Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT00001379 |
| Other study ID # |
940074 |
| Secondary ID |
94-C-0074 |
| Status |
Active, not recruiting |
| Phase |
Phase 2
|
| First received |
|
| Last updated |
|
| Start date |
May 5, 1995 |
| Est. completion date |
February 1, 2034 |
Study information
| Verified date |
June 4, 2024 |
| Source |
National Institutes of Health Clinical Center (CC) |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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 lungs, skin, kidneys, and central nervous system.
Patients ages 12 and older who have LYG and who are not pregnant or breast feeding may be
eligible for this study. Alpha interferon or chemotherapy, or both, will be used. Alpha
interferon is a protein the body naturally produces. If patients have grade 3 disease, they
will usually receive EPOCH-rituximab (EPOCH-R) chemotherapy (each letter representing a
drug). If patients have grade 1 or 2 disease, the will usually receive alpha interferon. If
patients have LYG after receiving alpha interferon and/or EPOCH-R, they may receive rituximab
alone or with alpha interferon. Rituximab is an antibody, binding to a specific molecule
(CD20) present on most B-cell lymphomas. Doses of several drugs in EPOCH-R may be increased
if patients tolerated them in the previous cycle. If patients respond to EPOCH-R but still
have low grade LYG, they may receive alpha interferon. Researchers will also try to obtain a
biopsy of patients lesions, to help in understanding the disease.
Patients self-administer alpha interferon by injection under the skin three times weekly.
They will visit the clinic every 2 to 12 weeks for follow-up. Patients will receive alpha
interferon for 1 year after LYG goes away, depending on response. EPOCH-R has these drugs:
rituximab by vein on Day 1; prednisone by mouth on Days 1 to 5; etoposide, doxorubicin, and
vincristine as a continuous intravenous infusion on Days 1 to 5; and cyclophosphamide by
intravenous injection over 1 hour on Day 5. Each cycle lasts 3 weeks: 5 days of chemotherapy
and 16 days of no chemotherapy. Etoposide, doxorubicin, and vincristine are infused through a
small pump worn by patients. The drugs are given over 5 days through a central intravenous
catheter. There are two cycles of EPOCH-R beyond a maximum response, with six cycles minimum.
To reduce harm to bone marrow, patients receive granulocyte colony stimulating factor
(G-CSF), self-administered by injection under the skin daily for approximately 10 days
between chemotherapy cycles. If at the end of therapy, patients have a complete response,
treatment will stop. If there is residual low grade disease, patients may receive alpha
interferon. Alpha interferon can have flu-like side effects of headache, fever, chills, and
body aches. EPOCH-R drugs can cause gastrointestinal problems, hair loss, and weakness. G-CSF
can cause bone pain, body aches, and hair thinning. Chemotherapy can cause some patients to
develop leukemia.
This study may or may not have a direct benefit for participants. It is not certain whether
the new therapy will help decrease tumors. However, knowledge gained may improve the
understanding of and treatment for LYG.
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 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.
OBJECTIVES:
- To determine the response and long-term efficacy of alpha-Interferon in patients with
lymphomatoid granulomatosis (LYG).
- To determine the response and long-term efficacy of dose-adjusted (DA)-EPOCH-R
chemotherapy in patients with grade 3 LYG or in patients who have failed interferon.
ELIGIBILITY:
- Patients must have a tissue diagnosis of grade 1, 2 and/or 3 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.
DESIGN:
- Interferon is used as initial treatment in patients with grades 1 and 2 LYG . Patients
will receive interferon for one year past CR.
- Patients who progress after or during interferon, and patients with grade 3 LYG will
receive aggressive combination chemotherapy with DA-EPOCH-R (rituximab, etoposide,
doxorubicin, vincristine, cyclophosphamide and prednisone).
- Patients who fail one treatment approach may be crossed over to the other.
- A total of 105 patients will be enrolled at this single institution.
Other known NCT identifiers
