NCT00058461

Brief Summary

This phase II trial is studying how well rituximab together with ifosfamide, carboplatin, and etoposide works in treating young patients with recurrent or refractory non-Hodgkin's lymphoma or acute lymphoblastic leukemia. Chemotherapy drugs, such as ifosfamide, carboplatin, and etoposide, work in different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Combining ifosfamide, carboplatin, and etoposide with rituximab may kill more cancer cells.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
82

participants targeted

Target at P50-P75 for phase_2

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 7, 2003

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 9, 2003

Completed
7 months until next milestone

Study Start

First participant enrolled

November 1, 2003

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2007

Completed
Last Updated

October 8, 2013

Status Verified

October 1, 2013

Enrollment Period

3.3 years

First QC Date

April 7, 2003

Last Update Submit

October 7, 2013

Conditions

B-cell Childhood Acute Lymphoblastic LeukemiaChildhood Burkitt LymphomaChildhood Diffuse Large Cell LymphomaChildhood Immunoblastic Large Cell LymphomaL3 Childhood Acute Lymphoblastic LeukemiaRecurrent Childhood Acute Lymphoblastic LeukemiaRecurrent Childhood Large Cell LymphomaRecurrent Childhood Lymphoblastic LymphomaRecurrent Childhood Small Noncleaved Cell Lymphoma

Outcome Measures

Primary Outcomes (3)

  • Response rate determined by physical exam and appropriate imaging studies

    Response rates and confidence intervals will be constructed according to the method of Chang and O'Brien.

    Up to 3 years

  • Relapse-free survival rate

    Estimated by the Kaplan-Meier method.

    Up to 3 years

  • Toxicity as assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE)

    Up to 3 years

Secondary Outcomes (1)

  • CD34 cells mobilization by flow cytometry

    At the completion of 2 courses of treatment

Study Arms (1)

Treatment (chemotherapy, rituximab)

EXPERIMENTAL

Patients receive ifosfamide IV over 2 hours and etoposide IV over 1 hour on days 3-5, rituximab IV on days 1 and 3, and carboplatin IV over 1 hour on day 3. Patients receive filgrastim (G-CSF) subcutaneously once daily beginning on day 6 and continuing until blood counts recover. Patients also receive intrathecal (IT) chemotherapy comprising methotrexate and cytarabine. Patients with B-cell large cell lymphoma and negative CSF cytology receive IT chemotherapy on day 3 of the first course only. Patients with small non-cleaved cell lymphoma or B-cell acute lymphoblastic leukemia and negative CSF cytology receive IT chemotherapy on day 3. All patients with positive CSF cytology receive IT chemotherapy on days 3, 10, and 17 of the first and second courses. Treatment repeats every 23 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.

Drug: ifosfamideDrug: etoposideBiological: rituximabDrug: carboplatinBiological: filgrastimDrug: methotrexateDrug: cytarabineOther: laboratory biomarker analysis

Interventions

ifosfamideDRUG

Given IV

Treatment (chemotherapy, rituximab)
etoposideDRUG

Given IV

Treatment (chemotherapy, rituximab)
rituximabBIOLOGICAL

Given IV

Treatment (chemotherapy, rituximab)
carboplatinDRUG

Given IV

Treatment (chemotherapy, rituximab)
filgrastimBIOLOGICAL

Given SC

Treatment (chemotherapy, rituximab)
methotrexateDRUG

Given IT

Treatment (chemotherapy, rituximab)
cytarabineDRUG

Given IT

Treatment (chemotherapy, rituximab)
laboratory biomarker analysisOTHER

Correlative studies

Treatment (chemotherapy, rituximab)

Eligibility Criteria

AgeUp to 21 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Histologically confirmed B-cell non-Hodgkin's lymphoma OR acute lymphoblastic leukemia
  • CD20+ (confirmed by flow cytometry of tumor tissue, involved marrow, or CD20 immunostaining)
  • The following histologies are generally CD20+ and are eligible:
  • Diffuse large B-cell lymphoma, mediastinal (thymic) large B-cell lymphoma, or follicular lymphoma, grade III (rare), documented by flow cytometry or appropriate immunohistochemistry, any stage
  • Burkitt's lymphoma or atypical Burkitt's/Burkitt-like lymphoma, any stage
  • B-cell acute lymphoblastic leukemia, with FABL3 morphology and/or demonstration of surface immunoglobin by flow cytometry
  • Atypical precursor B-cell lymphoblastic lymphoma or other unusual histologies that are CD20+
  • Measurable disease by clinical, radiographic, or histologic criteria
  • Must be in first or later recurrence or have disease that is primarily refractory to conventional therapy
  • No isolated CNS disease
  • Performance status - ECOG 0-2
  • At least 2 months
  • Absolute neutrophil count ≥ 1,000/mm\^3\*
  • Platelet count ≥ 100,000/mm\^3 (transfusion independent)\*
  • Hemoglobin ≥ 10.0 g/dL (RBC transfusion allowed)\*
  • +28 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Oncology Group

Arcadia, California, 91006-3776, United States

Location

MeSH Terms

Conditions

Burkitt LymphomaLymphoma, Large B-Cell, DiffusePrecursor Cell Lymphoblastic Leukemia-LymphomaDendritic Cell Sarcoma, Interdigitating

Interventions

IfosfamideEtoposideRituximabCarboplatinFilgrastimMethotrexateCytarabine

Condition Hierarchy (Ancestors)

Epstein-Barr Virus InfectionsHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsTumor Virus InfectionsLymphoma, B-CellLymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLeukemia, LymphoidLeukemiaHematologic DiseasesHistiocytic Disorders, MalignantHistiocytosis

Intervention Hierarchy (Ancestors)

CyclophosphamidePhosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsOrganic ChemicalsPhosphoramidesOrganophosphorus CompoundsOxazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPodophyllotoxinTetrahydronaphthalenesNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicPolycyclic CompoundsGlucosidesGlycosidesCarbohydratesAntibodies, Monoclonal, Murine-DerivedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsCoordination ComplexesGranulocyte Colony-Stimulating FactorColony-Stimulating FactorsGlycoproteinsGlycoconjugatesHematopoietic Cell Growth FactorsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesBiological FactorsAminopterinPterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingCytidinePyrimidine NucleosidesPyrimidinesArabinonucleosidesNucleosidesNucleic Acids, Nucleotides, and Nucleosides

Study Officials

  • Timothy Griffin

    Children's Oncology Group

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 7, 2003

First Posted

April 9, 2003

Study Start

November 1, 2003

Primary Completion

March 1, 2007

Last Updated

October 8, 2013

Record last verified: 2013-10

Locations

US(1)