Interferon for Lymphomatoid Granulomatosis
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores the effectiveness of a protein called alpha-interferon in treating lymphomatoid granulomatosis (LYG), a condition where certain cells damage the lungs, skin, kidneys, and central nervous system. Participants will receive either alpha-interferon or a combination of chemotherapy drugs, including EPOCH and Rituximab, based on the severity of their condition. The trial aims to assess the impact of these treatments on LYG and enhance understanding of the disease. Individuals diagnosed with LYG who are interested in new treatment options might be suitable candidates for the trial. As a Phase 2 trial, the research focuses on evaluating the treatment's effectiveness in an initial, smaller group of people.
Do I have to stop taking my current medications for the trial?
The trial information does not specify if you need to stop taking your current medications. It's best to discuss your specific medications with the trial team to get a clear answer.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that interferon alfa-2b effectively treats low-grade lymphomatoid granulomatosis (LYG). In past studies, many patients experienced lasting remission, with significant and prolonged symptom improvement. However, interferon can cause flu-like side effects, such as headaches, fever, chills, and body aches.
EPOCH-R chemotherapy includes several drugs: etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab. These drugs may cause side effects like nausea, hair loss, and weakness. Rituximab can sometimes lead to more serious issues, such as severe skin reactions and hepatitis B reactivation. Patients might also experience bone pain due to G-CSF, a medication that helps bone marrow recover between chemotherapy sessions.
Both treatment options have been studied for safety, but they do have potential side effects that participants should consider. Always consult a healthcare provider to determine the best course of action.12345Why are researchers excited about this trial's treatments?
Researchers are excited about these treatments for lymphomatoid granulomatosis because they offer different approaches from the standard therapies like chemotherapy and monoclonal antibodies alone. Interferon is unique because it boosts the immune system by increasing the body's defense cells, potentially leading to a longer-lasting remission. EPOCH-R combines several chemotherapy drugs with rituximab, a monoclonal antibody, which targets and destroys specific cancer cells, offering a comprehensive attack on the disease. Unlike traditional treatments, these approaches can potentially enhance effectiveness and provide options for patients who don't respond to standard care.
What evidence suggests that this trial's treatments could be effective for lymphomatoid granulomatosis?
Research has shown that interferon alfa-2b effectively treats lymphomatoid granulomatosis (LYG), particularly in its milder form. Studies have found that patients who begin treatment with interferon alfa-2b have a median survival time of 20 years, a significant improvement over the previous survival time of less than two years. Additionally, about 48.5% of these patients do not experience disease progression for at least five years. In this trial, participants in one arm will receive interferon as their treatment.
For more severe cases of LYG, participants in another arm of this trial will receive EPOCH-R, a treatment that includes several drugs like rituximab. Although EPOCH-R is primarily for more serious cases, it has been part of successful treatment plans and can be effective for patients with advanced disease. Overall, both treatments in this trial have shown promising results in managing LYG, offering hope for better survival and disease control.15678Who Is on the Research Team?
Christopher J Melani, M.D.
Principal Investigator
National Cancer Institute (NCI)
Are You a Good Fit for This Trial?
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 for a Trial Participant
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.
What Are the Treatments Tested in This Trial?
Interventions
- EPOCH
- Interferon
- Rituximab
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Cancer Institute (NCI)
Lead Sponsor