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Studies of Temozolomide in Combination With Topotecan in Refractory and Relapsed Paediatric Solid Tumours

NCT00918320 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 129

Last updated 2016-01-26

No results posted yet for this study

Summary

The purpose of the study is to determine whether the combination of Hycamtin (Topotecan) and Temozolomide is effective in the treatment of relapsed and refractory neuroblastoma and other paediatric solid tumors.

Conditions

Interventions

DRUG

Temozolomide/Hycamtin (Topotecan)

Temozolomide: bottles containing 5 capsules of 5, 20, 100 and 250 mg Hycamtin (Topotecan): a lyophilisate for infusion in vials containing 4 mg Patients receive during 5 days (Day 1 to Day 5): Temozolomide 150 mg/m2/day per os, dose will be adjusted to the closest 5 mg, followed one hour later by Hycamtin(Topotecan) 0.75 mg/m2/day as an intravenous infusion over 30 minutes

Sponsors & Collaborators

  • St. Anna Kinderkrebsforschung

    collaborator OTHER

  • Catholic University of the Sacred Heart

    collaborator OTHER

  • Erasmus Medical Center

    collaborator OTHER

  • Gustave Roussy, Cancer Campus, Grand Paris

    lead OTHER

Principal Investigators

  • Birgit Geoerger, MD, PHD · Gustave Roussy, Cancer Campus, Grand Paris

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
6 Months
Max Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-06-30
Primary Completion
2013-10-31
Completion
2015-08-31

Countries

  • France

Study Locations

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Entities

Diseases
Companies

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 NCT00918320 on ClinicalTrials.gov