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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View this study on Beta.ClinicalTrials.gov

Sponsor:

Information provided by (Responsible Party):

M.D. Anderson Cancer Center

Study Description

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 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

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Detailed Description:

Radiation Therapy:

You will receive radiation therapy 5 days a week for 28 to 30 treatments (up to 6 weeks). You will receive a separate consent form that will describe this treatment and its risks in more detail.

Study Visits During Radiation Therapy:

Every week during radiation therapy:

You will have a physical exam.
Blood (about 1 teaspoon) will be drawn for routine tests.

Chemotherapy Administration:

You will start Cycle 1 of chemotherapy during your first week of radiation. Each cycle will be 21-days long (or longer if it takes longer for your blood cell counts to recover). You will receive up to 3 cycles of chemotherapy.

On Days 1-3 of each cycle:

You will receive dexamethasone by vein over about 15 minutes.
You will receive etoposide by vein over 2 hours.
You will receive ifosfamide by vein over 3 hours.
Mesna is given to protect the bladder from side effects. You will receive mesna by vein as a non-stop infusion over 24 hours on Days 1-3 of each cycle.
On Day 1 only, you will receive carboplatin by vein over 30 minutes.

Study Visits During Chemotherapy:

On or before Day 1, on Day 15 of Cycle 2, and on Day 15 of Cycle 3, blood (about 2 teaspoons) will be drawn for routine tests. You may also have an EKG, if the doctor thinks it is needed.

On or before Day 1 of Cycle 3:

You will have an EKG, if the doctor thinks it is needed.
Blood (about 2 teaspoons) will be drawn for routine tests.

Length of Study:

You may receive radiation and up to 3 cycles of chemotherapy. You will no longer be able to receive chemotherapy if the disease gets worse or intolerable side effects occur.

Your participation on the study will be over after the end-of-study and follow-up visits.

Follow-Up Visits:

You will also have routine follow-up visits every 3 months for the 1st year, every 4 month during the 2nd year, and every 6 months during the 3rd-5th years. After that, you will have follow up visits 1 time every year. At these visits, the following tests and procedures will be performed:

Blood (about 2 teaspoons) will be drawn for routine tests.
Any skin lesions that you may have that are related to the tumor will be measured and photographed.

If your doctor thinks it is needed, your MRI and PET/CT scans will be performed more or less often.

If you leave the study early:

You will have CT, MRI, and PET/CT scans to check the status of the disease.
Any skin lesions that you may have that are related to the tumor will be measured and photographed.
You will have a physical exam.
Blood (about 2 teaspoons) will be drawn for routine tests.

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	40 participants
Allocation:	N/A
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Genetic and Rare Diseases Information Center resources: Lymphosarcoma

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
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 Drug: Dexamethasone 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 Drug: Ifosfamide 1 g/m2 by vein on Days 1-3 of a 21 day cycle. Other Name: Ifex Drug: Mesna 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 Drug: Carboplatin 200 mg/m2 by vein on Day 1 of a 21 day cycle. Other Name: Paraplatin

Arm

Intervention/treatment

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

Drug: Dexamethasone

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

Drug: Ifosfamide

1 g/m2 by vein on Days 1-3 of a 21 day cycle.

Other Name: Ifex

Drug: Mesna

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

Drug: Carboplatin

200 mg/m2 by vein on Day 1 of a 21 day cycle.

Other Name: Paraplatin

Outcome Measures

Primary Outcome Measures :

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.

Eligibility Criteria

Information from the National Library of Medicine

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.

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Contacts and Locations

Information from the National Library of Medicine

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

Contacts

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Contact: Bouthaina Dabaja, MD	713-563-2300	bdabaja@mdanderson.org

Locations

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United States, Texas
MD Anderson Cancer Center	Recruiting
Houston, Texas, United States, 77030
Contact: Bouthaina Dabaja, MD 713-563-2300 bdabaja@mdanderson.org
Principal Investigator: Bouthaina Dabaja, MD

Sponsors and Collaborators

M.D. Anderson Cancer Center

Investigators

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Principal Investigator:	Bouthaina Dabaja, MD	M.D. Anderson Cancer Center

More Information

Additional Information:

MD Anderson Cancer Center This link exits the ClinicalTrials.gov site

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Responsible Party:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT02106988
Other Study ID Numbers:	2013-0367 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

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Studies a U.S. FDA-regulated Drug Product:	Yes
Studies a U.S. FDA-regulated Device Product:	No

Keywords provided by M.D. Anderson Cancer Center:


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

Additional relevant MeSH terms:

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Lymphoma Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Dexamethasone Carboplatin Etoposide Ifosfamide Etoposide phosphate Anti-Inflammatory Agents Antiemetics Autonomic Agents	Peripheral Nervous System Agents Physiological Effects of Drugs Gastrointestinal Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Antineoplastic Agents, Hormonal Antineoplastic Agents Antineoplastic Agents, Phytogenic Topoisomerase II Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents, Alkylating Alkylating Agents

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