Stage I/II Nasal NK Cell Lymphoma

This study has been terminated.
(Slow Accrual)
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT01321008
First received: March 21, 2011
Last updated: May 20, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention Phase
Lymphoma
Radiation: Radiation
Drug: Cyclophosphamide
Drug: Doxorubicin
Drug: Vincristine
Drug: Prednisone
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Radiation Therapy Followed by Chemotherapy for Newly Diagnosed Patients With Stage I/II Nasal NK Cell Lymphoma

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Progression-free Survival (PFS) [ Time Frame: Day 1 to disease progression or death (up to 5+ years) ] [ Designated as safety issue: No ]
    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.


Enrollment: 1
Study Start Date: May 2011
Study Completion Date: May 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Radiation + Chemotherapy
Radiation 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.
Radiation: Radiation
50.4 to 54 Gy delivered 5 days a week for 28 to 30 treatments.
Other Names:
  • XRT
  • Radiation therapy
Drug: Cyclophosphamide
750 mg/m2 by vein over 1 hour on Day 1 of a 21 day cycle.
Other Names:
  • Cytoxan
  • Neosar
Drug: Doxorubicin
50 mg/m2 by vein over 15 minutes on Day 1 of a 21 day cycle.
Other Names:
  • Adriamycin
  • Rubex
Drug: Vincristine
1.4 mg/m2 (max dose 2 mg) by vein over 15 minutes on Day 1 of a 21 day cycle.
Other Name: Oncovin
Drug: Prednisone
100 mg by mouth daily on Days 1-5 of a 21 day cycle.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients with newly diagnosed stage I and II nasal Natural Killer (NK) cell lymphoma.
  2. 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.
  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 adequate renal function as indicated by a serum creatinine </= 2.5 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.

Exclusion Criteria:

  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 Myocardial infarction (MI) (within 6 months).
  5. Patients with prior exposure to anthracyclines:
  6. Patients who are pregnant or breast-feeding.
  7. Patients with psychiatric illness and/or social situations that would limit compliance with the study medication and requirements.
  8. 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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01321008

Locations
United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Bouthaina Dabaja, MD UT MD Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01321008     History of Changes
Other Study ID Numbers: 2010-0035
Study First Received: March 21, 2011
Results First Received: May 20, 2014
Last Updated: May 20, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by M.D. Anderson Cancer Center:
NK cell lymphoma-nasal type
Stage I/II
Radiation therapy
XRT
chemotherapy
CHOP
Cyclophosphamide
Cytoxan
Neosar
Adriamycin
Doxorubicin
Rubex
Vincristine
Oncovin
Prednisone

Additional relevant MeSH terms:
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Cyclophosphamide
Doxorubicin
Prednisone
Vincristine
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antibiotics, Antineoplastic
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Anti-Inflammatory Agents
Tubulin Modulators
Antimitotic Agents

ClinicalTrials.gov processed this record on July 26, 2014