(s):
None
Investigational Device(s):
None

Contacts:
CSSC
Clinical Studies Support Center/NCI
164 Rollins Avenue
2nd FLoor
Rockville, MD 20852
Phone: (888) 624-1937
Fax: (301) 881-8239
Electronic Address: ncicssc@mail.nih.gov

Citations:
Lymphomatoid granulomatosis

Pathologic and clinical spectrum of post-thymic T-cell malignancies

Midline malignant reticulosis

Active Accrual, Protocols Recruiting New Patients

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