Concurrent Chemotherapy and Radiation Therapy for Newly Diagnosed Patients with Stage I/II Nasal NK Cell Lymphoma
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.
Disease Group: Lymphoma
Treatment Agent: Carboplatin,Dexamethasone,Etoposide,Ifosfamide,MESNA,Radiation
Treatment Location: Only at MD Anderson
Primary Objective To measure the progression-free survival in newly diagnosed patients with stage I/II NK cell lymphoma-nasal type when treated with concurrent chemotherapy and radiation, and to evaluate and document the toxicity and efficacy of this approach. Secondary Objective To evaluate the overall survival after successful completion of concurrent chemotherapy with 3 cycles of DeVIC and radiation therapy.
IRB Review and Approval Date: 01/16/2015
Recruitment Status: Open
Projected Accrual: N/A
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.
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.
Information and next steps
For general questions about clinical trials: