NCT00101205

Brief Summary

This phase I trial is studying the side effects and best dose of oxaliplatin and etoposide in treating young patients with recurrent or refractory solid tumors or lymphomas. Drugs used in chemotherapy, such as oxaliplatin and etoposide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Oxaliplatin may also help etoposide work better by making cancer cells more sensitive to the drug. Giving oxaliplatin together with etoposide may kill more cancer cells.

Trial Health

35
At Risk

Trial Health Score

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

Enrollment
40

participants targeted

Target at P50-P75 for phase_1

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

Study Start

First participant enrolled

November 1, 2004

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 7, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 10, 2005

Completed
7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
Last Updated

February 24, 2014

Status Verified

April 1, 2013

Enrollment Period

7.2 years

First QC Date

January 7, 2005

Last Update Submit

February 21, 2014

Conditions

Angioimmunoblastic T-cell LymphomaB-cell Childhood Acute Lymphoblastic LeukemiaB-cell Chronic Lymphocytic LeukemiaChildhood Burkitt LymphomaChildhood Diffuse Large Cell LymphomaChildhood Grade III Lymphomatoid GranulomatosisChildhood Immunoblastic Large Cell LymphomaChildhood Nasal Type Extranodal NK/T-cell LymphomaHepatosplenic T-cell LymphomaIntraocular LymphomaNoncutaneous Extranodal LymphomaPeripheral T-cell LymphomaRecurrent Childhood Acute Lymphoblastic LeukemiaRecurrent Childhood Anaplastic Large Cell LymphomaRecurrent Childhood Grade III Lymphomatoid GranulomatosisRecurrent Childhood Large Cell LymphomaRecurrent Childhood Lymphoblastic LymphomaRecurrent Childhood Small Noncleaved Cell LymphomaRecurrent Cutaneous T-cell Non-Hodgkin LymphomaRecurrent Mycosis Fungoides/Sezary SyndromeRecurrent/Refractory Childhood Hodgkin LymphomaRefractory Chronic Lymphocytic LeukemiaRefractory Hairy Cell LeukemiaSmall Intestine LymphomaT-cell Childhood Acute Lymphoblastic LeukemiaT-cell Large Granular Lymphocyte LeukemiaUnspecified Childhood Solid Tumor, Protocol Specific

Outcome Measures

Primary Outcomes (2)

  • MTD of the combination of oxaliplatin and etoposide assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 3.0

    21 days

  • MTD of the addition of ifosfamide to the combination of oxaliplatin and etoposide assessed by CTCAE version 3.0

    21 days

Study Arms (1)

Arm I

EXPERIMENTAL

Patients receive oxaliplatin IV over 2 hours on day 1 and etoposide IV over 1 hour on days 1-3. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Drug: oxaliplatinDrug: etoposide

Interventions

oxaliplatinDRUG

Given IV

Also known as: 1-OHP, Dacotin, Dacplat, Eloxatin, L-OHP
Arm I
etoposideDRUG

Given IV

Also known as: EPEG, VP-16, VP-16-213
Arm I

Eligibility Criteria

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

You may qualify if:

  • Life expectancy \> 8 weeks
  • Albumin \> 2 g/dL
  • Histologically confirmed diagnosis of 1 of the following: solid tumor; histologic verification not required for brainstem tumors or optic pathway tumors; lymphoma; recurrent or refractory to conventional therapy OR no known effective therapy exists; bone marrow involvement allowed
  • Performance Status: Karnofsky \>= 50 % (patients \> 10 years of age) OR Lansky \>= 50% (patients for =\< 10 years of age)
  • Absolute neutrophil count \> 1,000/mm\^3
  • Platelet count \> 100,000/mm\^3 (transfusion independent)
  • Hemoglobin \> 8 g/dL (transfusion allowed)
  • ALT \< 5.0 times ULN
  • Creatinine normal OR glomerular filtration rate \>= 80 mL/min/1.73 m\^2
  • Calcium normal (electrolyte supplements allowed)
  • Echocardiogram and EKG normal
  • Shortening fraction \>= 27% OR ejection fraction \> 50%
  • No evidence of dyspnea at rest
  • No exercise intolerance
  • Pulse oximetry \> 94% on room air
  • +13 more criteria

You may not qualify if:

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No uncontrolled infection
  • No history of life-threatening hypersensitivity to platinum-containing agents
  • No prior oxaliplatin
  • No other concurrent investigational agents
  • No other concurrent anticancer therapy
  • Inability or unwillingness of research participant or legal guardian/representative to give written informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Jude Children's Research Hospital

Memphis, Tennessee, 38105, United States

Location

MeSH Terms

Conditions

Immunoblastic LymphadenopathyLeukemia, Lymphocytic, Chronic, B-CellBurkitt LymphomaLymphoma, Large B-Cell, DiffuseLymphoma, Extranodal NK-T-CellIntraocular LymphomaLymphoma, T-Cell, PeripheralPrecursor Cell Lymphoblastic Leukemia-LymphomaLymphoma, Large-Cell, AnaplasticDendritic Cell Sarcoma, InterdigitatingLymphoma, T-Cell, CutaneousMycosis FungoidesSezary SyndromeRecurrenceLeukemia, Hairy CellLeukemia, Large Granular Lymphocytic

Interventions

OxaliplatinEtoposide

Condition Hierarchy (Ancestors)

LymphadenopathyLymphatic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersImmunoproliferative DisordersImmune System DiseasesLeukemia, B-CellLeukemia, LymphoidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsEpstein-Barr Virus InfectionsHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsTumor Virus InfectionsLymphoma, B-CellLymphoma, Non-HodgkinLymphomaLymphoma, T-CellEye NeoplasmsNeoplasms by SiteHistiocytic Disorders, MalignantHistiocytosisLeukemia, T-Cell

Intervention Hierarchy (Ancestors)

Coordination ComplexesOrganic ChemicalsPodophyllotoxinTetrahydronaphthalenesNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPolycyclic CompoundsGlucosidesGlycosidesCarbohydrates

Study Officials

  • Lisa McGregor

    St. Jude Children's Research Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 7, 2005

First Posted

January 10, 2005

Study Start

November 1, 2004

Primary Completion

January 1, 2012

Last Updated

February 24, 2014

Record last verified: 2013-04

Locations

US(1)