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

NCT02106988 | Active Not Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: 2013-0367NCI-2014-01356
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Lymphoma

Keywords

Lymphoma; NK cell lymphoma-nasal type; Radiation therapy; XRT; Dexamethasone; Decadron; Etoposide; VePesid; Ifosfamide; Ifex; Mesna; Mesnex; Carboplatin; Paraplatin

Outcome Measures

Primary Outcomes (1)

• Progression-Free Survival (PFS)

  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.

  From registration to disease progression or death due to disease, up to 5 years

Study Arms (1)

Chemotherapy + Radiation Therapy

EXPERIMENTAL

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; Drug: Dexamethasone; Drug: Etoposide phosphate; Drug: Ifosfamide; Drug: Mesna; Drug: Carboplatin

Interventions

Dexamethasone DRUG

40 mg by vein Days 1-3 in a 21 day cycle.

Also known as: Decadron

Chemotherapy + Radiation Therapy

Ifosfamide DRUG

1 g/m2 by vein on Days 1-3 of a 21 day cycle.

Also known as: Ifex

Chemotherapy + Radiation Therapy

Mesna DRUG

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.

Also known as: Mesnex

Chemotherapy + Radiation Therapy

Carboplatin DRUG

200 mg/m2 by vein on Day 1 of a 21 day cycle.

Also known as: Paraplatin

Chemotherapy + Radiation Therapy

Radiation Therapy RADIATION

Radiation therapy delivered for a total dose of 50.4 to 54 Gy 5 days a week for 28 to 30 treatments.

Also known as: XRT

Chemotherapy + Radiation Therapy

Etoposide phosphate DRUG

67 mg/m2 by vein on Days 1-3 of a 21 day cycle.

Also known as: VePesid

Chemotherapy + Radiation Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with newly diagnosed stage I and II nasal NK cell lymphoma.
• Adequate blood cell counts (i.e. ANC \> 1000) at baseline, or willingness to accept supportive measures such as transfusions, filgrastim, and Epoetin.
• 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.
• Patients are required to have a serum creatinine \</= 2.0 mg/dL. This value must be obtained within two weeks before protocol entry.
• Left ventricular ejection fraction must be evaluated by nuclear medicine scan or echocardiography and measure \>/= 50%.
• Male patients must agree to use a barrier method of contraception or agree to abstain from heterosexual activity for the duration of the study.
• 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).
• Female patients of childbearing potential must have a negative serum pregnancy test (BhCG) within 2 weeks of protocol entry.
• Patients must have the ability to give informed consent.

You may not qualify if:

• Patients with active Hepatitis B and/or Hepatitis C infection.
• Patients with active infections requiring specific anti-infective therapy are not eligible until all signs of infections are resolved.
• Patients known to be HIV positive.
• 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).
• Patients who are pregnant or breast-feeding.
• Patients with psychiatric illness and/or social situations that would limit compliance with the study medication and requirements.
• 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.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• MD Anderson Cancer Center

MeSH Terms

Conditions

Lymphoma

Interventions

Radiotherapy; Dexamethasone; Calcium Dobesilate; etoposide phosphate; Etoposide; Ifosfamide; Mesna; Carboplatin

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Benzenesulfonates; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Glucosides; Glycosides; Carbohydrates; Cyclophosphamide; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phosphoramides; Organophosphorus Compounds; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Alkanesulfonates; Alkanesulfonic Acids; Alkanes; Hydrocarbons, Acyclic; Sulfhydryl Compounds; Coordination Complexes

Study Officials

• Bouthaina Dabaja, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 4, 2014
• First Posted: April 8, 2014
• Study Start: January 16, 2015
• Primary Completion (Estimated): January 31, 2034
• Study Completion (Estimated): January 31, 2034
• Last Updated: April 14, 2026

Record last verified: 2026-04

Locations

US (1)