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


Phase 2
N/A
21 Years
Not Enrolling
Both
Wilms Tumor

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response rate (complete and partial response as per RECIST criteria).

Outcome Time Frame:

5 years

Principal Investigator

Monika Metzger, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

St. Jude Children's Research Hospital

Authority:

United States: Food and Drug Administration

Study ID:

WILTOP

NCT ID:

NCT00187031

Start Date:

November 2002

Completion Date:

October 2007

Related Keywords:

  • Wilms Tumor
  • Wilms Tumor
  • Wilms Tumor

Name

Location
Baylor College of Medicine Houston, Texas  77030
St. Jude Children's Research Hospital Memphis, Tennessee  38105-2794
Children's Healthcare Atlanta, Georgia  30301
Dana Farber Boston, Massachusetts  02115-6084