A Phase II Study of Topotecan in Children With Recurrent Wilms Tumor

This study has been completed.
Sponsor:
Collaborators:
GlaxoSmithKline
Information provided by:
St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier:
NCT00187031
First received: September 12, 2005
Last updated: June 3, 2008
Last verified: June 2008
  Purpose

In spite of the overall success of treating Wilms tumor, certain patients still have poor clinical outcomes. The sub-optimal outcomes for patients with anaplastic histology and recurrent Wilms tumor warrant the identification of new therapeutic agents. The objective of this trial is to estimate the response rate to two cycles of intravenous topotecan in children with recurrent Wilms tumor of favorable histology that is refractory to standard curative therapy.


Condition Intervention Phase
Wilms Tumor
Drug: Topotecan, Filgrastim (G-CSF), Pegfilgrastim
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study of Topotecan in Children With Recurrent Wilms Tumor

Resource links provided by NLM:


Further study details as provided by St. Jude Children's Research Hospital:

Primary Outcome Measures:
  • Response rate (complete and partial response as per RECIST criteria). [ Time Frame: 5 years ]

Enrollment: 37
Study Start Date: November 2002
Study Completion Date: October 2007
Arms Assigned Interventions
1 Drug: Topotecan, Filgrastim (G-CSF), Pegfilgrastim
See detailed description section for additional details.

Detailed Description:

Topotecan administered intravenously over 30 minutes daily for 5 consecutive days for 2 consecutive weeks, with a two-day rest given in between the five-day treatment blocks. The topotecan dose started at 1.8 mg/m2/dosage and adjusted to attain a target systemic exposure of 80 plus or minus 10 ng-hr/ml.each cycle consists of 28 days and subsequent cycles can be administered upon hematological recovery. Patients with a CR, PR, or SD, can continue to receive up to a total of six cycles. Patients with PD are removed from the study.

Secondary Objectives include:

  • To describe the anti-tumor activity of topotecan in children with recurrent Wilms tumor of anaplastic histology.
  • To assess the relation between CYP3A4/5 genotype and the pharmacokinetics and pharmacodynamics of topotecan.
  • To assess the relation between ABCG2 genotype and the pharmacokinetics and pharmacodynamics of topotecan.
  Eligibility

Ages Eligible for Study:   up to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Favorable histology Wilms tumor that has recurred or progressed after primary treatment and at least one standard salvage treatment regimen OR anaplastic histology Wilms tumor that has recurred or progressed after primary treatment
  • Age< 21 years of age at the time of study entry
  • Adequate bone marrow function
  • Adequate liver function
  • Adequate renal function
  • Adequate performance status

Exclusion Criteria:

  • Subject is pregnant
  • Subject is lactating
  • Renal tumors other than Wilms tumors
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00187031

Locations
United States, Georgia
Children's Healthcare
Atlanta, Georgia, United States, 30301
United States, Massachusetts
Dana Farber
Boston, Massachusetts, United States, 02115-6084
United States, Tennessee
St. Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105
United States, Texas
Baylor College of Medicine
Houston, Texas, United States, 77030
Canada, Alberta
Tom Baker Cancer Center
Calgary, Alberta, Canada, T2N 4N2
Alberta Children's Hospital
Calgary, Alberta, Canada, T2W 3N2
Canada, Ontario
Hospital of Sick Children
Toronto, Ontario, Canada, M5G 1X8
Sponsors and Collaborators
St. Jude Children's Research Hospital
GlaxoSmithKline
Investigators
Principal Investigator: Monika Metzger, MD St. Jude Children's Research Hospital
  More Information

Additional Information:
Publications:
Responsible Party: Monika Metzger, MD, St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier: NCT00187031     History of Changes
Other Study ID Numbers: WILTOP
Study First Received: September 12, 2005
Last Updated: June 3, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by St. Jude Children's Research Hospital:
Wilms Tumor

Additional relevant MeSH terms:
Wilms Tumor
Neoplasms, Complex and Mixed
Neoplasms by Histologic Type
Neoplasms
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplastic Syndromes, Hereditary
Kidney Diseases
Urologic Diseases
Genetic Diseases, Inborn
Topotecan
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 23, 2014