Concurrent Chemotherapy and Radiation Therapy for Newly Diagnosed Nasal NK Cell Lymphoma

Sponsor
M.D. Anderson Cancer Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT02106988
Collaborator
(none)
40
1
1
96.5
0.4

Study Details

Study Description

Brief Summary

The goal of this clinical research study is to learn if radiation therapy and chemotherapy can help control Stage 1 and/or 2 NK cell lymphoma. The safety of the radiation and chemotherapy combination will also be studied.

This is an investigational study. Radiation and chemotherapy are FDA approved and commercially available for patients with Stage 1 and/or 2 NK cell lymphoma. The combination of these therapies given at the same time is investigational.

Up to 40 patients will take part in this study. All will be enrolled at MD Anderson.

Condition or Disease Intervention/Treatment Phase
Phase 2

Detailed Description

Radiation Therapy:

You will receive radiation therapy 5 days a week for 28 to 30 treatments (up to 6 weeks). You will receive a separate consent form that will describe this treatment and its risks in more detail.

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 Cycle 1 of chemotherapy during your first week of radiation. Each cycle will be 21-days long (or longer if it takes longer for your blood cell counts to recover). You will receive up to 3 cycles of chemotherapy.

On Days 1-3 of each cycle:
  • You will receive dexamethasone by vein over about 15 minutes.

  • You will receive etoposide by vein over 2 hours.

  • You will receive ifosfamide by vein over 3 hours.

  • Mesna is given to protect the bladder from side effects. You will receive mesna by vein as a non-stop infusion over 24 hours on Days 1-3 of each cycle.

  • On Day 1 only, you will receive carboplatin 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. You may also have an EKG, if the doctor thinks it is needed.

On or before Day 1 of Cycle 3:
  • You will have an EKG, if the doctor thinks it is 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. You will no longer be able to receive chemotherapy if the disease gets worse or intolerable side effects occur.

Your participation on the study will be over after the end-of-study and follow-up visits.

Follow-Up Visits:

You will also have routine follow-up visits every 3 months for the 1st year, every 4 month during the 2nd year, and every 6 months during the 3rd-5th years. After that, you will have follow up visits 1 time every year. At these visits, the following tests and procedures will be performed:

  • Blood (about 2 teaspoons) will be drawn for routine tests.

  • Any skin lesions that you may have that are related to the tumor will be measured and photographed.

If your doctor thinks it is needed, your MRI and PET/CT scans will be performed more or less often.

If you leave the study early:
  • You will have CT, MRI, and PET/CT scans to check the status of the disease.

  • Any skin lesions that you may have that are 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Concurrent Chemotherapy and Radiation Therapy for Newly Diagnosed Patients With Stage I/II Nasal NK Cell Lymphoma
Actual Study Start Date :
Jan 16, 2015
Anticipated Primary Completion Date :
Jan 31, 2023
Anticipated Study Completion Date :
Jan 31, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Chemotherapy + Radiation Therapy

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.

Radiation: Radiation Therapy
Radiation therapy delivered for a total dose of 50.4 to 54 Gy 5 days a week for 28 to 30 treatments.
Other Names:
  • XRT
  • Drug: Dexamethasone
    40 mg by vein Days 1-3 in a 21 day cycle.
    Other Names:
  • Decadron
  • Drug: Etoposide phosphate
    67 mg/m2 by vein on Days 1-3 of a 21 day cycle.
    Other Names:
  • VePesid
  • Drug: Ifosfamide
    1 g/m2 by vein on Days 1-3 of a 21 day cycle.
    Other Names:
  • Ifex
  • Drug: Mesna
    0.4 g/m2 by vein on Days 1-3 with Ifosfamide, 0.6 g/m2 by vein over 24 hours daily on Days 1-3 via ambulatory pump.
    Other Names:
  • Mesnex
  • Drug: Carboplatin
    200 mg/m2 by vein on Day 1 of a 21 day cycle.
    Other Names:
  • Paraplatin
  • Outcome Measures

    Primary Outcome Measures

    1. Progression-Free Survival (PFS) [From registration to disease progression or death due to disease, up to 5 years]

      Progression defined as progressive disease or death due to disease. The evaluation of PFS will include all participants who receive radiation, regardless of whether they receive chemotherapy. Progression free survival measured from protocol entry.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    1. Patients with newly diagnosed stage I and II nasal NK cell lymphoma.

    2. Adequate blood cell counts (i.e. ANC > 1000) at baseline, or willingness to accept supportive measures such as transfusions, filgrastim, and Epoetin.

    3. Patients must have adequate liver function as indicated by: *Bilirubin </= 1.5 times the upper limit of normal (ULN), * Alanine transaminase (ALT) </= 2 times the (ULN) or aspartate transaminase (AST) </= 2 times the ULN, *These values must be obtained within two weeks before protocol entry.

    4. Patients are required to have a serum creatinine </= 2.0 mg/dL. This value must be obtained within two weeks before protocol entry.

    5. Left ventricular ejection fraction must be evaluated by nuclear medicine scan or echocardiography and measure >/= 50%.

    6. Male patients must agree to use a barrier method of contraception or agree to abstain from heterosexual activity for the duration of the study.

    7. 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).

    8. Female patients of childbearing potential must have a negative serum pregnancy test (BhCG) within 2 weeks of protocol entry.

    9. Patients must have the ability to give informed consent.

    Exclusion Criteria:
    1. Patients with active Hepatitis B and/or Hepatitis C infection.

    2. Patients with active infections requiring specific anti-infective therapy are not eligible until all signs of infections are resolved.

    3. Patients known to be HIV positive.

    4. 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).

    5. Patients who are pregnant or breast-feeding.

    6. Patients with psychiatric illness and/or social situations that would limit compliance with the study medication and requirements.

    7. 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Texas MD Anderson Cancer Center Houston Texas United States 77030

    Sponsors and Collaborators

    • M.D. Anderson Cancer Center

    Investigators

    • Principal Investigator: Bouthaina Dabaja, MD, M.D. Anderson Cancer Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    M.D. Anderson Cancer Center
    ClinicalTrials.gov Identifier:
    NCT02106988
    Other Study ID Numbers:
    • 2013-0367
    • NCI-2014-01356
    First Posted:
    Apr 8, 2014
    Last Update Posted:
    Jun 28, 2022
    Last Verified:
    Jun 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by M.D. Anderson Cancer Center
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jun 28, 2022