NCT00091182

Brief Summary

This phase II trial is studying how well oxaliplatin works in treating young patients with recurrent solid tumors that have not responded to previous treatment. Drugs used in chemotherapy, such as oxaliplatin, work in different ways to stop tumor cells from dividing so they stop growing or die.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
180

participants targeted

Target at P75+ for phase_2

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 7, 2004

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 9, 2004

Completed
22 days until next milestone

Study Start

First participant enrolled

October 1, 2004

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2006

Completed
Last Updated

June 5, 2013

Status Verified

June 1, 2013

Enrollment Period

1.3 years

First QC Date

September 7, 2004

Last Update Submit

June 4, 2013

Conditions

Childhood Central Nervous System Germ Cell TumorChildhood Extragonadal Germ Cell TumorChildhood HepatoblastomaChildhood Hepatocellular CarcinomaChildhood High-grade Cerebral AstrocytomaChildhood Low-grade Cerebral AstrocytomaChildhood Malignant Ovarian Germ Cell TumorChildhood Malignant Testicular Germ Cell TumorChildhood TeratomaRecurrent Adrenocortical CarcinomaRecurrent Childhood Brain Stem GliomaRecurrent Childhood Cerebellar AstrocytomaRecurrent Childhood Cerebral AstrocytomaRecurrent Childhood EpendymomaRecurrent Childhood Liver CancerRecurrent Childhood Malignant Germ Cell TumorRecurrent Childhood RhabdomyosarcomaRecurrent Childhood Soft Tissue SarcomaRecurrent Childhood Visual Pathway and Hypothalamic GliomaRecurrent Colon CancerRecurrent Ewing Sarcoma/Peripheral Primitive Neuroectodermal TumorRecurrent Nasopharyngeal CancerRecurrent NeuroblastomaRecurrent OsteosarcomaRecurrent Rectal CancerRecurrent Renal Cell Cancer

Outcome Measures

Primary Outcomes (1)

  • Response rate

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

    Up to 3 years

Study Arms (1)

Arm I

EXPERIMENTAL

Patients receive oxaliplatin IV over 2 hours on day 1. Treatment repeats every 21 days for up to 17 courses in the absence of disease progression or unacceptable toxicity.

Drug: oxaliplatin

Interventions

oxaliplatinDRUG

Given IV

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

Eligibility Criteria

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

You may qualify if:

  • Histologically confirmed\* solid tumor, including any of the following:
  • Ewing's sarcoma/peripheral primitive neuroectodermal tumor (PNET)
  • Osteosarcoma
  • Rhabdomyosarcoma
  • Neuroblastoma
  • High-grade astrocytoma
  • Low-grade astrocytoma
  • Glioblastoma multiforme
  • Ependymoma
  • Hepatoblastoma
  • Germ cell tumors of any site
  • Rare tumors of interest, including any of the following:
  • Soft tissue sarcoma
  • Hepatocellular carcinoma
  • Childhood/adolescent colorectal carcinoma
  • +45 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

HepatoblastomaAstrocytomaOvarian Germ Cell CancerTesticular NeoplasmsTeratomaAdrenocortical CarcinomaFamilial ependymomaOptic Nerve GliomaColonic NeoplasmsNeuroectodermal Tumors, Primitive, PeripheralNasopharyngeal NeoplasmsNeuroblastomaOsteosarcomaRectal NeoplasmsCarcinoma, Renal Cell

Interventions

Oxaliplatin

Condition Hierarchy (Ancestors)

Neoplasms, Complex and MixedNeoplasms by Histologic TypeNeoplasmsGliomaNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms, Glandular and EpithelialNeoplasms, Nerve TissueEndocrine Gland NeoplasmsNeoplasms by SiteGenital Neoplasms, MaleUrogenital NeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital DiseasesEndocrine System DiseasesTesticular DiseasesGonadal DisordersAdenocarcinomaCarcinomaAdrenal Cortex NeoplasmsAdrenal Gland NeoplasmsAdrenal Cortex DiseasesAdrenal Gland DiseasesOptic Nerve NeoplasmsCranial Nerve NeoplasmsNervous System NeoplasmsPeripheral Nervous System NeoplasmsCranial Nerve DiseasesNervous System DiseasesOptic Nerve DiseasesEye DiseasesColorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesNeuroectodermal Tumors, PrimitivePharyngeal NeoplasmsOtorhinolaryngologic NeoplasmsHead and Neck NeoplasmsNasopharyngeal DiseasesPharyngeal DiseasesStomatognathic DiseasesOtorhinolaryngologic DiseasesNeoplasms, Bone TissueNeoplasms, Connective TissueNeoplasms, Connective and Soft TissueSarcomaRectal DiseasesKidney NeoplasmsUrologic NeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsKidney DiseasesUrologic Diseases

Intervention Hierarchy (Ancestors)

Coordination ComplexesOrganic Chemicals

Study Officials

  • Orren Beaty

    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

September 7, 2004

First Posted

September 9, 2004

Study Start

October 1, 2004

Primary Completion

February 1, 2006

Last Updated

June 5, 2013

Record last verified: 2013-06

Locations

US(1)