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Chemotherapy

Interferon for Lymphomatoid Granulomatosis

Phase 2

Waitlist Available

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

Must not have

Patients who received > 450 mg/m2 doxorubicin and have a cardiac ejection fraction on echocardiogram less than or equal to 40% on protocol entry are not eligible to receive DA-EPOCH-R

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

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

No Placebo-Only Group

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.

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.

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.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have received more than 450 mg/m2 of doxorubicin and my heart's pumping ability is 40% or less.

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I do not have a history of heart disease or heart failure.

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My kidney and liver functions are within normal limits, not affected by cancer.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and post treatment: every 3 months x 1 year, then every 4 months x 1 year, then every 6 months x 1 year then yearly for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Overall response and long-term efficacy

Secondary study objectives

Overall Survival

Side effects data

From 2017 Phase 3 trial • 210 Patients • NCT00577993

96%

Neutropenia

60%

Fatigue

44%

Alopecia

29%

Thrombocytopenia

25%

Fever

23%

Rash / Pruitius

23%

Infection

20%

Anemia

20%

Abdominal Pain

18%

Neuropathy

16%

Nausea / Emisis

11%

Neutropenic Fever

Nausea/Emesis

100%

80%

60%

40%

20%

Study treatment Arm

Rituximab- Fludarabine,Mitoxantrone, and Dexamethasone (FND)

Fludarabine,Mitoxantrone, and Dexamethasone (FND)-Rituximab

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

0 / 3Eligibility criteria met