Temozolomide in Association With Topotecan in Refractory or Relapsed Malignant Tumors in Children and Adolescents

This study has been completed.

First Received on December 15, 2006. Last Updated on August 6, 2009 History of Changes

Sponsor:	Institut Gustave Roussy
Information provided by:	Institut Gustave Roussy
ClinicalTrials.gov Identifier:	NCT00412503

Purpose

Long term survival can now be achieved in 75% of cases of pediatric cancers. However, some types of tumors (ie CNS tumors) or advanced stages (metastatic sarcomas/neuroblastomas) cannot be cured by any treatment. Thus, evaluation of new drugs or combinations are strongly needed. The recommended doses have been defined in children for TMZ (200 mg/m2/d x 5 d) and TPT (1.5 mg/m2/d x 5 d). Some preclinical and clinical studies have shown activity of both drugs in some pediatric cancers. Nevertheless, the association of the two drugs has never been evaluated. The study aims to determine Maximum Tolerated Dose and dose limiting toxicities of each drug when associated and to assess efficacy of the combination.

Condition	Intervention	Phase
Refractory Tumors Malignant Tumors	Drug: Topotecan, Temozolomide	Phase I

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Phase 1 Study of Temozolomide Associated With Topotecan in Refractory or Relapsed Malignant Tumors in Children and Adolescents

Resource links provided by NLM:

MedlinePlus related topics: Cancer

Drug Information available for: Temozolomide Topotecan hydrochloride Topotecan

U.S. FDA Resources

Further study details as provided by Institut Gustave Roussy:

Primary Outcome Measures:

- To determine MTD and DLT of each drug

Secondary Outcome Measures:

To assess safety profile
To evaluate Pharmacokinetic of Temozolomide and Topotecan when associated
To assess the efficacy of the association

Eligibility

Ages Eligible for Study:	6 Months to 21 Years
Genders Eligible for Study:	Both

Criteria

Inclusion Criteria:

histologically documented malignant tumor
refractory or relapsing after conventional treatments and for which there is no curative treatment available
life expectancy > 8 weeks
no significant co-morbidity (NCI-CTC < 2)
No organ toxicity
no chemotherapy within the 4 previous weeks, 6 weeks for nitrosurea or radiotherapy

Exclusion Criteria:

Hypersensibility to Topotecan and/or Temozolomide or to one of their compounds
Hypersensibility to Dacarbazine (DTIC)
Galactosaemia, Glucose and galactose malabsorption syndrom, deficiency in lactase

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00412503

Locations

France
Institut Gustave Roussy
Villejuif, Ille de France, France, 94805

Sponsors and Collaborators

Institut Gustave Roussy

Investigators

Study Chair:

Herve Rubie, MD

CHU Toulouse

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00412503 History of Changes
Other Study ID Numbers:	CSET 1197
Study First Received:	December 15, 2006
Last Updated:	August 6, 2009
Health Authority:	France: Afssaps - French Health Products Safety Agency

Additional relevant MeSH terms:

Neoplasms
Temozolomide
Dacarbazine
Topotecan
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action

Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on February 09, 2012