Concurrent Chemotherapy and Radiation Therapy for Newly Diagnosed Nasal NK Cell Lymphoma
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|ClinicalTrials.gov Identifier: NCT02106988|
Recruitment Status : Recruiting
First Posted : April 8, 2014
Last Update Posted : March 20, 2023
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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.
|Condition or disease||Intervention/treatment||Phase|
|Lymphoma||Radiation: Radiation Therapy Drug: Dexamethasone Drug: Etoposide phosphate Drug: Ifosfamide Drug: Mesna Drug: Carboplatin||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Concurrent Chemotherapy and Radiation Therapy for Newly Diagnosed Patients With Stage I/II Nasal NK Cell Lymphoma|
|Actual Study Start Date :||January 16, 2015|
|Estimated Primary Completion Date :||January 31, 2024|
|Estimated Study Completion Date :||January 31, 2024|
Experimental: Chemotherapy + Radiation Therapy
Radiation therapy delivered for a total dose of 50.4 to 54 Gy over 28 to 30 treatments. Within seven days of starting radiotherapy, the first cycle of chemotherapy started and repeated every 3 weeks for a total of 3 cycles.
DeVIC on day 1 of every cycle. Dexamethasone 40 mg by vein Days 1-3, Etoposide 67 mg/m2 by vein on Days 1-3, Ifosfamide 1 g/m2 by vein on Days 1-3, Mesna 0.4 g/m2 by vein on Days 1-3 with Ifosfamide, Mesna 0.6 g/m2 by vein over 24 hours daily on Days 1-3 via ambulatory pump, Carboplatin 200 mg/m2 by vein on Day 1. Cycles repeated every 21 days.
Radiation: Radiation Therapy
Radiation therapy delivered for a total dose of 50.4 to 54 Gy 5 days a week for 28 to 30 treatments.
Other Name: XRT
40 mg by vein Days 1-3 in a 21 day cycle.
Other Name: Decadron
Drug: Etoposide phosphate
67 mg/m2 by vein on Days 1-3 of a 21 day cycle.
Other Name: VePesid
1 g/m2 by vein on Days 1-3 of a 21 day cycle.
Other Name: Ifex
0.4 g/m2 by vein on Days 1-3 with Ifosfamide, 0.6 g/m2 by vein over 24 hours daily on Days 1-3 via ambulatory pump.
Other Name: Mesnex
200 mg/m2 by vein on Day 1 of a 21 day cycle.
Other Name: Paraplatin
- Progression-Free Survival (PFS) [ Time Frame: From registration to disease progression or death due to disease, up to 5 years ]Progression defined as progressive disease or death due to disease. The evaluation of PFS will include all participants who receive radiation, regardless of whether they receive chemotherapy. Progression free survival measured from protocol entry.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Patients with newly diagnosed stage I and II nasal NK cell lymphoma.
- Adequate blood cell counts (i.e. ANC > 1000) at baseline, or willingness to accept supportive measures such as transfusions, filgrastim, and Epoetin.
- 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 a serum creatinine </= 2.0 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.
- 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 MI (within 6 months).
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02106988
|Contact: Bouthaina Dabaja, MDfirstname.lastname@example.org|
|United States, Texas|
|MD Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Contact: Bouthaina Dabaja, MD 713-563-2300 email@example.com|
|Principal Investigator: Bouthaina Dabaja, MD|
|Principal Investigator:||Bouthaina Dabaja, MD||M.D. Anderson Cancer Center|
|Responsible Party:||M.D. Anderson Cancer Center|
|Other Study ID Numbers:||
NCI-2014-01356 ( Registry Identifier: NCI CTRP-Clinical Trials Registry )
|First Posted:||April 8, 2014 Key Record Dates|
|Last Update Posted:||March 20, 2023|
|Last Verified:||March 2023|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
NK cell lymphoma-nasal type
Neoplasms by Histologic Type
Immune System Diseases
Peripheral Nervous System Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents, Phytogenic
Topoisomerase II Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Alkylating