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Irinotecan Hydrochloride and Temozolomide With Temsirolimus or Dinutuximab in Treating Younger Patients With Refractory or Relapsed Neuroblastoma

NCT01767194 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 73

Last updated 2022-10-24

Study results available
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Summary

This randomized phase II trial studies how well irinotecan hydrochloride and temozolomide with temsirolimus or dinutuximab work in treating younger patients with neuroblastoma that has returned or does not respond to treatment. Drugs used in chemotherapy, such as irinotecan hydrochloride and temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Temsirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as dinutuximab, may find tumor cells and help kill them or carry tumor-killing substances to them. It is not yet known whether giving irinotecan hydrochloride and temozolomide together with temsirolimus or dinutuximab is more effective in treating neuroblastoma.

Conditions

  • Ganglioneuroblastoma
  • Recurrent Neuroblastoma

Interventions

BIOLOGICAL

Dinutuximab

Given IV

DRUG

Irinotecan Hydrochloride

Given IV

OTHER

Laboratory Biomarker Analysis

Optional correlative studies

BIOLOGICAL

Sargramostim

Given SC or IV

DRUG

Temozolomide

Given PO

DRUG

Temsirolimus

Given IV

Sponsors & Collaborators

  • United Therapeutics

    collaborator INDUSTRY

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • Rajen Mody · Children's Oncology Group

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-02-12
Primary Completion
2018-06-30
Completion
2022-09-30

Countries

  • United States
  • Australia
  • Canada
  • New Zealand
  • Puerto Rico

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01767194 on ClinicalTrials.gov