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

This study is currently recruiting participants.

Verified by Institut Gustave Roussy, September 2007

Sponsored by:	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

MedlinePlus related topics: Cancer

Drug Information available for: Temozolomide Topotecan hydrochloride Topotecan

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Phase 1 Study of Temozolomide Associated With Topotecan in Refractory or Relapsed Malignant Tumors in Children and Adolescents

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

Contacts

Contact: Herve Rubie, MD	00 335 34 55 86 11
Contact: Birgit geoerger, MD	00 331 42 11 46 61

Locations

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

Sponsors and Collaborators

Institut Gustave Roussy

Investigators

Study Chair:

Herve Rubie, MD

CHU Toulouse

More Information

Study ID Numbers:	CSET 1197
Study First Received:	December 15, 2006
Last Updated:	September 18, 2007
ClinicalTrials.gov Identifier:	NCT00412503
Health Authority:	France: Afssaps - French Health Products Safety Agency

Study placed in the following topic categories:

Topotecan
Temozolomide

Additional relevant MeSH terms:

Neoplasms
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses

Enzyme Inhibitors
Antineoplastic Agents, Alkylating
Alkylating Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009