Your session is about to expire
← Back to Search
Chemotherapy
Interferon for Lymphomatoid Granulomatosis
Phase 2
Recruiting
Led By Christopher J Melani, M.D.
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up post treatment: every 3 months x 1 year, then every 4 months x 1 year, then every 6 months x 1 year then yearly
Awards & highlights
Study Summary
This trial is studying alpha interferon to see how well it works in treating patients with lymphomatoid granulomatosis.
Who is the study for?
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.Check my eligibility
What is being tested?
The study tests alpha-interferon and EPOCH-R chemotherapy in treating LYG. Alpha-interferon is a natural protein given through skin injections thrice weekly. EPOCH-R involves multiple drugs administered intravenously over five days every three weeks. The treatment plan varies based on disease grade and patient response to previous cycles.See study design
What are the potential side effects?
Alpha-interferon can cause flu-like symptoms such as headaches, fever, chills, and body aches. EPOCH-R may lead to gastrointestinal issues, hair loss, weakness; G-CSF injections used between chemotherapy cycles can result in bone pain and hair thinning. There's also a risk that chemotherapy could lead to leukemia.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ post treatment: every 3 months x 1 year, then every 4 months x 1 year, then every 6 months x 1 year then yearly
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~post treatment: every 3 months x 1 year, then every 4 months x 1 year, then every 6 months x 1 year then yearly
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall response and long-term efficacy
Secondary outcome measures
Overall Survival
Side effects data
From 2017 Phase 3 trial • 210 Patients • NCT0057799396%
Neutropenia
60%
Fatigue
44%
Alopecia
29%
Thrombocytopenia
25%
Fever
23%
Infection
23%
Rash / Pruitius
20%
Anemia
20%
Abdominal Pain
18%
Neuropathy
16%
Nausea / Emisis
11%
Neutropenic Fever
5%
Nausea/Emesis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Rituximab- Fludarabine,Mitoxantrone, and Dexamethasone (FND)
Fludarabine,Mitoxantrone, and Dexamethasone (FND)-Rituximab
Trial Design
2Treatment groups
Experimental Treatment
Group I: 2Experimental Treatment1 Intervention
EPOCH-R every 3 weeks for up to 6 cycles, based on response.
Group II: 1Experimental Treatment1 Intervention
Interferon starting at 7.5 million Units subQ 3 times a week and increasing on the designated schedule, as tolerated. Patients continue taking interferon for 1 year beyond CR. Patients who progress may crossover to receive EPOCH-R.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Interferon
1998
Completed Phase 3
~690
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,666 Previous Clinical Trials
40,925,900 Total Patients Enrolled
74 Trials studying Lymphomatoid Granulomatosis
3,834 Patients Enrolled for Lymphomatoid Granulomatosis
Christopher J Melani, M.D.Principal InvestigatorNational Cancer Institute (NCI)
5 Previous Clinical Trials
396 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have received more than 450 mg/m2 of doxorubicin and my heart's pumping ability is 40% or less.My cancer is at any stage.I am 12 years old or older.I have or have not received treatment for my condition before.I do not have a history of heart disease or heart failure.My kidney and liver functions are within normal limits, not affected by cancer.I have had hepatitis B but my virus levels are low enough to start treatment.
Research Study Groups:
This trial has the following groups:- Group 1: 1
- Group 2: 2
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What purpose does Interferon usually serve?
"Interferon is a medication that, while typically used to treat dlbcl, can also be effective for other b-cell lymphomas, polyangium, and pemphigus vulgaris."
Answered by AI
Could you please tell me the risks associated with Interferon?
"Although Phase 2 trials have yet to produce data supporting efficacy, Interferon has been deemed safe by our team and given a score of 2."
Answered by AI
Are there any current vacancies in this research project for new participants?
"This study is actively recruiting patients, according to the information posted on clinicaltrials.gov. The study was first posted on May 5, 1995 and was last updated on November 4, 2022."
Answered by AI
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger