Neoplasms

All Conditions

Skin and Connective Tissue Diseases

Rare Diseases

Osteosarcoma

Neuroblastoma

Medulloblastoma

Sarcoma, Ewing

Rhabdomyosarcoma

Neoplasms, Connective and Soft Tissue

Sarcoma

Neuroectodermal Tumors, Primitive, Peripheral

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Neuroepithelial

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Neoplasms, Bone Tissue

Neoplasms, Connective Tissue

Myosarcoma

Glioma

Ewing Sarcoma

Soft Tissue Sarcoma

Neuroepithelioma

Antineoplastic Agents

All Drugs and Chemicals

Vinorelbine

Tubulin Modulators

Antimitotic Agents

Vinorelbine, cyclofosfamide

Odile OBERLIN, MD

Annie REY

This is a phase II study to determine the antitumor activity of Vinorelbine and Cyclofosfamide association among patients with refractory tumours or in relapse with rhabdomyosarcomas and other soft tissue tumours, Ewing tumours, osteosarcomas, neuroblastomas or medulloblastomas.

Study of Vinorelbine and Cyclofosfamide Among Patients With Refractory Tumours or in Relapse

Phase II Study of Vinorelbine + Cyclofosfamide Association Among Patients Reached of Refractory Tumours or in Relapse

Gustave Roussy, Cancer Campus, Grand Paris

Glioblastoma

Astrocytoma

Amino Acids

Irinotecan

Gefitinib

Topoisomerase I Inhibitors

Enzyme Inhibitors

Tyrosine Kinase Inhibitors

Protein Kinase Inhibitors

Tyrosine

See Detailed Description for treatment plan.

Irinotecan (Camptosar), Gefitinib (Iressa)

Lisa M McGregor, MD, PhD

The purpose of this Phase I study is to find the largest dose of the drug irinotecan, in combination with ZD1839, that can be given safely to children and to learn the good and bad effects. Studies performed in the laboratory have shown that ZD1839 helps make available the orally administered irinotecan. In this study the intravenous (given into the vein) formula of irinotecan will be given orally on days 1-5 and days 8-12. The dose of ZD1839 will be a fixed dose and will be administered orally on days 1-12. Each course of treatment will consist of 21 days. The administration of irinotecan on day 12 of course 1 and day 2 of course 2 will be an intravenous administration. All other doses and subsequent courses will consist of an orally administered dose.

This is a phase I study to estimate the maximum tolerated dose and the dose limiting toxicities of the intravenous formulation of irinotecan given orally in combination with a fixed dose of oral gefitinib. This trial will use the EWOC method, which is an adaptive dose escalation scheme. The method is fully adaptive and makes use of all the information available at the time of each dose assignment, and directly addresses the ethical need to control the probability of overdosing. It is designed to approach the maximum tolerated dose (MTD) as fast as possible.

In this study the intravenous formulation of irinotecan will be given orally on days 1-5 and days 8-12 (dose level begins at 5 mg/m2 ). One patient will be treated at each dose level of irinotecan until moderate toxicity is observed. At the level where moderate toxicity is observed, the cohort size will be increased to 2 patients. Dosages will then be increased until the development of DLT as guided by the EWOC model. The estimated MTD will be continually reassessed using all data from preceding patients. The toxicity data of all patients enrolled in the trial are used to update the dose-toxicity relationship and to guide the next escalation/de-escalation. The calculation will be carried out with EWOC software. Patients will be enrolled and the dose assigned is determined based on previous participants' toxicity. The dose of ZD1839 will be a fixed dose and will be administered orally on days 1-12 - \[150 mg/m2 (maximum 250 mg)\] Each course of treatment will consist of 21 days. The administration of irinotecan on day 12 of course 1 and day 2 of course 2 will be an intravenous administration. All other doses and subsequent courses will consist of an orally administered dose.

Secondary Objectives Include:

* To describe dose-limiting toxicities (DLTs) of the combination of oral irinotecan and ZD1839 and to define their duration and reversibility.
* To investigate the pharmacokinetics of oral irinotecan and ZD1839 when given in combination in children with recurrent malignant solid tumors.
* To describe the relationship between pharmacokinetic parameters and toxicity.
* To describe any antitumor effects within the confines of a phase I study.
* To examine tumor expression of ErbB1 and/or ABCG2 with respect to pharmacokinetics and response.
* To examine the pharmacogenetic determinants of ZD1839 and irinotecan pharmacokinetics and pharmacodynamics.

ZD1839 and Oral Irinotecan in Treating Young Patients With Refractory Solid Tumors

A Dose Finding Study (Phase I) of the Combination of ZD1839 (Iressa®) and an Oral Formulation of Irinotecan (Camptosar™) in Children With Refractory Solid Tumors

AstraZeneca

St. Jude Children's Research Hospital

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Study of Vinorelbine and Cyclofosfamide Among Patients With Refractory Tumours or in Relapse	NCT00180947	Rhabdomyosarcom... Neoplasms, Conn... Ewing Tumor Osteosarcomas Neuroblastomas Medulloblastoma...	Vinorelbine, cy...	12 Months - 25 Years	Gustave Roussy, Cancer Campus, Grand Paris
ZD1839 and Oral Irinotecan in Treating Young Patients With Refractory Solid Tumors	NCT00132158	Glioblastoma Rhabdomyosarcom... Neuroblastoma Osteosarcoma	Irinotecan (Cam...	- 21 Years	St. Jude Children's Research Hospital
ZD1839 and Oral Irinotecan in Treating Young Patients With Refractory Solid Tumors	NCT00132158	Glioblastoma Rhabdomyosarcom... Neuroblastoma Osteosarcoma	Irinotecan (Cam...	- 21 Years	St. Jude Children's Research Hospital

Spots Global Cancer Trial Database for rhabdomyosarcomas