MDACC Study Summary 2010-0035 (Archived)

Study Summary
No. 2010-0035:.......Lymphoma......Bouthaina Dabaja......Radiation Oncology

Study Summary Title



Study Summary Number:	2010-0035

Study Title:	Radiation Therapy Followed by Chemotherapy for Newly Diagnosed Patients with Stage I/II Nasal NK Cell Lymphoma

Physician

New Patient Referral



Name:	Bouthaina Dabaja	Patients Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Dept:	Radiation Oncology	Referring MD Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Phone:	713-563-2300 Contact us about clinical trials

General Information



Disease Group:	Lymphoma	Supported By:	N/A

Phase of Study:	Phase I/Phase II	Return Visit:

Treatment Agents:	Adriamycin Cyclophosphamide Prednisone Radiation Vincristine	Home Care:

Treatment Loc:	Only at MDACC

Estimated Length of Stay in Houston:


Description/ Intervention:	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.

Study Objectives / Outcomes

Primary Objective

To evaluate the toxicity and efficacy of radiation therapy, measured as progression-free survival, followed by chemotherapy in newly diagnosed patients with stage I/II NK cell lymphoma-nasal type.

Secondary Objective

To evaluate the overall survival after successful completion of radiation therapy followed by 4 cycles of CHOP (cyclophsphamide, adriamycin, vincristine, and prednisone) chemotherapy.

Study Status Information



Study Activation / Registration Date:

IRB Review and Approval Date:	05/20/2011

Study Type:	Phase Ii Or Phase I/Ii

Recruitment Status:	Terminated

Projected Accrual:	N/A

Enrollment Eligibility

If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

Inclusion Criteria:

1) Patients with newly diagnosed stage I and II nasal NK cell lymphoma.

2) 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.

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 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

Links

Registration Number: NCT01321008
Study Information on Clinical Trials Registry (clinicaltrials.gov)