Combination Chemotherapy in Treating Patients With Non-Hodgkin's Lymphoma or Acute Lymphocytic Leukemia
NCT ID: NCT00005977
Last Updated: 2013-08-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
83 participants
INTERVENTIONAL
2000-09-30
2006-09-30
Brief Summary
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PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating patients who have non-Hodgkin's lymphoma or acute lymphocytic leukemia.
Detailed Description
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* Determine if increasing the methotrexate dose in combination with standard treatment is feasible in patients with advanced small noncleaved cell non-Hodgkin's lymphoma or B-cell acute lymphocytic leukemia.
* Assess the toxicity of this intensified therapy in these patients.
* Assess the feasibility of treating these patients that have CNS disease at diagnosis with this intensified therapy plus etoposide and ifosfamide.
* Assess toxicities and late effects of this intensive therapy on the central nervous system, cardiac function, and fertility in these patients.
OUTLINE: This is a multicenter study. Patients are stratified according to stage and disease (stage III non-Hodgkin's lymphoma (NHL) vs stage IV NHL with no CNS involvement vs stage IV NHL with CNS involvement vs B-cell acute lymphocytic leukemia (B-ALL) with no CNS involvement vs B-ALL with CNS involvement).
Patients receive methotrexate and cytarabine intrathecally on days 1, 4, 11, and 36 (on day 40 for patients with stage IV NHL or B-ALL only) in combination with alternating courses of: A) cyclophosphamide IV every 12 hours for a total of six doses on days 1-3, doxorubicin IV over 30 minutes on day 4, vincristine IV on days 4 and 11, dexamethasone IV or orally twice daily on days 1-5, and filgrastim (G-CSF) subcutaneously (SQ) or IV over 30 minutes beginning on day 5 and continuing until blood counts recover and B) methotrexate IV over 24 hours on day 18, methotrexate intrathecally on day 18, dexamethasone IV or orally twice daily on days 18-22, leucovorin calcium IV or orally every 6 hours for a total of 6 doses on days 20-21, cytarabine IV over 48 hours on days 20-21, and G-CSF SQ or IV over 30 minutes beginning on day 22 and continuing until blood counts recover. Patients with stage III NHL receive at total of 5 courses of treatment (A-B-A-B-A) and patients with stage IV NHL or B-ALL with no CNS involvement receive a total of 6 courses of treatment (A-B-A-B-A-B).
Patients with CNS involvement receive a third course of treatment: C) etoposide IV over 1 hour on days 36-40, ifosfamide IV over 1 hour on days 36-40, oral dexamethasone twice daily on days 36-40, and G-CSF SQ or IV over 30 minutes beginning on day 41 and continuing until blood counts recover. Patients with CNS involvement receive a total of 7 courses of treatment (A-B-C-A-B-A-B).
Patients are followed every 6 months for 4 years and then annually thereafter.
PROJECTED ACCRUAL: A total of 27-80 patients will be accrued for this study over 24 months.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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STAGE III NHL (Trt 1)
A: Cyclophosphamide (CTX), Doxorubicin hydrochloride, Vincristine sulfate (VCR), Dexamethasone IT Therapy. B: HD-Methotrexate(MTX), Cytarabine(Ara-C), Dexamethasone IT Therapy.
Treatment ABABA
filgrastim
Given IV
cyclophosphamide
Given IV
cytarabine
Given IV
dexamethasone
Given IV
doxorubicin hydrochloride
Given IV
leucovorin calcium
Given IV
methotrexate
Given IV
vincristine sulfate
Given IV
STAGE IV NHL, -CNS (Trt 2)
A: Cyclophosphamide (CTX), Doxorubicin hydrochloride, Vincristine sulfate (VCR), Dexamethasone IT Therapy. B: HD-Methotrexate(MTX), Cytarabine(Ara-C), Dexamethasone IT Therapy.
Treatment ABABAB
filgrastim
Given IV
cyclophosphamide
Given IV
cytarabine
Given IV
dexamethasone
Given IV
doxorubicin hydrochloride
Given IV
leucovorin calcium
Given IV
methotrexate
Given IV
vincristine sulfate
Given IV
STAGE IV, +CNS (Trt 3)
A: Cyclophosphamide (CTX), Doxorubicin hydrochloride, Vincristine sulfate (VCR), Dexamethasone IT Therapy. B: HD-Methotrexate(MTX), Cytarabine(Ara-C), Dexamethasone IT Therapy. C: Etoposide, Ifosfamide, Dexamethasone IT Therapy.
Treatment ABCABAB
filgrastim
Given IV
cyclophosphamide
Given IV
cytarabine
Given IV
dexamethasone
Given IV
doxorubicin hydrochloride
Given IV
etoposide
Given IV
ifosfamide
Given IV
leucovorin calcium
Given IV
methotrexate
Given IV
vincristine sulfate
Given IV
B-ALL, -CNS (Trt 2)
A: Cyclophosphamide (CTX), Doxorubicin hydrochloride, Vincristine sulfate (VCR), Dexamethasone IT Therapy. B: HD-Methotrexate(MTX), Cytarabine(Ara-C), Dexamethasone IT Therapy.
Treatment ABABAB
filgrastim
Given IV
cyclophosphamide
Given IV
cytarabine
Given IV
dexamethasone
Given IV
doxorubicin hydrochloride
Given IV
leucovorin calcium
Given IV
methotrexate
Given IV
vincristine sulfate
Given IV
B-ALL, +CNS (Trt 3)
A: Cyclophosphamide (CTX), Doxorubicin hydrochloride, Vincristine sulfate (VCR), Dexamethasone IT Therapy. B: HD-Methotrexate(MTX), Cytarabine(Ara-C), Dexamethasone IT Therapy. C: Etoposide, Ifosfamide, Dexamethasone IT Therapy.
Treatment ABCABAB
filgrastim
Given IV
cyclophosphamide
Given IV
cytarabine
Given IV
dexamethasone
Given IV
doxorubicin hydrochloride
Given IV
etoposide
Given IV
ifosfamide
Given IV
leucovorin calcium
Given IV
methotrexate
Given IV
vincristine sulfate
Given IV
Interventions
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filgrastim
Given IV
cyclophosphamide
Given IV
cytarabine
Given IV
dexamethasone
Given IV
doxorubicin hydrochloride
Given IV
etoposide
Given IV
ifosfamide
Given IV
leucovorin calcium
Given IV
methotrexate
Given IV
vincristine sulfate
Given IV
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* One of the following diagnoses:
* Histologically confirmed small noncleaved cell non-Hodgkin's lymphoma
* Stage III or IV
* Burkitt's or non-Burkitt's by the Working Formulation OR
* Burkitt's or Burkitt's-like by the REAL classification
* Histologically confirmed B-cell acute lymphocytic leukemia
* At least 25% blasts in bone marrow
* FAB L3 morphology
* FAB L1 morphology allowed if blasts show B-cell markers (CD19, 20, 22) and surface immunoglobulin positivity
* Must be registered on POG-9900 in past 8 days
PATIENT CHARACTERISTICS:
Age:
* Under 22 at time of diagnosis
Performance status:
* Not specified
Life expectancy:
* Not specified
Hematopoietic:
* Not specified
Hepatic:
* Not specified
Renal:
* Not specified
Other:
* Not pregnant or nursing
* Negative pregnancy test
* HIV positive allowed
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* Not specified
Chemotherapy:
* Not specified
Endocrine therapy:
* No concurrent use of dexamethasone as antiemetic
Radiotherapy:
* Not specified
Surgery:
* Prior surgery allowed
Other:
* No prior therapy except surgery
22 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Children's Oncology Group
NETWORK
Responsible Party
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Principal Investigators
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Hazem H. Mahmoud, MD
Role: STUDY_CHAIR
Carol G. Simon Cancer Center at Morristown Memorial Hospital
Locations
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University of Alabama at Birmingham Comprehensive Cancer Center
Birmingham, Alabama, United States
University of South Alabama Medical Center
Mobile, Alabama, United States
MBCCOP - Gulf Coast
Mobile, Alabama, United States
Arizona Cancer Center
Tucson, Arizona, United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
University of California San Diego Cancer Center
La Jolla, California, United States
Lucile Packard Children's Hospital at Stanford
Palo Alto, California, United States
Sutter Cancer Center
Sacramento, California, United States
University of California Davis Medical Center
Sacramento, California, United States
Kaiser Permanente-Southern California Permanente Medical Group
San Diego, California, United States
Children's Hospital and Health Center
San Diego, California, United States
Kaiser Permanente Medical Center - Santa Clara
Santa Clara, California, United States
Yale Comprehensive Cancer Center
New Haven, Connecticut, United States
Walter Reed Army Medical Center
Washington D.C., District of Columbia, United States
Broward General Medical Center
Fort Lauderdale, Florida, United States
Children's Hospital of Southwest Florida
Fort Myers, Florida, United States
Shands Hospital and Clinics, University of Florida
Gainesville, Florida, United States
Nemours Children's Clinic
Jacksonville, Florida, United States
Sylvester Cancer Center, University of Miami
Miami, Florida, United States
University of Miami-Jackson Memorial Hospital Medical Center
Miami, Florida, United States
Miami Children's Hospital
Miami, Florida, United States
Baptist Hospital of Miami
Miami, Florida, United States
Florida Hospital Cancer Institute
Orlando, Florida, United States
All Children's Hospital
St. Petersburg, Florida, United States
CCOP - Florida Pediatric
Tampa, Florida, United States
St. Mary's Hospital
West Palm Beach, Florida, United States
Emory University Hospital - Atlanta
Atlanta, Georgia, United States
Emory University School of Medicine
Atlanta, Georgia, United States
Cancer Research Center of Hawaii
Honolulu, Hawaii, United States
Tripler Army Medical Center
Honolulu, Hawaii, United States
Rush-Presbyterian-St. Luke's Medical Center
Chicago, Illinois, United States
Children's Memorial Hospital, Chicago
Chicago, Illinois, United States
Hope Children's Hospital
Oak Lawn, Illinois, United States
CCOP - Illinois Oncology Research Association
Peoria, Illinois, United States
Saint Jude Midwest Affiliate
Peoria, Illinois, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
CCOP - Wichita
Wichita, Kansas, United States
Via Christi Regional Medical Center
Wichita, Kansas, United States
MBCCOP - LSU Health Sciences Center
New Orleans, Louisiana, United States
Tulane University School of Medicine
New Orleans, Louisiana, United States
CCOP - Ochsner
New Orleans, Louisiana, United States
Eastern Maine Medical Center
Bangor, Maine, United States
Maine Children's Cancer Program
Portland, Maine, United States
Marlene & Stewart Greenebaum Cancer Center, University of Maryland
Baltimore, Maryland, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States
Boston Floating Hospital Infants and Children
Boston, Massachusetts, United States
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
University of Massachusetts Memorial Medical Center
Worcester, Massachusetts, United States
Children's Hospital of Michigan
Detroit, Michigan, United States
St. John Hospital and Medical Center
Detroit, Michigan, United States
Hurley Medical Center
Flint, Michigan, United States
University of Mississippi Medical Center
Jackson, Mississippi, United States
Keesler Medical Center - Keesler AFB
Keesler Air Force Base, Mississippi, United States
University of Missouri-Columbia Hospital and Clinics
Columbia, Missouri, United States
Cardinal Glennon Children's Hospital
St Louis, Missouri, United States
Washington University School of Medicine
St Louis, Missouri, United States
Norris Cotton Cancer Center
Lebanon, New Hampshire, United States
CCOP - Northern New Jersey
Hackensack, New Jersey, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
University of New Mexico School of Medicine
Albuquerque, New Mexico, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
Schneider Children's Hospital
New Hyde Park, New York, United States
Mount Sinai School of Medicine
New York, New York, United States
University of Rochester Cancer Center
Rochester, New York, United States
State University of New York Health Sciences Center - Stony Brook
Stony Brook, New York, United States
State University of New York - Upstate Medical University
Syracuse, New York, United States
Mission Saint Joseph's Health System
Asheville, North Carolina, United States
Carolinas Medical Center
Charlotte, North Carolina, United States
Presbyterian Healthcare
Charlotte, North Carolina, United States
Duke Comprehensive Cancer Center
Durham, North Carolina, United States
East Carolina University School of Medicine
Greenville, North Carolina, United States
Comprehensive Cancer Center at Wake Forest University
Winston-Salem, North Carolina, United States
Oklahoma Memorial Hospital
Oklahoma City, Oklahoma, United States
Natalie Warren Bryant Cancer Center
Tulsa, Oklahoma, United States
CCOP - Columbia River Program
Portland, Oregon, United States
Legacy Emanuel Hospital and Health Center
Portland, Oregon, United States
St. Christopher's Hospital for Children
Philadelphia, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Children's Hospital of Greenville Hospital System
Greenville, South Carolina, United States
James H. Quillen College of Medicine
Johnson City, Tennessee, United States
Saint Jude Children's Research Hospital
Memphis, Tennessee, United States
Driscoll Children's Hospital
Corpus Christi, Texas, United States
Texas Oncology P.A.
Dallas, Texas, United States
Medical City Dallas Hospital
Dallas, Texas, United States
Simmons Cancer Center - Dallas
Dallas, Texas, United States
Cook Children's Medical Center - Fort Worth
Fort Worth, Texas, United States
University of Texas Medical Branch
Galveston, Texas, United States
Baylor College of Medicine
Houston, Texas, United States
San Antonio Military Pediatric Cancer and Blood Disorders Center
Lackland Air Force Base, Texas, United States
MBCCOP - South Texas Pediatric
San Antonio, Texas, United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States
Scott and White Clinic
Temple, Texas, United States
Vermont Cancer Center
Burlington, Vermont, United States
Cancer Center at the University of Virginia
Charlottesville, Virginia, United States
Inova Fairfax Hospital
Falls Church, Virginia, United States
Naval Medical Center, Portsmouth
Portsmouth, Virginia, United States
Massey Cancer Center
Richmond, Virginia, United States
Carilion Roanoke Community Hospital
Roanoke, Virginia, United States
Madigan Army Medical Center
Tacoma, Washington, United States
West Virginia University Medical School-Charleston
Charleston, West Virginia, United States
West Virginia University Hospitals
Morgantown, West Virginia, United States
St. Vincent Hospital
Green Bay, Wisconsin, United States
Midwest Children's Cancer Center
Milwaukee, Wisconsin, United States
Royal Children's Hospital
Parkville, Victoria, Australia
Alberta Children's Hospital
Calgary, Alberta, Canada
Cross Cancer Institute
Edmonton, Alberta, Canada
Children's Hospital
Hamilton, Ontario, Canada
Children's Hospital of Eastern Ontario
Ottawa, Ontario, Canada
Hospital for Sick Children
Toronto, Ontario, Canada
McGill University Health Center - Montreal Children's Hospital
Montreal, Quebec, Canada
Hopital Sainte Justine
Montreal, Quebec, Canada
Laval University Medical Center
Sainte-Foy, Quebec, Canada
Centre Hospitalier de L'Universite Laval
Sainte-Foy, Quebec, Canada
Academisch Ziekenhuis Groningen
Groningen, , Netherlands
San Jorge Childrens Hospital
Santurce, , Puerto Rico
Swiss Pediatric Oncology Group Bern
Bern, , Switzerland
Clinique de Pediatrie
Geneva, , Switzerland
Centre Hospitalier Universitaire Vaudois
Lausanne, , Switzerland
Countries
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Other Identifiers
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COG-9917
Identifier Type: OTHER
Identifier Source: secondary_id
CDR0000067965
Identifier Type: OTHER
Identifier Source: secondary_id
9917
Identifier Type: -
Identifier Source: org_study_id