Stage I/II Nasal NK Cell Lymphoma
This study has been terminated.
(Slow Accrual)
Sponsor:
M.D. Anderson Cancer Center
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT01321008
First received: March 21, 2011
Last updated: May 10, 2013
Last verified: May 2013
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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:
Drug Information available for:
Cyclophosphamide
Prednisone
Vincristine sulfate
Doxorubicin
Doxorubicin hydrochloride
U.S. FDA Resources
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: Yes ]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 |
| 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), Adriamycin 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:
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.
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| 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. 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 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.
Contacts and Locations
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 |
| Last Updated: | May 10, 2013 |
| 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 May 23, 2013