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Alkylating agents

Chemo + Radiation for Nasal NK Cell Lymphoma

Phase 2

Recruiting

Led By Bouthaina Dabaja, MD

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients with newly diagnosed stage I and II nasal NK cell lymphoma

Female patients must be willing to use two adequate barrier methods of contraception to prevent pregnancy or agree to abstain from heterosexual activity throughout the study or be post menopausal (free from menses > two years or surgically sterilized)

Must not have

Patients with pre-existing cardiovascular disease requiring ongoing treatment. This includes: a) Congestive heart failure class III/IV CHF per new york heart association (NYHA) criteria, b) Cardiomyopathy, c) Uncontrolled cardiac arrhythmia, d) Unstable angina pectoris, e) Recent MI (within 6 months)

Prior radiation to the site of current primary disease, if re-treatment would lead to violation of known radiation dose tolerance limits for that site

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from registration to disease progression or death due to disease, up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is studying if radiation therapy and chemotherapy can help control Stage 1 and/or 2 NK cell lymphoma and the safety of the radiation and chemotherapy combination.

Who is the study for?

This trial is for adults with newly diagnosed stage I or II nasal NK cell lymphoma. Participants need normal blood counts, kidney and liver function, heart efficiency (ejection fraction ≥50%), and must not be pregnant or breastfeeding. They should agree to use contraception if of childbearing potential and have no active infections like Hepatitis B/C, HIV, severe heart conditions, or psychiatric issues that affect compliance.

What is being tested?

The study tests the effectiveness of combining radiation therapy with chemotherapy drugs Etoposide phosphate, Ifosfamide, Carboplatin, Dexamethasone, and Mesna in controlling early-stage nasal NK cell lymphoma. The safety of this concurrent treatment approach is also being evaluated.

What are the potential side effects?

Potential side effects include those common to chemotherapy such as nausea, fatigue, hair loss; radiation may cause skin irritation at the site of treatment. There's a risk of lowered blood counts leading to infection or bleeding complications.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with early-stage nasal NK cell lymphoma.

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I am using two forms of birth control or am not having sex to avoid pregnancy, or I cannot get pregnant due to menopause or surgery.

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My liver is functioning well, based on recent tests.

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I agree to use contraception or abstain from sex during the study.

Exclusion Criteria

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

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I have a serious heart condition that needs ongoing treatment.

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I've had radiation before where my cancer is now, and can't have more without risking harm.

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I have an active Hepatitis B or C infection.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from registration to disease progression or death due to disease, up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from registration to disease progression or death due to disease, up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and from registration to disease progression or death due to disease, up to 5 years for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Progression-Free Survival (PFS)

Awards & Highlights

No Placebo-Only Group

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: Chemotherapy + Radiation TherapyExperimental Treatment6 Interventions

Radiation therapy delivered for a total dose of 50.4 to 54 Gy over 28 to 30 treatments. Within seven days of starting radiotherapy, the first cycle of chemotherapy started and repeated every 3 weeks for a total of 3 cycles. DeVIC on day 1 of every cycle. Dexamethasone 40 mg by vein Days 1-3, Etoposide 67 mg/m2 by vein on Days 1-3, Ifosfamide 1 g/m2 by vein on Days 1-3, Mesna 0.4 g/m2 by vein on Days 1-3 with Ifosfamide, Mesna 0.6 g/m2 by vein over 24 hours daily on Days 1-3 via ambulatory pump, Carboplatin 200 mg/m2 by vein on Day 1. Cycles repeated every 21 days.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ifosfamide

2010

Completed Phase 4

~3350

Carboplatin

2014

Completed Phase 3

~6120