RECRUITING

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

Conditions

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Concurrent Chemotherapy and Radiation Therapy for Newly Diagnosed Patients With Stage I/II Nasal NK Cell Lymphoma

Quick Facts

Study Start:2015-01-16

Study Completion:2034-01-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT02106988

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	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.

Inclusion Criteria

Exclusion 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.

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.

Contacts and Locations

Study Contact

Bouthaina Dabaja, MD

CONTACT

713-563-2300

bdabaja@mdanderson.org

Principal Investigator

Bouthaina Dabaja, MD

PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Study Locations (Sites)

MD Anderson Cancer Center

Houston, Texas, 77030

United States

Collaborators and Investigators

Sponsor: M.D. Anderson Cancer Center

Bouthaina Dabaja, MD, PRINCIPAL_INVESTIGATOR, M.D. Anderson Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2015-01-16

Study Completion Date2034-01-31

Study Record Updates

Study Start Date2015-01-16

Study Completion Date2034-01-31

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

Lymphoma