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

Launched by M.D. ANDERSON CANCER CENTER · Apr 7, 2014

Keywords

ClinConnect Summary

This clinical trial is looking at how well a combination of chemotherapy and radiation therapy can help control a type of cancer called nasal NK cell lymphoma, specifically in patients who have just been diagnosed with early-stage (Stage 1 or 2) disease. While both treatments are approved and commonly used on their own, this study is investigating the effects of giving them together at the same time. The researchers are also interested in understanding how safe this combination is.

To participate in the study, patients must be newly diagnosed with Stage 1 or 2 nasal NK cell lymphoma and meet certain health criteria, such as having a good level of blood cells and liver function. Up to 40 patients will be enrolled at MD Anderson, and they should expect to receive both treatments during the study. It's important to note that the study is currently recruiting participants, and those interested should talk to their healthcare provider about whether they qualify and what participation would involve.

Gender

ALL

Eligibility criteria

• 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.