Status:
COMPLETED
Doxorubicin Hydrochloride Liposome and Rituximab With Combination Chemotherapy in Treating Patients With Newly Diagnosed Burkitt's Lymphoma or Burkitt-Like Lymphoma
Lead Sponsor:
Northwestern University
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as doxorubicin hydrochloride liposome, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from divid...
Detailed Description
OBJECTIVES: Primary * Determine the overall response rate (complete remission, complete remission undetermined, and partial remission) in HIV-negative or HIV-positive patients with newly diagnosed B...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed Burkitt's or Burkitt-like non-Hodgkin's lymphoma meeting 1 of the following risk criteria:
- Low-risk disease meeting all of the following criteria:
- Normal lactate dehydrogenase level
- ECOG performance status 0-1
- Ann Arbor stage I or II
- No tumor mass over 10 cm in greatest diameter
- High-risk disease, defined as disease not meeting low-risk criteria
- Newly diagnosed disease
- PATIENT CHARACTERISTICS:
- ECOG performance status 0-2
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- Hemoglobin ≥ 8.0 g/dL
- Absolute neutrophil count ≥ 500/mm³
- Platelet count ≥ 100,000/mm³ (50,000/mm³ if bone marrow involvement is documented)
- AST and ALT ≤ 3 times upper limit of normal (ULN)
- Alkaline phosphatase ≤ 3 times ULN
- Bilirubin ≤ 1.5 times ULN (3 times ULN if liver metastases are present)
- Creatinine clearance \> 50 mL/min
- Creatinine ≤ 2.0 mg/dL
- LVEF ≥ 45% by MUGA scan or echocardiogram
- No New York Heart Association class II-IV heart failure
- No clinically significant pericardial disease
- No myocardial infarction within the past 6 months
- No uncontrolled angina
- No severe uncontrolled ventricular arrhythmias
- No ECG evidence of acute ischemia or active conduction system abnormalities
- Investigator must document any baseline ECG abnormality as not medically relevant
- No other malignancy within the past year except for basal cell carcinoma of the skin or in situ carcinoma of the cervix
- No other serious medical or psychiatric illness that would preclude study compliance
- PRIOR CONCURRENT THERAPY:
- Prior treatment with 1 course of any combination of rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine, and/or prednisone\* (CHOP)-like therapy allowed, provided the following doses are not exceeded:
- Rituximab 750 mg/m²
- Cyclophosphamide 1,000 mg/m²
- Doxorubicin hydrochloride 50 mg/m²
- Vincristine 2 mg/m²
- No other investigational drugs within the past 14 days
- No other concurrent systemic, cytotoxic, investigational, or chemotherapy agents NOTE: \*No maximum dose restriction on steroids
Exclusion
Key Trial Info
Start Date :
February 6 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 28 2013
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT00392990
Start Date
February 6 2007
End Date
May 28 2013
Last Update
October 15 2019
Active Locations (8)
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1
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago, Illinois, United States, 60611-3013
2
John H. Stroger Cook County Hospital
Chicago, Illinois, United States, 60612
3
Rush University Medical Center
Chicago, Illinois, United States, 60612
4
Loyola University Medical Center
Maywood, Illinois, United States, 60153