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A Pilot Study of Dose Intensification of Methotrexate in Patients With Advanced-Stage (III/IV) Small Non-Cleaved Cell Non-Hodgkins Lymphoma and B-Cell All


Phase 3
N/A
22 Years
Not Enrolling
Both
Leukemia, Lymphoma

Thank you

Trial Information

A Pilot Study of Dose Intensification of Methotrexate in Patients With Advanced-Stage (III/IV) Small Non-Cleaved Cell Non-Hodgkins Lymphoma and B-Cell All


OBJECTIVES:

- 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.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Hazem H. Mahmoud, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Carol G. Simon Cancer Center at Morristown Memorial Hospital

Authority:

United States: Federal Government

Study ID:

CDR0000067965

NCT ID:

NCT00005977

Start Date:

September 2000

Completion Date:

Related Keywords:

  • Leukemia
  • Lymphoma
  • childhood Burkitt lymphoma
  • L3 childhood acute lymphoblastic leukemia
  • B-cell childhood acute lymphoblastic leukemia
  • L3 adult acute lymphoblastic leukemia
  • B-cell adult acute lymphoblastic leukemia
  • stage III adult Burkitt lymphoma
  • stage IV adult Burkitt lymphoma
  • stage III childhood small noncleaved cell lymphoma
  • stage IV childhood small noncleaved cell lymphoma
  • Leukemia
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Lymphoma
  • Lymphoma, Non-Hodgkin

Name

Location

Baylor College of MedicineHouston, Texas  77030
Arizona Cancer CenterTucson, Arizona  85724
Roswell Park Cancer InstituteBuffalo, New York  14263
Walter Reed Army Medical CenterWashington, District of Columbia  20307-5000
Emory University Hospital - AtlantaAtlanta, Georgia  30322
Rush-Presbyterian-St. Luke's Medical CenterChicago, Illinois  60612
University of Massachusetts Memorial Medical CenterWorcester, Massachusetts  01655
University of Mississippi Medical CenterJackson, Mississippi  39216-4505
Washington University School of MedicineSaint Louis, Missouri  63110
University of Rochester Cancer CenterRochester, New York  14642
State University of New York Health Sciences Center - Stony BrookStony Brook, New York  11790-7775
Duke Comprehensive Cancer CenterDurham, North Carolina  27710
Medical University of South CarolinaCharleston, South Carolina  29425-0721
Simmons Cancer Center - DallasDallas, Texas  75235-9154
University of California Davis Medical CenterSacramento, California  95817
Shands Hospital and Clinics, University of FloridaGainesville, Florida  32610-100277
Sylvester Cancer Center, University of MiamiMiami, Florida  33136
CCOP - Florida PediatricTampa, Florida  33682-7757
Tripler Army Medical CenterHonolulu, Hawaii  96859-5000
CCOP - WichitaWichita, Kansas  67214-3882
Children's Hospital of MichiganDetroit, Michigan  48201
Hurley Medical CenterFlint, Michigan  48503
Mount Sinai School of MedicineNew York, New York  10029
Presbyterian HealthcareCharlotte, North Carolina  28233-3549
East Carolina University School of MedicineGreenville, North Carolina  27858-4354
Oklahoma Memorial HospitalOklahoma City, Oklahoma  73126-0307
Medical City Dallas HospitalDallas, Texas  75230
San Antonio Military Pediatric Cancer and Blood Disorders CenterLackland Air Force Base, Texas  78236-5300
University of Texas Health Science Center at San AntonioSan Antonio, Texas  78284-7811
Vermont Cancer CenterBurlington, Vermont  05401-3498
Midwest Children's Cancer CenterMilwaukee, Wisconsin  53226
University of California San Diego Cancer CenterLa Jolla, California  92093-0658
Marlene & Stewart Greenebaum Cancer Center, University of MarylandBaltimore, Maryland  21201
Norris Cotton Cancer CenterLebanon, New Hampshire  03756
State University of New York - Upstate Medical UniversitySyracuse, New York  13210
CCOP - Illinois Oncology Research AssociationPeoria, Illinois  61602
CCOP - Northern New JerseyHackensack, New Jersey  07601
Yale Comprehensive Cancer CenterNew Haven, Connecticut  06520-8028
CCOP - OchsnerNew Orleans, Louisiana  70121
Massachusetts General Hospital Cancer CenterBoston, Massachusetts  02114
University of Alabama at Birmingham Comprehensive Cancer CenterBirmingham, Alabama  35294-3300
Comprehensive Cancer Center at Wake Forest UniversityWinston-Salem, North Carolina  27157-1082
Cancer Center at the University of VirginiaCharlottesville, Virginia  22908
Boston Floating Hospital Infants and ChildrenBoston, Massachusetts  02111
Baptist Hospital of MiamiMiami, Florida  33176-2197
Tulane University School of MedicineNew Orleans, Louisiana  70112
CCOP - Columbia River ProgramPortland, Oregon  97213
University of Texas Medical BranchGalveston, Texas  77555-1329
Naval Medical Center, PortsmouthPortsmouth, Virginia  23708-2197
Massey Cancer CenterRichmond, Virginia  23298-0037
St. Vincent HospitalGreen Bay, Wisconsin  54307-3508
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsBaltimore, Maryland  21231-2410
Dana-Farber Cancer InstituteBoston, Massachusetts  02115
Cancer Research Center of HawaiiHonolulu, Hawaii  96813
MBCCOP - Gulf CoastMobile, Alabama  36688
University of Arkansas for Medical SciencesLittle Rock, Arkansas  72205
University of Kansas Medical CenterKansas City, Kansas  66160-7353
MBCCOP - LSU Health Sciences CenterNew Orleans, Louisiana  70112
Keesler Medical Center - Keesler AFBKeesler AFB, Mississippi  39534-2576
Madigan Army Medical CenterTacoma, Washington  98431-5048
Sutter Cancer CenterSacramento, California  95816
Eastern Maine Medical CenterBangor, Maine  04401
Hackensack University Medical CenterHackensack, New Jersey  07601
University of South Alabama Medical CenterMobile, Alabama  36604
Kaiser Permanente Medical Center - Santa ClaraSanta Clara, California  95051-5386
Broward General Medical CenterFort Lauderdale, Florida  33316
Children's Hospital of Southwest FloridaFort Myers, Florida  33908
Nemours Children's ClinicJacksonville, Florida  32207
Miami Children's HospitalMiami, Florida  33155-4069
Florida Hospital Cancer InstituteOrlando, Florida  32804
All Children's HospitalSt. Petersburg, Florida  33701
St. Mary's HospitalWest Palm Beach, Florida  33407
Saint Jude Midwest AffiliatePeoria, Illinois  61637
Via Christi Regional Medical CenterWichita, Kansas  67214
Maine Children's Cancer ProgramScarborough, Maine  04074-9308
St. John Hospital and Medical CenterDetroit, Michigan  48236
University of Missouri-Columbia Hospital and ClinicsColumbia, Missouri  65212
Cardinal Glennon Children's HospitalSaint Louis, Missouri  63104
Schneider Children's HospitalNew Hyde Park, New York  11042
Carolinas Medical CenterCharlotte, North Carolina  28232-2861
Legacy Emanuel Hospital and Health CenterPortland, Oregon  97227
St. Christopher's Hospital for ChildrenPhiladelphia, Pennsylvania  19134-1095
Children's Hospital of Greenville Hospital SystemGreenville, South Carolina  29605
Driscoll Children's HospitalCorpus Christi, Texas  78466
Cook Children's Medical Center - Fort WorthFort Worth, Texas  76104
Inova Fairfax HospitalFalls Church, Virginia  22042-3300
West Virginia University HospitalsMorgantown, West Virginia  26506-9300
Lucile Packard Children's Hospital at StanfordPalo Alto, California  94304
Hope Children's HospitalOak Lawn, Illinois  60453
Mission Saint Joseph's Health SystemAsheville, North Carolina  28801
Natalie Warren Bryant Cancer CenterTulsa, Oklahoma  74136
Saint Jude Children's Research HospitalMemphis, Tennessee  38105-2794
Children's Hospital and Health CenterSan Diego, California  92123-4282
Children's Memorial Hospital, ChicagoChicago, Illinois  60614
MBCCOP - South Texas PediatricSan Antonio, Texas  78284-7810
Kaiser Permanente-Southern California Permanente Medical GroupSan Diego, California  92120
Scott and White ClinicTemple, Texas  76508
Emory University School of MedicineAtlanta, Georgia  30322
James H. Quillen College of MedicineJohnson City, Tennessee  37614-0622
Carilion Roanoke Community HospitalRoanoke, Virginia  24013
University of Miami-Jackson Memorial Hospital Medical CenterMiami, Florida  33136
University of New Mexico School of MedicineAlbuquerque, New Mexico  87131
West Virginia University Medical School-CharlestonCharleston, West Virginia  25304
Texas Oncology P.A.Dallas, Texas  75230-2503