Study on Chemotherapy and Radiation Therapy for Newly Diagnosed Nasal NK Cell Lymphoma

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT02106988

Provider View

This clinical trial is exploring whether combining radiation therapy with chemotherapy can effectively control Stage 1 and 2 nasal NK cell lymphoma. The study will also assess the safety of using these treatments together.

Patient Parameters

Program Overview

The purpose of this study is to find out if using radiation therapy along with chemotherapy can help manage Stage 1 and 2 nasal NK cell lymphoma. While both treatments are approved for use, their combination in this way is still being researched. Up to 40 patients will participate, all at MD Anderson.

Description

Radiation Therapy:

You will receive radiation therapy 5 days a week for up to 6 weeks, totaling 28 to 30 treatments. A separate consent form will provide more details about this treatment and its risks.

Study Visits During Radiation Therapy:

Every week during radiation therapy:

  • You will have a physical exam.
  • Blood (about 1 teaspoon) will be drawn for routine tests.

Chemotherapy Administration:

You will start your first cycle of chemotherapy during the first week of radiation. Each cycle lasts 21 days or longer if needed for blood cell recovery. You may receive up to 3 cycles.

On Days 1-3 of each cycle:

  • Dexamethasone will be given by vein over about 15 minutes.
  • Etoposide will be given by vein over 2 hours.
  • Ifosfamide will be given by vein over 3 hours.
  • Mesna, to protect the bladder, will be given by vein continuously over 24 hours on Days 1-3.
  • On Day 1 only, carboplatin will be given by vein over 30 minutes.

Study Visits During Chemotherapy:

On or before Day 1, on Day 15 of Cycle 2, and on Day 15 of Cycle 3, blood (about 2 teaspoons) will be drawn for routine tests. An EKG may be done if needed.

On or before Day 1 of Cycle 3:

  • An EKG may be done if needed.
  • Blood (about 2 teaspoons) will be drawn for routine tests.

Length of Study:

You may receive radiation and up to 3 cycles of chemotherapy. Treatment will stop if the disease worsens or if side effects become intolerable. Your participation will end after the final study and follow-up visits.

Follow-Up Visits:

Routine follow-up visits will occur every 3 months for the first year, every 4 months during the second year, and every 6 months during the third to fifth years. After that, visits will be once a year. During these visits:

  • Blood (about 2 teaspoons) will be drawn for routine tests.
  • Any skin lesions related to the tumor will be measured and photographed.

If needed, MRI and PET/CT scans will be done more or less often.

If you leave the study early:

  • CT, MRI, and PET/CT scans will check the disease status.
  • Any skin lesions related to the tumor will be measured and photographed.
  • You will have a physical exam.
  • Blood (about 2 teaspoons) will be drawn for routine tests.

Eligibility Criteria

Inclusion Criteria

  • Newly diagnosed with Stage 1 or 2 nasal NK cell lymphoma.
  • Adequate blood cell counts or willing to accept supportive treatments like transfusions.
  • Adequate liver function based on specific blood test results.
  • Serum creatinine level of 2.0 mg/dL or lower.
  • Heart function with an ejection fraction of 50% or higher.
  • Male patients must use a barrier method of contraception or abstain from heterosexual activity during the study.
  • Female patients must use two barrier methods of contraception or abstain from heterosexual activity, or be postmenopausal.
  • Female patients of childbearing potential must have a negative pregnancy test within 2 weeks before starting the study.
  • Ability to give informed consent.

Exclusion Criteria

  • Active Hepatitis B or C infection.
  • Active infections requiring treatment until resolved.
  • Known HIV positive status.
  • Pre-existing cardiovascular disease requiring ongoing treatment, such as severe heart failure or recent heart attack.
  • Pregnant or breastfeeding women.
  • Psychiatric or social conditions that would limit compliance with the study.
  • Prior radiation to the current disease site if it would exceed safe radiation limits.

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