Combination Chemotherapy in Treating Patients With Non-Hodgkin's Lymphoma or Acute Lymphocytic Leukemia

August 19, 2013 updated by: Children's Oncology Group

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

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 cancer cells.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating patients who have non-Hodgkin's lymphoma or acute lymphocytic leukemia.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

83

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Victoria
      • Parkville, Victoria, Australia, 3052
        • Royal Children's Hospital
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2T 5C7
        • Alberta Children's Hospital
      • Edmonton, Alberta, Canada, T6G 1Z2
        • Cross Cancer Institute
    • Ontario
      • Hamilton, Ontario, Canada, L8N 3Z5
        • Children's Hospital
      • Ottawa, Ontario, Canada, K1H 8L1
        • Children's Hospital of Eastern Ontario
      • Toronto, Ontario, Canada, M5G 1X8
        • Hospital for Sick Children
    • Quebec
      • Montreal, Quebec, Canada, H3T 1C5
        • Hopital Sainte Justine
      • Montreal, Quebec, Canada, H3H 1P3
        • McGill University Health Center - Montreal Children's Hospital
      • Sainte Foy, Quebec, Canada, GIV 4G2
        • Centre Hospitalier de l'Universite Laval
      • Sainte-Foy, Quebec, Canada, G1V 4G2
        • Laval University Medical Center
  • Netherlands
      • Groningen, Netherlands, 9713 EZ
        • Academisch Ziekenhuis Groningen
  • Puerto Rico
      • Santurce, Puerto Rico, 00912
        • San Jorge Childrens Hospital
  • Switzerland
      • Bern, Switzerland, CH 3010
        • Swiss Pediatric Oncology Group Bern
      • Geneva, Switzerland, 1211
        • Clinique de Pediatrie
      • Lausanne, Switzerland, CH-1011
        • Centre Hospitalier Universitaire Vaudois
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294-3300
        • University of Alabama at Birmingham Comprehensive Cancer Center
      • Mobile, Alabama, United States, 36688
        • MBCCOP - Gulf Coast
      • Mobile, Alabama, United States, 36617-2293
        • University of South Alabama Medical Center
    • Arizona
      • Tucson, Arizona, United States, 85724
        • Arizona Cancer Center
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • University of Arkansas for Medical Sciences
    • California
      • La Jolla, California, United States, 92093-0658
        • University of California San Diego Cancer Center
      • Palo Alto, California, United States, 94304
        • Lucile Packard Children's Hospital at Stanford
      • Sacramento, California, United States, 95816
        • Sutter Cancer center
      • Sacramento, California, United States, 95817
        • University of California Davis Medical Center
      • San Diego, California, United States, 92120
        • Kaiser Permanente-Southern California Permanente Medical Group
      • San Diego, California, United States, 92123-4282
        • Children's Hospital and Health Center
      • Santa Clara, California, United States, 95051-5386
        • Kaiser Permanente Medical Center - Santa Clara
    • Connecticut
      • New Haven, Connecticut, United States, 06520-8028
        • Yale Comprehensive Cancer Center
    • District of Columbia
      • Washington, District of Columbia, United States, 20307-5000
        • Walter Reed Army Medical Center
    • Florida
      • Fort Lauderdale, Florida, United States, 33316
        • Broward General Medical Center
      • Fort Myers, Florida, United States, 33908
        • Children's Hospital of Southwest Florida
      • Gainesville, Florida, United States, 32610-100277
        • Shands Hospital and Clinics, University of Florida
      • Jacksonville, Florida, United States, 32207
        • Nemours Children's Clinic
      • Miami, Florida, United States, 33136
        • Sylvester Cancer Center, University of Miami
      • Miami, Florida, United States, 33176-2197
        • Baptist Hospital of Miami
      • Miami, Florida, United States, 33155
        • Miami Children's Hospital
      • Miami, Florida, United States, 33136
        • University of Miami-Jackson Memorial Hospital Medical Center
      • Orlando, Florida, United States, 32803
        • Florida Hospital Cancer Institute
      • St. Petersburg, Florida, United States, 33701
        • All Children's Hospital
      • Tampa, Florida, United States, 33682-7757
        • CCOP - Florida Pediatric
      • West Palm Beach, Florida, United States, 33407
        • St. Mary's Hospital
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory University Hospital - Atlanta
      • Atlanta, Georgia, United States, 30322
        • Emory University School of Medicine
    • Hawaii
      • Honolulu, Hawaii, United States, 96859-5000
        • Tripler Army Medical Center
      • Honolulu, Hawaii, United States, 96813
        • Cancer Research Center of Hawaii
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Rush-Presbyterian-St. Luke's Medical Center
      • Chicago, Illinois, United States, 60614
        • Children's Memorial Hospital, Chicago
      • Oak Lawn, Illinois, United States, 60453
        • Hope Children's Hospital
      • Peoria, Illinois, United States, 61637
        • Saint Jude Midwest Affiliate
      • Peoria, Illinois, United States, 61602
        • CCOP - Illinois Oncology Research Association
    • Kansas
      • Kansas City, Kansas, United States, 66160-7357
        • University of Kansas Medical Center
      • Wichita, Kansas, United States, 67214-3882
        • CCOP - Wichita
      • Wichita, Kansas, United States, 67214
        • Via Christi Regional Medical Center
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
        • Tulane University School of Medicine
      • New Orleans, Louisiana, United States, 70121
        • CCOP - Ochsner
      • New Orleans, Louisiana, United States, 70112
        • MBCCOP - LSU Health Sciences Center
    • Maine
      • Bangor, Maine, United States, 04401
        • Eastern Maine Medical Center
      • Portland, Maine, United States, 04101
        • Maine Children's Cancer Program
    • Maryland
      • Baltimore, Maryland, United States, 21231-2410
        • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
      • Baltimore, Maryland, United States, 21201
        • Marlene & Stewart Greenebaum Cancer Center, University of Maryland
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Dana-Farber Cancer Institute
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital Cancer Center
      • Boston, Massachusetts, United States, 02111
        • Boston Floating Hospital Infants and Children
      • Worcester, Massachusetts, United States, 01655
        • University of Massachusetts Memorial Medical Center
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Children's Hospital of Michigan
      • Detroit, Michigan, United States, 48236
        • St. John Hospital and Medical Center
      • Flint, Michigan, United States, 48503
        • Hurley Medical Center
    • Mississippi
      • Jackson, Mississippi, United States, 39216-4505
        • University of Mississippi Medical Center
      • Keesler AFB, Mississippi, United States, 39534-2576
        • Keesler Medical Center - Keesler AFB
    • Missouri
      • Columbia, Missouri, United States, 65212
        • University of Missouri-Columbia Hospital and Clinics
      • Saint Louis, Missouri, United States, 63110
        • Washington University School of Medicine
      • Saint Louis, Missouri, United States, 63104
        • Cardinal Glennon Children's Hospital
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756-0002
        • Norris Cotton Cancer Center
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Hackensack University Medical Center
      • Hackensack, New Jersey, United States, 07601
        • CCOP - Northern New Jersey
    • New Mexico
      • Albuquerque, New Mexico, United States, 87131
        • University of New Mexico School of Medicine
    • New York
      • Buffalo, New York, United States, 14263-0001
        • Roswell Park Cancer Institute
      • New Hyde Park, New York, United States, 11042
        • Schneider Children's Hospital
      • New York, New York, United States, 10029
        • Mount Sinai School of Medicine
      • Rochester, New York, United States, 14642
        • University of Rochester Cancer Center
      • Stony Brook, New York, United States, 11790-7775
        • State University of New York Health Sciences Center - Stony Brook
      • Syracuse, New York, United States, 13210
        • State University of New York - Upstate Medical University
    • North Carolina
      • Asheville, North Carolina, United States, 28801
        • Mission Saint Joseph's Health System
      • Charlotte, North Carolina, United States, 28232-2861
        • Carolinas Medical Center
      • Charlotte, North Carolina, United States, 28233-3549
        • Presbyterian Healthcare
      • Durham, North Carolina, United States, 27710
        • Duke Comprehensive Cancer Center
      • Greenville, North Carolina, United States, 27858-4354
        • East Carolina University School of Medicine
      • Winston-Salem, North Carolina, United States, 27157-1082
        • Comprehensive Cancer Center at Wake Forest University
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73126-0307
        • Oklahoma Memorial Hospital
      • Tulsa, Oklahoma, United States, 74136
        • Natalie Warren Bryant Cancer Center
    • Oregon
      • Portland, Oregon, United States, 97213
        • CCOP - Columbia River Program
      • Portland, Oregon, United States, 97227
        • Legacy Emanuel Hospital and Health Center
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19134-1095
        • St. Christopher's Hospital for Children
    • South Carolina
      • Charleston, South Carolina, United States, 29425-0721
        • Medical University of South Carolina
      • Greenville, South Carolina, United States, 29605
        • Children's Hospital of Greenville Hospital System
    • Tennessee
      • Johnson City, Tennessee, United States, 37614-0622
        • James H. Quillen College of Medicine
      • Memphis, Tennessee, United States, 38105-2794
        • Saint Jude Children's Research Hospital
    • Texas
      • Corpus Christi, Texas, United States, 78466
        • Driscoll Children's Hospital
      • Dallas, Texas, United States, 75230
        • Medical City Dallas Hospital
      • Dallas, Texas, United States, 75235-9154
        • Simmons Cancer Center - Dallas
      • Dallas, Texas, United States, 75230-2503
        • Texas Oncology P.A.
      • Fort Worth, Texas, United States, 76104
        • Cook Children's Medical Center - Fort Worth
      • Galveston, Texas, United States, 77555-0209
        • University of Texas Medical Branch
      • Houston, Texas, United States, 77030
        • Baylor College of Medicine
      • Lackland Air Force Base, Texas, United States, 78236-5300
        • San Antonio Military Pediatric Cancer and Blood Disorders Center
      • San Antonio, Texas, United States, 78284-7811
        • University of Texas Health Science Center at San Antonio
      • San Antonio, Texas, United States, 78229-3900
        • MBCCOP - South Texas Pediatric
      • Temple, Texas, United States, 76508
        • Scott and White Clinic
    • Vermont
      • Burlington, Vermont, United States, 05401-3498
        • Vermont Cancer Center
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • Cancer Center at the University of Virginia
      • Falls Church, Virginia, United States, 22042-3300
        • Inova Fairfax Hospital
      • Portsmouth, Virginia, United States, 23708-2197
        • Naval Medical Center, Portsmouth
      • Richmond, Virginia, United States, 23298-0037
        • Massey Cancer Center
      • Roanoke, Virginia, United States, 24019
        • Carilion Roanoke Community Hospital
    • Washington
      • Tacoma, Washington, United States, 98431-5000
        • Madigan Army Medical Center
    • West Virginia
      • Charleston, West Virginia, United States, 25304
        • West Virginia University Medical School-Charleston
      • Morgantown, West Virginia, United States, 26506-9300
        • West Virginia University Hospitals
    • Wisconsin
      • Green Bay, Wisconsin, United States, 54307-3508
        • St. Vincent Hospital
      • Milwaukee, Wisconsin, United States, 53226
        • Midwest Children's Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 22 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
Drug: leucovorin calcium
Given IV
Other Names:
  • LCV
  • Wellcovorin
  • citrovorum factor
  • folinic acid
  • NSC #3590
Drug: cyclophosphamide
Given IV
Other Names:
  • Cytoxan
  • CTX
  • IND #7089
  • NSC #26271
Drug: methotrexate
Given IV
Other Names:
  • amethopterin
  • MTX
  • IND #4291
  • NSC #740
Drug: cytarabine
Given IV
Other Names:
  • Ara-C
  • Cytosar
  • cytosine arabinoside
  • NSC #638
Drug: doxorubicin hydrochloride
Given IV
Other Names:
  • Adriamycin
  • NSC #123127
  • IND #7038
Drug: vincristine sulfate
Given IV
Other Names:
  • VCR
  • Oncovin
  • IND #7161
  • NSC #67574
Biological: filgrastim
Given IV
Other Names:
  • G-CSF
  • r-metHuG-CSF
  • Neupogen
  • NSC #614629
  • GRANULOCYTE COLONY-STIMULATING FACTOR
Drug: dexamethasone
Given IV
Other Names:
  • NSC #034521
  • DECADRON
Experimental: 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
Drug: leucovorin calcium
Given IV
Other Names:
  • LCV
  • Wellcovorin
  • citrovorum factor
  • folinic acid
  • NSC #3590
Drug: cyclophosphamide
Given IV
Other Names:
  • Cytoxan
  • CTX
  • IND #7089
  • NSC #26271
Drug: methotrexate
Given IV
Other Names:
  • amethopterin
  • MTX
  • IND #4291
  • NSC #740
Drug: cytarabine
Given IV
Other Names:
  • Ara-C
  • Cytosar
  • cytosine arabinoside
  • NSC #638
Drug: doxorubicin hydrochloride
Given IV
Other Names:
  • Adriamycin
  • NSC #123127
  • IND #7038
Drug: vincristine sulfate
Given IV
Other Names:
  • VCR
  • Oncovin
  • IND #7161
  • NSC #67574
Biological: filgrastim
Given IV
Other Names:
  • G-CSF
  • r-metHuG-CSF
  • Neupogen
  • NSC #614629
  • GRANULOCYTE COLONY-STIMULATING FACTOR
Drug: dexamethasone
Given IV
Other Names:
  • NSC #034521
  • DECADRON
Experimental: 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
Drug: leucovorin calcium
Given IV
Other Names:
  • LCV
  • Wellcovorin
  • citrovorum factor
  • folinic acid
  • NSC #3590
Drug: cyclophosphamide
Given IV
Other Names:
  • Cytoxan
  • CTX
  • IND #7089
  • NSC #26271
Drug: methotrexate
Given IV
Other Names:
  • amethopterin
  • MTX
  • IND #4291
  • NSC #740
Drug: etoposide
Given IV
Other Names:
  • VP-16
  • VePesid
  • NSC #141540
  • IND #9197
Drug: cytarabine
Given IV
Other Names:
  • Ara-C
  • Cytosar
  • cytosine arabinoside
  • NSC #638
Drug: doxorubicin hydrochloride
Given IV
Other Names:
  • Adriamycin
  • NSC #123127
  • IND #7038
Drug: vincristine sulfate
Given IV
Other Names:
  • VCR
  • Oncovin
  • IND #7161
  • NSC #67574
Biological: filgrastim
Given IV
Other Names:
  • G-CSF
  • r-metHuG-CSF
  • Neupogen
  • NSC #614629
  • GRANULOCYTE COLONY-STIMULATING FACTOR
Drug: dexamethasone
Given IV
Other Names:
  • NSC #034521
  • DECADRON
Drug: ifosfamide
Given IV
Other Names:
  • IFX
  • NSC #109724
  • IFOS
  • IND #7887
Experimental: 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
Drug: leucovorin calcium
Given IV
Other Names:
  • LCV
  • Wellcovorin
  • citrovorum factor
  • folinic acid
  • NSC #3590
Drug: cyclophosphamide
Given IV
Other Names:
  • Cytoxan
  • CTX
  • IND #7089
  • NSC #26271
Drug: methotrexate
Given IV
Other Names:
  • amethopterin
  • MTX
  • IND #4291
  • NSC #740
Drug: cytarabine
Given IV
Other Names:
  • Ara-C
  • Cytosar
  • cytosine arabinoside
  • NSC #638
Drug: doxorubicin hydrochloride
Given IV
Other Names:
  • Adriamycin
  • NSC #123127
  • IND #7038
Drug: vincristine sulfate
Given IV
Other Names:
  • VCR
  • Oncovin
  • IND #7161
  • NSC #67574
Biological: filgrastim
Given IV
Other Names:
  • G-CSF
  • r-metHuG-CSF
  • Neupogen
  • NSC #614629
  • GRANULOCYTE COLONY-STIMULATING FACTOR
Drug: dexamethasone
Given IV
Other Names:
  • NSC #034521
  • DECADRON
Experimental: 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
Drug: leucovorin calcium
Given IV
Other Names:
  • LCV
  • Wellcovorin
  • citrovorum factor
  • folinic acid
  • NSC #3590
Drug: cyclophosphamide
Given IV
Other Names:
  • Cytoxan
  • CTX
  • IND #7089
  • NSC #26271
Drug: methotrexate
Given IV
Other Names:
  • amethopterin
  • MTX
  • IND #4291
  • NSC #740
Drug: etoposide
Given IV
Other Names:
  • VP-16
  • VePesid
  • NSC #141540
  • IND #9197
Drug: cytarabine
Given IV
Other Names:
  • Ara-C
  • Cytosar
  • cytosine arabinoside
  • NSC #638
Drug: doxorubicin hydrochloride
Given IV
Other Names:
  • Adriamycin
  • NSC #123127
  • IND #7038
Drug: vincristine sulfate
Given IV
Other Names:
  • VCR
  • Oncovin
  • IND #7161
  • NSC #67574
Biological: filgrastim
Given IV
Other Names:
  • G-CSF
  • r-metHuG-CSF
  • Neupogen
  • NSC #614629
  • GRANULOCYTE COLONY-STIMULATING FACTOR
Drug: dexamethasone
Given IV
Other Names:
  • NSC #034521
  • DECADRON
Drug: ifosfamide
Given IV
Other Names:
  • IFX
  • NSC #109724
  • IFOS
  • IND #7887

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Event-free survival
Time Frame: 1 year
Assess the effect of high dose methotrexate in combination with standard treatment per the POG 9317 protocol on 1-year event-free survival (EFS), monitor and assess toxicity, and estimate the hospitalization costs for the treatment of toxicity related side effects.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Children's Oncology Group

Collaborators

National Cancer Institute (NCI)

Investigators

  • Study Chair: Hazem H. Mahmoud, MD, Carol G. Simon Cancer Center at Morristown Memorial Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2000

Primary Completion (Actual)

March 1, 2004

Study Completion (Actual)

September 1, 2006

Study Registration Dates

First Submitted

July 5, 2000

First Submitted That Met QC Criteria

May 20, 2003

First Posted (Estimate)

May 21, 2003

Study Record Updates

Last Update Posted (Estimate)

August 21, 2013

Last Update Submitted That Met QC Criteria

August 19, 2013

Last Verified

August 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 9917
  • COG-9917 (Other Identifier: Children's Oncology Group)
  • CDR0000067965 (Other Identifier: Clinical Trials.gov)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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