ClinicalTrials.gov
 Home    Search    Study Topics    Glossary  
 

  Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Combination Chemotherapy in Treating Patients With Burkitt's Lymphoma or Burkitt's Leukemia

This study is ongoing, but not recruiting participants.

Sponsored by: Medical Research Council
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00040690
  Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating patients who have Burkitt's lymphoma or Burkitt's leukemia.


Condition Intervention Phase
Leukemia
Lymphoma
Drug: cyclophosphamide
Drug: cytarabine
Drug: doxorubicin hydrochloride
Drug: etoposide
Drug: filgrastim
Drug: ifosfamide
Drug: leucovorin calcium
Drug: methotrexate
Drug: vincristine sulfate
Procedure: radiation therapy
Phase II

MedlinePlus related topics:   Cancer    Leukemia, Adult Acute    Leukemia, Adult Chronic    Leukemia, Childhood    Lymphoma   

ChemIDplus related topics:   Doxorubicin    Doxorubicin hydrochloride    Ifosfamide    Cyclophosphamide    Filgrastim    Cytarabine    Cytarabine hydrochloride    Etoposide    Leucovorin Calcium    Citrovorum factor    Folinic acid calcium salt pentahydrate    Leucovorin    Methotrexate    Vincristine sulfate    Vincristine    Etoposide phosphate    Calcium gluconate   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Open Label
Official Title:   A Clinicopathological Study In Burkitts's And Burkitt-Like Non-Hodgkin's Lymphoma

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Progression-free survival [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Survival time [ Designated as safety issue: No ]

Estimated Enrollment:   120
Study Start Date:   February 2002

Show detailed description  Show Detailed Description

  Eligibility
Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

DISEASE CHARACTERISTICS:

  • Diagnosis of diffuse B-cell lymphoma in a nodal or an extranodal site

    • CD20 and CD79 positive
    • 100% expression of Ki67 (MIB1) in all of the tumor cells OR
  • Diagnosis of bone marrow replacement/leukemia comprising mature B-cell lymphoma

    • sIg and CD19 positive
    • CD34 and Tdt negative
  • Patients in the low-risk group must meet at least 3 of the following criteria:

    • Normal lactate dehydrogenase (LDH) level
    • WHO performance status 0-1
    • Ann Arbor stage I or II
    • No more than 1 extranodal site (e.g., bone marrow, gastrointestinal tract, or CNS)
  • Patients in the high-risk group must meet at least 2 of the following criteria:

    • Raised LDH level
    • WHO performance status 2-4
    • Ann Arbor stage III or IV
    • More than 1 extranodal site

PATIENT CHARACTERISTICS:

Age:

  • 16 and over

Performance status:

  • See Disease Characteristics

Life expectancy:

  • Not specified

Hematopoietic:

  • See Disease Characteristics

Hepatic:

  • See Disease Characteristics

Renal:

  • Not specified

Other:

  • No mental or physical status that would preclude study
  • No other disease or prior malignancy that would preclude study
  • HIV negative
  • Not pregnant
  • Negative pregnancy test
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • No prior chemotherapy except 1 course of preinduction chemotherapy (e.g., CHOP [cyclophosphamide, doxorubicin, vincristine, and prednisone] or a related regimen)

Endocrine therapy:

  • Not specified

Radiotherapy:

  • No prior radiotherapy

Surgery:

  • Not specified
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00040690

Locations
United Kingdom, England
Medical Research Council Clinical Trials Unit    
      London, England, United Kingdom, NW1 2DA

Sponsors and Collaborators
Medical Research Council

Investigators
Study Chair:     Simon Clawson     Medical Research Council    
  More Information


Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Publications indexed to this study:

Study ID Numbers:   CDR0000069374, MRC-LY10, EU-20117
First Received:   July 8, 2002
Last Updated:   August 23, 2008
ClinicalTrials.gov Identifier:   NCT00040690
Health Authority:   United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
untreated adult acute lymphoblastic leukemia  
L3 adult acute lymphoblastic leukemia  
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

Study placed in the following topic categories:
Leukemia, Lymphoid
Lymphoma, small cleaved-cell, diffuse
Leucovorin
Cyclophosphamide
Etoposide phosphate
Acute lymphoblastic leukemia, adult
Lymphoma, B-Cell
Leukemia
Burkitt's lymphoma
Methotrexate
Epstein-Barr Virus Infections
Etoposide
Lymphoma
Cytarabine
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Immunoproliferative Disorders
Vincristine
Doxorubicin
Herpesviridae Infections
Folic Acid
Virus Diseases
Lymphatic Diseases
Ifosfamide
Burkitt Lymphoma
B-cell lymphomas
DNA Virus Infections
Lymphoproliferative Disorders
Lymphoma, Non-Hodgkin
Isophosphamide mustard

Additional relevant MeSH terms:
Antimetabolites
Anti-Infective Agents
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Tumor Virus Infections
Reproductive Control Agents
Antibiotics, Antineoplastic
Neoplasms, Experimental
Therapeutic Uses
Vitamins
Abortifacient Agents
Micronutrients
Dermatologic Agents
Alkylating Agents
Nucleic Acid Synthesis Inhibitors
Neoplasms by Histologic Type
Vitamin B Complex
Immune System Diseases
Growth Substances
Mitosis Modulators
Enzyme Inhibitors
Antimitotic Agents
Folic Acid Antagonists
Abortifacient Agents, Nonsteroidal
Immunosuppressive Agents
Antiviral Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 10, 2008




Links to all studies - primarily for crawlers