Study Stopped
Slow Accrual
Stage I/II Nasal NK Cell Lymphoma
Radiation Therapy Followed by Chemotherapy for Newly Diagnosed Patients With Stage I/II Nasal NK Cell Lymphoma
1 other identifier
interventional
1
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1 lymphoma
Started May 2011
Shorter than P25 for phase_1 lymphoma
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 21, 2011
CompletedFirst Posted
Study publicly available on registry
March 23, 2011
CompletedStudy Start
First participant enrolled
May 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2013
CompletedResults Posted
Study results publicly available
June 23, 2014
CompletedFebruary 5, 2015
May 1, 2014
2 years
March 21, 2011
May 20, 2014
January 21, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression-free Survival (PFS)
Progression-free survival (PFS) defined as time from treatment initiation day to first documented progressive disease or death due to disease. Reviewed with each 21-day treatment cycle, followed every 3-4 months for first 2 years, annually thereafter.
Day 1 to disease progression or death (up to 5+ years)
Study Arms (1)
Radiation + Chemotherapy
EXPERIMENTALRadiation therapy total dose of 50.4 to 54 Gy over 28 to 30 treatments; CHOP Chemotherapy of Cyclophosphamide 750 mg/m2 intravenous piggyback (IVPB), Doxorubicin 50 mg/m2 IVPB, Vincristine 1.4 mg/m2 (max dose 2 mg) IVPB on Day 1, and Oral Prednisone 100 mg daily days 1-5 for four 21-day cycles.
Interventions
50.4 to 54 Gy delivered 5 days a week for 28 to 30 treatments.
750 mg/m2 by vein over 1 hour on Day 1 of a 21 day cycle.
50 mg/m2 by vein over 15 minutes on Day 1 of a 21 day cycle.
1.4 mg/m2 (max dose 2 mg) by vein over 15 minutes on Day 1 of a 21 day cycle.
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
UT MD Anderson Cancer Center
Houston, Texas, 77030, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Early termination with too small number of subjects to perform analysis.
Results Point of Contact
- Title
- Bouthaina Dabaja, MD / Associate Professor, Radiation Oncology
- Organization
- University of Texas MD Anderson Cancer Center
Study Officials
- PRINCIPAL INVESTIGATOR
Bouthaina Dabaja, MD
UT MD Anderson Cancer Center
Publication Agreements
- PI is Sponsor Employee
- Yes
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 21, 2011
First Posted
March 23, 2011
Study Start
May 1, 2011
Primary Completion
May 1, 2013
Study Completion
May 1, 2013
Last Updated
February 5, 2015
Results First Posted
June 23, 2014
Record last verified: 2014-05