A Phase II Study of Topotecan in Children With Recurrent Wilms Tumor
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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 |
- 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 |
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| 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 | |
| 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 May 16, 2013