Interferon for Lymphomatoid Granulomatosis
Trial Summary
What is the purpose of this trial?
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....
Research Team
Christopher J Melani, M.D.
Principal Investigator
National Cancer Institute (NCI)
Eligibility Criteria
This trial is for individuals aged 12 or older with a confirmed diagnosis of Lymphomatoid Granulomatosis (LYG), regardless of whether they've been treated before. It's not suitable for pregnant or breastfeeding women, those with certain heart conditions, significant kidney or liver dysfunction not caused by the tumor, poor psychiatric or medical risk as assessed by the investigator, prior high-dose doxorubicin recipients with low cardiac function, and patients with active hepatitis B.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive alpha interferon or EPOCH-R chemotherapy based on disease grade. Alpha interferon is administered subcutaneously three times weekly, and EPOCH-R is administered every 3 weeks for up to 6 cycles.
Follow-up
Participants are monitored for safety and effectiveness after treatment. Follow-up includes regular assessments to determine overall response and long-term efficacy.
Treatment Details
Interventions
- EPOCH
- Interferon
- Rituximab
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Who Is Running the Clinical Trial?
National Cancer Institute (NCI)
Lead Sponsor