Stage I/II Nasal NK Cell Lymphoma

Stopped early · Phase 1/Phase 2

Conditions studied: Lymphoma

In brief

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 radiation and chemotherapy will also be studied.

Key facts

Study ID

NCT01321008

Run by

M.D. Anderson Cancer Center

People needed

1

Starts

2011-05-01

Expected to finish

2013-05-01

Last updated by the study team

2015-02-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients with newly diagnosed stage I and II nasal Natural Killer (NK) cell lymphoma.
• Adequate blood cell counts (i.e. Absolute neutrophil count (ANC)> 1000) at baseline, or willingness to accept supportive measures such as transfusions, filgrastim, and Epoetin. Epoetin will not be administered concurrently with radiation.
• 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 adequate renal function as indicated by a serum creatinine </= 2.5 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 Myocardial infarction (MI) (within 6 months).
• Patients with prior exposure to anthracyclines:
• 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.

Where it is running

• UT MD Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.