Overview

Stage I/II Nasal NK Cell Lymphoma

Status:
Terminated

Trial end date:
2013-05-01

Target enrollment:
0

Participant gender:
All

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 radiation and chemotherapy will also be studied.

Phase:

Phase 1/Phase 2

Accepts Healthy Volunteers?

Details

Lead Sponsor:

M.D. Anderson Cancer Center

Treatments:

Cyclophosphamide
Doxorubicin
Liposomal doxorubicin
Prednisone
Vincristine

Criteria

Inclusion Criteria:

1. Patients with newly diagnosed stage I and II nasal Natural Killer (NK) cell lymphoma.

2. 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.

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

4. Patients are required to have adequate renal function as indicated by a serum
creatinine 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 Myocardial infarction (MI) (within 6 months).

5. Patients with prior exposure to anthracyclines:

6. Patients who are pregnant or breast-feeding.

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

8. 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.