NCT00101270

Brief Summary

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

Trial Health

80
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at P25-P50 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

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
2 months until next milestone

Study Start

First participant enrolled

March 1, 2005

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2007

Completed
Last Updated

June 5, 2013

Status Verified

June 1, 2013

Enrollment Period

2.5 years

First QC Date

January 7, 2005

Last Update Submit

June 4, 2013

Conditions

Childhood Burkitt LymphomaChildhood Central Nervous System Germ Cell TumorChildhood Diffuse Large Cell LymphomaChildhood Grade III Lymphomatoid GranulomatosisChildhood Immunoblastic Large Cell LymphomaRecurrent Childhood Brain Stem GliomaRecurrent Childhood Cerebellar AstrocytomaRecurrent Childhood Cerebral AstrocytomaRecurrent Childhood EpendymomaRecurrent Childhood Grade III Lymphomatoid GranulomatosisRecurrent Childhood Large Cell LymphomaRecurrent Childhood Liver CancerRecurrent Childhood Lymphoblastic LymphomaRecurrent Childhood Malignant Germ Cell TumorRecurrent Childhood MedulloblastomaRecurrent Childhood RhabdomyosarcomaRecurrent Childhood Small Noncleaved Cell LymphomaRecurrent Childhood Soft Tissue SarcomaRecurrent Childhood Supratentorial Primitive Neuroectodermal TumorRecurrent Childhood Visual Pathway GliomaRecurrent Colon CancerRecurrent Ewing Sarcoma/Peripheral Primitive Neuroectodermal TumorRecurrent MelanomaRecurrent Nasopharyngeal CancerRecurrent NeuroblastomaRecurrent OsteosarcomaRecurrent Wilms Tumor and Other Childhood Kidney TumorsRecurrent/Refractory Childhood Hodgkin LymphomaUnspecified Childhood Solid Tumor, Protocol Specific

Outcome Measures

Primary Outcomes (1)

  • MTD of oxaliplatin, defined as the maximum dose at which fewer than one-third of patients experience DLT

    Graded using the NCI CTCAE version 3.0.

    21 days

Secondary Outcomes (1)

  • Overall response assessed using RECIST criteria

    Up to 12 months

Study Arms (1)

Treatment (irinotecan hydrochloride, oxaliplatin)

EXPERIMENTAL

Patients receive oxaliplatin IV over 2 hours on days 1 and 8 and irinotecan IV over 1 hour on days 1-5 and 8-12. Treatment repeats every 21 days for up to 17 courses in the absence of disease progression or unacceptable toxicity.

Drug: irinotecan hydrochlorideDrug: oxaliplatin

Interventions

irinotecan hydrochlorideDRUG

Given IV

Also known as: Campto, Camptosar, CPT-11, irinotecan, U-101440E
Treatment (irinotecan hydrochloride, oxaliplatin)
oxaliplatinDRUG

Given IV

Also known as: 1-OHP, Dacotin, Dacplat, Eloxatin, L-OHP
Treatment (irinotecan hydrochloride, oxaliplatin)

Eligibility Criteria

Age1 Year - 21 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Histologically confirmed refractory malignant solid tumor or lymphoma
  • Intrinsic brain stem tumors and optic pathway tumors do not require histologic verification
  • No known curative therapy or therapy proven to prolong survival with an acceptable quality of life exists
  • Measurable or evaluable disease
  • Evaluable disease is defined as a tumor that cannot be measured using a ruler or calipers, but can be assessed to determine disease progression or complete response, such as any of the following:
  • Positive lesions on metaiodobenzylguanidine (MIBG) or bone scan
  • Metastatic bone marrow disease
  • Elevated tumor markers
  • Presence of a malignant pleural effusion
  • No leukemia
  • Performance status - Karnofsky 50-100% (for patients \> 10 years of age)
  • Performance status - Lansky 50-100% (for patients ≤ 10 years of age)
  • Not specified
  • Absolute neutrophil count ≥ 1,000/mm\^3
  • Platelet count ≥ 100,000/mm\^3 (transfusion independent)
  • +56 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

COG Phase I Consortium

Arcadia, California, 91006-3776, United States

Location

MeSH Terms

Conditions

Burkitt LymphomaLymphoma, Large B-Cell, DiffuseAstrocytomaFamilial ependymomaDendritic Cell Sarcoma, InterdigitatingMedulloblastomaOptic Nerve GliomaColonic NeoplasmsNeuroectodermal Tumors, Primitive, PeripheralMelanomaNasopharyngeal NeoplasmsNeuroblastomaOsteosarcomaWilms TumorRecurrence

Interventions

IrinotecanOxaliplatin

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 DiseasesGliomaNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms, Glandular and EpithelialNeoplasms, Nerve TissueHistiocytic Disorders, MalignantHistiocytosisNeuroectodermal Tumors, PrimitiveOptic Nerve NeoplasmsCranial Nerve NeoplasmsNervous System NeoplasmsNeoplasms by SitePeripheral Nervous System NeoplasmsCranial Nerve DiseasesNervous System DiseasesOptic Nerve DiseasesEye DiseasesColorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesNeuroendocrine TumorsNevi and MelanomasSkin NeoplasmsSkin DiseasesSkin and Connective Tissue DiseasesPharyngeal NeoplasmsOtorhinolaryngologic NeoplasmsHead and Neck NeoplasmsNasopharyngeal DiseasesPharyngeal DiseasesStomatognathic DiseasesOtorhinolaryngologic DiseasesNeoplasms, Bone TissueNeoplasms, Connective TissueNeoplasms, Connective and Soft TissueSarcomaNeoplasms, Complex and MixedKidney NeoplasmsUrologic NeoplasmsUrogenital NeoplasmsNeoplastic Syndromes, HereditaryFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

CamptothecinAlkaloidsHeterocyclic CompoundsCoordination ComplexesOrganic Chemicals

Study Officials

  • Lisa McGregor

    COG Phase I Consortium

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
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

March 1, 2005

Primary Completion

September 1, 2007

Last Updated

June 5, 2013

Record last verified: 2013-06

Locations

US(1)