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Doxorubicin Hydrochloride Liposome and Rituximab With Combination Chemotherapy in Treating Patients With Newly Diagnosed Burkitt's Lymphoma or Burkitt-Like Lymphoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00392990
Recruitment Status : Completed
First Posted : October 26, 2006
Results First Posted : October 15, 2019
Last Update Posted : October 15, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Northwestern University

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 dividing. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Giving rituximab together with combination chemotherapy may kill more cancer cells.

PURPOSE: This phase II trial is studying how well giving doxorubicin hydrochloride liposome and rituximab together with combination chemotherapy works in treating patients with newly diagnosed Burkitt's lymphoma or Burkitt-like lymphoma.


Condition or disease Intervention/treatment Phase
Lymphoma Drug: Regimen A Drug: Regimen B Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter Phase II Study Incorporating DOXIL® and Rituximab Into the Magrath Regimen for HIV-Negative and HIV-Positive Patients With Newly Diagnosed Burkitt's and Burkitt-like Lymphoma
Study Start Date : February 6, 2007
Actual Primary Completion Date : December 3, 2011
Actual Study Completion Date : May 28, 2013


Arm Intervention/treatment
Experimental: Alternating doxil/Magrath regimen & rituximab/Magrath regimen
Patients are stratified between high risk and low risk disease status. Low risk patients receive 3 cycles of rituximab (500 mg/m2) R-CODOX-M chemotherapy IV over 2-4 hours with intrathecal chemotherapy (Regimen A). High risk patients receive 1 cycle of R-CODOX-M chemotherapy IV followed by R-IVAC chemotherapy over 30 minutes(Regimen B); regimens A and B are then repeated.
Drug: Regimen A
Cyclophosphamide (800 mg/m2 IV over 1 hour)+ vincristine (1.5 mg/m2 IV PUSH)+ doxorubicin (40 mg/m2 IV)+ high-dose methotrexate (2,700 mg/m2 IV over 23 hours)+ rituximab (500 mg/m2 IV)(R-CODOX-M) regimen
Other Names:
  • Rituximab
  • Doxil
  • pegylated liposomal doxorubicin
  • cyclophosphamide
  • Cytoxan®
  • CTX
  • CPM
  • Neosar®
  • Vincristine
  • Oncovin®
  • Vincasar PFS®
  • vincristine sulphate
  • VCR
  • leucocristine
  • LCR
  • Methotrexate
  • Methotrexate sodium
  • MTX
  • Mexate
  • Mexate-AQ
  • Folex
  • Folex PFS
  • Abitrexate
  • Rheumatrex
  • Amethopterin

Drug: Regimen B
Rituximab (500 mg/m2 IV once)+ Ifosfamide (1500 mg/m2 IV daily over 3 hours)+ Etoposide (60 mg/m2 IV daily over 1 hour), and Cytarabine (2 grams/m2 IV over 3 hours for 4 doses)
Other Names:
  • Rituximab
  • Ifosfamide
  • Ifex®
  • Etoposide
  • VP-16
  • VePesid®
  • VP-16-213
  • EPEG
  • epipodophyllotoxin
  • NSC # 141540
  • Cytarabine
  • Cytosar-U
  • Ara-C
  • Arabinosyl
  • cytosine arabinoside




Primary Outcome Measures :
  1. Overall Response Rate (ORR) of Patients With Burkitt's and Burkitt-like Lymphoma/Leukemia Treated With Modified Magrath Regimen [ Time Frame: After two cycles of treatment and at completion of treatment (4 cycles for high risk and 3 cycles for low risk) up to approximately 20 weeks. ]

    Response Rate is defined as combined number of patients with Complete Remission (CR) Complete Remission undetermined (Cru) and Partial Remission (PR) for patients with Burkitt's and Burkitt-like Lymphoma/Leukemia. Response will be measured by CT scans following treatment completion and assessed using Response Criteria for Non-Hodgkin's Lymphoma where:

    CR=complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms.

    CRu=same as above but allowing for 75% decrease in lymph node masses and indeterminate or normal bone marrow.

    PR=50% decrease in SPD of the six largest dominant nodes or nodal masses with no increase in size or other nodes, liver, spleen and no new sites of disease.



Secondary Outcome Measures :
  1. Overall Survival (OS) of Patients With Burkitt's and Burkitt-like Lymphoma/Leukemia Treated With Modified Magrath Regimen [ Time Frame: At 2 years from treatment initiation Median follow up 34 months (range 15-45) ]
    Overall Survival (OS) of patients with Burkitt's and Burkitt-like Lymphoma/Leukemia treated with modified Magrath regimen. OS is defined from the first dose of study drug to the time of death for any reason.

  2. Safety of Patients With Burkitt's and Burkitt-like Lymphoma/Leukemia Treated With Modified Magrath Regimen (Addition of Rituximab, Subsitution of Adriamycin for Doxil and Using Lower Dose of Methotrexate) [ Time Frame: After each cycle or monthly (whichever is less frequent), 30 days post last dose. Treatment duration was at a median of 13 weeks (range 11-20) for high-risk patients and 10 weeks (range 9-12) for low-risk patients. ]

    Adverse events (AE) graded as either 3 or 4 and determined to be at least possibly related to study treatment will be collected in patients Burkitt's and Burkitt-like Lymphoma/Leukemia treated with modified Magrath regimen to assess the safety and toxicity profile of the addition of rituximab, subsitution of adriamycin for doxil and lower dose of methotrexate. AEs will be assessed as follows at the following time points: At the end of each cycle or monthly whichever is less frequent and 30 days post last dose of study treatment for a maximum of 3 cycles for regimen A and 4 cycles for regimen B and up to 12 months.

    In general AEs will be assessed according to the National Cancer Institute's Common Toxicity Criteria for adverse events version 3.0 (CTCAE v 3.0). In general adverse events (AEs) will be graded according to the following:

    Grade 1 Mild AE Grade 2 Moderate AE Grade 3 Severe AE Grade 4 Life-threatening or disabling AE Grade 5 Death related to AE


  3. Progression Free Survival (PFS) of Patients With Burkitt's and Burkitt-like Lymphoma/Leukemia Treated With Modified Magrath Regimen [ Time Frame: At 2 years from treatment initiation. Median follow up 34 months (range 15-45) ]
    Progression Free Survival (PFS) will be defined from the first dose of study drug to the first documentation of progressive disease or death for any reason. Patients that are lost to follow-up before progression will be censored at the point of last documentation of not experiencing the event.



Information from the National Library of Medicine

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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

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

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): NCT00392990


Locations
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United States, Illinois
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago, Illinois, United States, 60611-3013
John H. Stroger Cook County Hospital
Chicago, Illinois, United States, 60612
Rush University Medical Center
Chicago, Illinois, United States, 60612
Loyola University Medical Center
Maywood, Illinois, United States, 60153
Advocate Lutheran General Cancer Care Center
Park Ridge, Illinois, United States, 60068-1174
United States, Missouri
Washington University
Saint Louis, Missouri, United States, 63110
United States, New Jersey
The Cancer Institute of New Jersey
New Brunswick, New Jersey, United States, 08901
United States, Ohio
University Hospitals Case Medical Center
Cleveland, Ohio, United States, 44106
Sponsors and Collaborators
Northwestern University
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Leo Gordon, MD Northwestern University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Northwestern University
ClinicalTrials.gov Identifier: NCT00392990    
Other Study ID Numbers: NU 06H2
P30CA060553 ( U.S. NIH Grant/Contract )
NU 06H2 ( Other Identifier: Northwestern University )
NU-1346-018
ORTHO-NU-06H2
CDR0000509706 ( Registry Identifier: PDQ )
STU00004480 ( Other Identifier: Northwestern University IRB )
First Posted: October 26, 2006    Key Record Dates
Results First Posted: October 15, 2019
Last Update Posted: October 15, 2019
Last Verified: August 2019
Keywords provided by Northwestern University:
stage I adult Burkitt lymphoma
stage III adult Burkitt lymphoma
stage IV adult Burkitt lymphoma
contiguous stage II adult Burkitt lymphoma
noncontiguous stage II adult Burkitt lymphoma
AIDS-related peripheral/systemic lymphoma
Additional relevant MeSH terms:
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Burkitt Lymphoma
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Epstein-Barr Virus Infections
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Tumor Virus Infections
Lymphoma, B-Cell
Lymphoma, Non-Hodgkin
Cytarabine
Cyclophosphamide
Ifosfamide
Rituximab
Doxorubicin
Methotrexate
Etoposide
Etoposide phosphate
Vincristine
Liposomal doxorubicin
Podophyllotoxin
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents