Stage I/II Nasal NK Cell Lymphoma
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| ClinicalTrials.gov Identifier: NCT01321008 |
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Recruitment Status :
Terminated
(Slow Accrual)
First Posted : March 23, 2011
Results First Posted : June 23, 2014
Last Update Posted : February 5, 2015
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Sponsor:
M.D. Anderson Cancer Center
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Lymphoma | Radiation: Radiation Drug: Cyclophosphamide Drug: Doxorubicin Drug: Vincristine Drug: Prednisone | Phase 1 Phase 2 |
Show detailed description
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 1 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Radiation Therapy Followed by Chemotherapy for Newly Diagnosed Patients With Stage I/II Nasal NK Cell Lymphoma |
| Study Start Date : | May 2011 |
| Actual Primary Completion Date : | May 2013 |
| Actual Study Completion Date : | May 2013 |
| Arm | Intervention/treatment |
|---|---|
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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.
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Radiation: Radiation
50.4 to 54 Gy delivered 5 days a week for 28 to 30 treatments.
Other Names:
Drug: Cyclophosphamide 750 mg/m2 by vein over 1 hour on Day 1 of a 21 day cycle.
Other Names:
Drug: Doxorubicin 50 mg/m2 by vein over 15 minutes on Day 1 of a 21 day cycle.
Other Names:
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. |
Primary Outcome Measures :
- Progression-free Survival (PFS) [ Time Frame: Day 1 to disease progression or death (up to 5+ years) ]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.
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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 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.
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 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.
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): 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 |
Additional Information:
| Responsible Party: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT01321008 |
| Other Study ID Numbers: |
2010-0035 |
| First Posted: | March 23, 2011 Key Record Dates |
| Results First Posted: | June 23, 2014 |
| Last Update Posted: | February 5, 2015 |
| Last Verified: | May 2014 |
Keywords provided by M.D. Anderson Cancer Center:
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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:
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Lymphoma Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Prednisone Cyclophosphamide Doxorubicin Vincristine Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Antirheumatic Agents |
Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Myeloablative Agonists Antibiotics, Antineoplastic Topoisomerase II Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Anti-Inflammatory Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Antineoplastic Agents, Hormonal Antineoplastic Agents, Phytogenic |