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LymphomaPhase 1/2NCT01321008

Stage I/II Nasal NK Cell Lymphoma

A Phase 1/2 study testing Radiation, Cyclophosphamide and Doxorubicin in people with Lymphoma, run by M.D. Anderson Cancer Center at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lymphoma
What is being tested?
Radiation, Cyclophosphamide and Doxorubicin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1 participants
Where
1 siteUnited States
Study dates
May 2011to May 2013
Phase
Phase 1/2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • UT MD Anderson Cancer Center

    Houston, Texas, 77030

Other trials in United States

About this study

Official title: Radiation Therapy Followed by Chemotherapy for Newly Diagnosed Patients With Stage I/II Nasal NK Cell Lymphoma

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.

Read the detailed description

The Study Treatments:

Radiation therapy is designed to kill cancer cells or to stop cancer cells from growing.

CHOP chemotherapy is made up of the drugs cyclophosphamide, hydroxydaunorubicin (doxorubicin), oncovin (vincristine), and prednisone. It is designed to help control the tumor locally as well as the tumor cells that might have escaped and moved through the body.

Radiation Therapy:

You will receive radiation therapy 5 days a week for 28 to 30 treatments. You will receive a separate consent form that will describe this procedure and its risks in more detail.

Study Visits During Radiation Therapy:

Every week for 6 weeks during radiation therapy:

  • You will be asked how you are feeling and about any side effects you may be having.
  • Your performance status will be recorded.
  • You will have a physical exam.

Chemotherapy Administration:

The amount of time after you finish radiation therapy before you can begin receiving chemotherapy will depend on your recovery time and any side effects you may have. This should be about 3-4 weeks.

On Day 1 you will receive cyclophosphamide by vein over 1 hour, doxorubicin by vein over 15 minutes, and vincristine by vein over 15 minutes. You will take prednisone by mouth on Days 1-5 of each cycle. Each cycle will be 21-days long (or longer if it takes longer for your blood counts to recover). You will receive up to 4 cycles of chemotherapy.

Study Visits During Chemotherapy:

Before Day 1 of Cycle 1:

  • You will have a CT scan of head, neck, chest, abdomen and pelvis.
  • You will have an Magnetic resonance imaging (MRI) scan of the head and neck.
  • You will be asked about any drugs you may be taking and symptoms you may be having.
  • Your performance status will be recorded.
  • You will have a physical exam, including measurement of your height and weight.
  • You will have an echocardiogram (ECHO) and MUltiple Gated Acquisition scan (MUGA) scan.
  • You will have an x-ray of the chest.
  • You will have an Electrocardiography (ECG).
  • Blood (about 2 teaspoons) will be drawn for routine tests.
  • If you are able to become pregnant, you will have a blood (about 2 teaspoons) pregnancy test.

On Day 15 of Cycle 1:

  • You will be asked about any drugs you may be taking and symptoms you may be having.
  • Your performance status will be recorded.
  • Blood (about 2 teaspoons) will be drawn for routine tests.

On Day 1 of Cycles 2-4:

  • You will be asked about any drugs you may be taking and symptoms you may be having.
  • Your performance status will be recorded.
  • You will have an ECG.
  • Blood (about 2 teaspoons) will be drawn for routine tests.

On Day 15 of Cycles 2-4:

-Blood (about 2 teaspoons) will be drawn for routine tests.

Length of Study:

You may receive radiation and up to 4 cycles of CHOP. You will no longer be able to receive CHOP 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 and End-of-Study Visits:

If you leave the study early:

  • You will have a computed tomography (CT) scan of head, neck, chest, abdomen and pelvis.
  • You will have an MRI scan of the head and neck.
  • You will have a positron emission tomography (PET)/CT scan.
  • Any skin lesions that you may have that are related to the tumor will be measured and photographed.
  • You will be asked about any drugs you may be taking and symptoms you may be having.
  • Your performance status will be recorded.
  • You will have a physical exam.
  • Blood (about 2 teaspoons) will be drawn for routine tests.

Routine Follow-up:

  • 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 recorded:
  • You will have a CT scan of head, neck, chest, abdomen and pelvis.
  • You will have an MRI scan of the head and neck.
  • You will have a PET/CT scan.
  • You will be asked about any symptoms you may be having.
  • Blood (about 2 teaspoons) will be drawn for routine tests.

Up to 40 patients will take part in this study. All will be enrolled at University of Texas (UT) MD Anderson Cancer Center.

Conditions
Lymphoma
Keywords
NK cell lymphoma-nasal type, Stage I/II, Radiation therapy, XRT, chemotherapy, CHOP, Cyclophosphamide, Cytoxan, Neosar, Adriamycin, Doxorubicin, Rubex, Vincristine, Oncovin, Prednisone
Medical subject headings
Lymphoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RadiationRadiation

    Also called XRT, Radiation therapy

    50.4 to 54 Gy delivered 5 days a week for 28 to 30 treatments.

  • CyclophosphamideDrug

    Also called Cytoxan, Neosar

    750 mg/m2 by vein over 1 hour on Day 1 of a 21 day cycle.

  • DoxorubicinDrug

    Also called Adriamycin, Rubex

    50 mg/m2 by vein over 15 minutes on Day 1 of a 21 day cycle.

  • VincristineDrug

    Also called Oncovin

    1.4 mg/m2 (max dose 2 mg) by vein over 15 minutes on Day 1 of a 21 day cycle.

  • PrednisoneDrug

    100 mg by mouth daily on Days 1-5 of a 21 day cycle.

Study groups in NCT01321008
Study groupRoleWhat they receive
Radiation + ChemotherapyExperimentalRadiation 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.
Receives: Radiation: Radiation; Drug: Cyclophosphamide; Drug: Doxorubicin; Drug: Vincristine; Drug: Prednisone

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Day 1 to disease progression or death (up to 5+ years)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Mar 2011 (estimated)
  2. Study startMay 2011
  3. Primary completionMay 2013
  4. Study completionMay 2013

Why it stopped: Slow Accrual

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
1 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01321008
Sponsor's protocol ID
2010-0035
Status last verified
May 2014
First submitted
21 Mar 2011
Last updated
5 Feb 2015
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Radiation, Cyclophosphamide and Doxorubicin in people with Lymphoma, run by M.D. Anderson Cancer Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 5 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Jun 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free Survival (PFS) (time frame: Day 1 to disease progression or death (up to 5+ years)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01321008.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2015.

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